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Sunday, September 5, 2021

Sex education in the United States

From Wikipedia, the free encyclopedia

Sex education in the United States is taught in two main forms: comprehensive sex education and abstinence-only. Comprehensive sex education is also called abstinence-based, abstinence-plus, abstinence-plus-risk-reduction, and sexual risk reduction sex education. This approach covers abstinence as a choice option, but also informs adolescents about human sexuality, age of consent and the availability of contraception and techniques to avoid contraction of sexually transmitted infections.

Abstinence-only sex education is also called abstinence-centered, abstinence-only-until-marriage, sexual risk avoidance, and most recently, youth empowerment sex education. This approach emphasizes abstinence from sexual activity prior to marriage and rejects methods such as contraception. These two approaches are very different in philosophy and strategies for educating young people about their sexuality. The difference between the two approaches, and their impact on the behavior of adolescents, remains a controversial subject in the United States.

Current position

List of "19 Critical Sexual Education Topics" published by the US Centers for Disease Control and Prevention in 2016

Sex education programs in the United States teach students about sexual health as well as ways to avoid sexually transmitted diseases and unwanted teenage pregnancy. The three main types of programs are abstinence-only, abstinence-plus, and comprehensive sex education. Although sex education programs that only promotes abstinence are very prominent in American public schools, comprehensive sex education is known to be the most effective and is proven to have helped young people make better decisions. Sex education has many benefits as it educates students about the human anatomy and teaches the importance of having healthy relationships. Adequate sex education programs in public schools greatly benefit students and have the potential to reduce the high percentages of sexually transmitted diseases and unwanted pregnancies in America.

Most adolescents in the United States receive some form of sex education at school at least once between grades 6 and 12; many schools begin addressing some topics as early as grades 4 or 5. Academic and other proponents of the National Sexuality Education Standards advocate that by the end of the fifth grade, students should be able to "Define sexual orientation as the romantic attraction of an individual to someone of the same gender or a different gender." However, what students learn varies widely, because curriculum decisions are so decentralized. Many states have laws governing what is taught in sex education classes or allowing parents to opt out. Some state laws leave curriculum decisions to individual school districts.

National public health goals for adolescents recommend providing a comprehensive sex education, which covers a wide array of topics and call for "increasing the share of adolescents receiving formal instruction about abstinence, birth control methods, and prevention of HIV/AIDS and STIs." Despite the aims national public health goals, research has indicated a growing gap between them and adolescents receipt of sex education. Data from the National Survey of Family Growth, a nationally representative household survey conducted by the National Center for Health Statistics, asked respondents if prior to age 18 they had ever received "any formal instruction at a school, church, a community center or some other place" about a range of sex education topics. During the period 2011–2013, data from the NSFG showed that among adolescents aged 15–19, similar proportions of females and males reported receiving formal instruction, with the share receiving instruction about birth control methods (60% females, 55% males) lower than the share receiving instruction about saying no to sex, sexually transmitted diseases, or HIV/AIDS. Many sexually experienced teens (43% females and 57% of males) do not receive formal instruction about contraception before they first have sex; the share of adolescents receiving formal instruction has been declining. Between 2006-2010 and 2011–2013, there were declines in the proportion of females ages 15–19 who reported receiving instruction on birth control, saying no to sex, HIV/AIDS and sexually transmitted diseases, as well as a decline in the proportion of males who reported receiving formal instruction about birth control. Both males and females reported an increase in receiving instruction on saying no to sex, without being provided information about birth control.

The NSFG also documents large declines in formal instruction about birth control from 1995 to 2011-2013 falling from 87% to 60% of adolescent females and 81% to 55% of adolescent males. Although formal instruction on birth control has significantly declined, 9 out of 10 adolescents report receiving formal instruction about STDs.

Curriculum

Common curriculum in American schools' sex education classes include "instruction on sexual health topics including human sexuality. HIV or STD prevention and pregnancy prevention are more commonly required in high school than in middle or elementary school." Statistics provided by the Center for Disease Control (CDC) reveal that between 2000 and 2014 the portion of schools providing information on sexual health education, including topics such as abstinence, puberty, and how to properly use a condom, declined. The CDC has identified 19 Critical Sexual Education Topics that should be taught in all middle and high schools. In 2014, fewer than half of high schools and only 20% of middle schools provided instruction on all 16 topics that the CDC considers essential to sexual health education.

High school

A statistics and policy report, based on CDC data and published by Guttmacher Institute, shows that in 2014 72% of private and public high schools within the United States provided information on pregnancy prevention, and 76% taught that abstinence is "the most effective method to avoid pregnancy, HIV and other STDs." Although 61% of U.S. private and public high schools taught about contraceptive efficacy, only 35% required instruction on teaching students how to properly use a condom. Within the demographic of United States public and private high schools which taught pregnancy prevention, the average time spent in class teaching this topic was 4.2 hours.

Middle school

Statistics released by the CDC regarding public and private middle schools' within the United States policies and requirements on sex education in 2014 revealed that 30% of public and private U.S. middle schools included information about pregnancy prevention, 50% taught abstinence as the "most effective method to avoid pregnancy, HIV, and other STDs." 20% of U.S. public and private middle schools included instruction about contraceptive efficacy, and 10% required instruction to teach students how to properly use a condom. The CDC report also found that, on average, 2.7 hours of instruction about pregnancy prevention was required by U.S. public and private middle schools.

Elementary school

Traditionally, schools have begun teaching sex education in fifth and sixth grade, focusing primarily on puberty and reproductive anatomy and physiology. Sex education in these grades is often referred to as puberty education in order to reflect the emphasis on preparing children for the changes that all humans experience as they develop into adults. Little data is available for how much sex education is taught in elementary, but increasing numbers of schools are beginning developmentally appropriate sex education beginning in kindergarten in alignment with the National Sexuality Education Standards (NSES).

Public opinion

There have been numerous studies on the effectiveness of both approaches, and conflicting data on American public opinion. Public opinion polls conducted over the years have found that the majority of Americans favor broader sex education programs over those that teach only abstinence, although abstinence educators recently published poll data with the opposite conclusion. The poll sponsored by the National Abstinence Education Association (now called Ascend) and conducted by Zogby International reported information that has not been replicated in methodologically sound surveys.

Experts at University of California, San Francisco also encourage sex educators to include oral sex and emotional concerns as part of their curriculum. Their findings also support earlier studies that conclude:

...that sexual risk-taking should be considered from a dynamic relationship perspective, rather than solely from a traditional disease-model perspective. Prevention programs rarely discuss adolescents' social and emotional concerns regarding sex.... Discussion about potential negative consequences, such as experiencing guilt or feeling used by one's partner, may lead some adolescents to delay the onset of sexual behavior until they feel more sure of the strength of their relationship with a partner and more comfortable with the idea of becoming sexually active. Identification of common negative social and emotional consequences of having sex may also be useful in screening for adolescents at risk of experiencing more-serious adverse outcomes after having sex.

Sex education is still a debate in the United States to this day. Some parents believe that their children's school programs encourage sexual activity, and the schools believe that there are many students that do not get any sex education at home. The goal for the parents is for their children to follow their family values. Parents want the ability to teach their children what they want about sex education rather than school programs teaching them of things that certain things that parents are trying to avoid. Sex education programs in schools are mainly trying to give the students a complete picture about sex and sexuality. They want students to know their bodies as well as know how to protect them and make smart decisions. In a study titled "Emerging Answers: Research Findings on Programs to reduce Teen Pregnancy" showed that sex education programs in schools are having a huge impact on teen's decisions to remain abstinent or to use contraceptives if they do choose to have intercourse (1). School programs are teaching students everything they need to know about sex and sexuality and that is helping these same students to make their own decisions and to be safe no matter what they choose to do. Successful sex education programs are stated as those that tailor the curricula to students specific needs, address peer pressure and ways to respond to it, and discuss content in a way that is appropriate for students' age groups and level of sexual experience, all while providing accurate information.

Near-peer teaching

In a standard classroom, you have a teacher passing on health information to their students. One student recalls sexual health education being taught through, "a book, [a] teacher, and a PowerPoint… and the teacher made it awkward." The near peer teaching model differs from that of a regular teaching curricula. A near peer teaching model is when a more experienced student acts as the instructor and passes on their knowledge and experience to the students.

Benefits of near-peer teaching

Near-peer model has been deemed effective due to its high levels of effect communication between the peer educators and the students, thus is often used to teach health education and bio-sciences. Additionally, it has been used as tool for peer educators to enhance their teaching and leadership skills. Other studies show that there are positive academic outcomes for not only the students receiving the education, but the peers teaching the education. This is due to the fact there is a gain in social constructivism, a theory that states individuals conceptualize material through social interactions. Additionally, educators develop a new understanding of the material they are teaching, because they often create their own explanations, which is found to have the largest academic gains. Research was conducted in 11 different settings which analyzed health behaviors of those that received peer-led health education versus that received adult-led health education. Results showed that 7 out of the 11 trials were more effective with the peer taught model. It also depicted greater positive changes in health behavior with a peer model compared to that of adults. It was seen to reduce smoking, marijuana, and alcohol usage.

Some examples of successful near-peer teaching models are listed below:

Teen Prevention Education Program (Teen PEP)

In New Jersey and North Carolina high schools, the Teen Prevention Education Program (Teen PEP) is implemented. It is one out of 19 programs funded under the Office of Adolescent Health's Teen Pregnancy Prevention (TPP) aimed at reducing teen pregnancy. Unlike other TPP programs, Teen PEP's main focus is implementing the peer education component, 11th and 12th-grade students are peer educators teaching sexual health to ninth grade students in their second semester. Teen PEP focused in 3 broad areas: cognitive and behavioral, connectedness and self-concept, and changes in information or knowledge. Results shows a positive impact of this model. Due to the fact that peer educators are closer in age to the students, students across all schools felt that they were more approachable and reliable than teachers since they share more common experiences. One student stated, "I liked this. I learn better from younger kids that have been in my situation." Additionally, 70% of the students noted that Teen Pep has helped them care about graduating from high school, know where to get birth control, and know when they need to see a health care provider. Furthermore, peer educators were proven to be effective instructors. Over 95% of the students claimed that the peer educators were organized, prepared, gave explicit instructions.

Peer Health Exchange

In 1999, six Yale undergraduate students began teaching health workshops in New Haven public schools to bridge the funding gap in health programs. In 2003 these same six students created Peer Health Exchange (PHE), in which college undergraduate students teach comprehensive health education to 9th grade students in Title I schools. PHE is a 501(c)3 organization and focuses on four main areas: sexual health, mental health, substance abuse, and communication and advocacy over the course of 13 workshops. Since its emergence PHE has over 2,000 college student volunteers that serve over 17,000 public high school students in the Bay area, Boston, Chicago, Los Angeles, New York City, and Washington, DC. The purpose of having peer health educators is so that conversations with high school students, regarding health, are more honest and real. In research completed by American Institutes for Research (AIR), statistics stated that students were 17% more likely to visit a health center after completion of the 13 workshops compared to those that did not received the PHE workshops. Additionally, students who received the 13 workshops had higher rates of accurately define consent, knowing how access contraceptives, and identifying signs of poor mental health compared to those who did not.

It's Okay to Ask Someone (IOTAS)

Peer education has seemed to improve sexual health outcomes by having positive effects on sexual health knowledge, intentions, and attitudes. This study aimed to analyze the effectiveness of peers intervening via text messaging to promote sexual health. Studies showed that 88% of American teens (ages 13–17) had access to a mobile phone of some kind in 2015. The, It's Okay to Ask Someone (IOTAS) app, was created in 2014 with funding form the Forbes Fun and curricula collaboration with the Planned Parenthood of Western Pennsylvania (PPWP) Education Department. The app's main purpose was to serves as a sexual health text line that would reach beyond the classroom, in which peer educators could participate in by responding to students questions with adult oversight. The PPWP Education Department made sure that the peer educators received appropriate training for answering sexual health question and navigating the app; they developed an 8-lesson student curriculum. The app was then launched in four high schools in western Pennsylvania in which peer educators answered student questions. IOTAS was successful and deemed to be time-effective in answering questions all while upholding the confidentiality of sexual health information beyond the classroom. It also allowed the peer educators to be more involved in their communities and expand their own sexual health knowledge, thus it was great for both those who were receiving and getting the information.

Planned Parenthood

Teen Health Source is a program facilitated by Planned Parenthood Toronto, Canada, in which trained youth volunteers (ages 16–19) answer sexual health questions from teens (age 13–19) via text, email, phone, or their chat website, manages their blog website, and refers teens to local and community resources such as free clinics. It began in 1993 as a sexual health info line where teens could call and get their sexual health questions answered anonymously and confidentially from adults. Since then it has emerged into a near peer model in which youth volunteers are available five days a week (Mondays-Thursdays between 4 p.m. and 9 p.m. and Saturdays between 12 and 5 p.m.) to chat online. They cover a wide range of sexual health topics, some of which include: birth control, sexually transmitted infections, healthy relationships, consent, sexual pleasure, orientation, gender, virginity, puberty, and more.

Additionally, Planned Parenthood of Western Pennsylvania (PPWP)'s has a Peer Helpers peer education program which 250 peer students serve 7 middle and high schools to deliver comprehensive health education. It is run by the PPWP Education Department and their main goal is pregnancy prevention. It started to become less effective due to overcrowding and students not wanting to ask their questions in person. Therefore, the PPWP Education Department switched to the IOTAS model which is described above.

Criticisms of near-peer teaching

There are also some drawbacks with near-peer teaching.

Time commitment

It is hard to sustain due to the time commitment it requires of peers. This time commitment requires the peer to become experts in health knowledge which is impractical.

Classroom Management

A study analyzed peer health educators in 12th grade of high school (ages 16/17) who taught a minimum of three sex education classes to about 30 students in the 9th grade. The results showed that 9th grade students did not perceive educators as having the same authority as teachers, therefore it was difficult for peer educators to have control over the classroom. It was also noted that it was more difficult for male peer educators to control the classroom because of tensions flowing from preconceptions and stereotypical views about male behavior and the role of men in managing groups. Furthermore, 27% of peer educators indicted that they had either "a lot" or "quite a lot" of difficulty managing behavior in the classroom such as addressing comments, bullying, and inappropriate questions. They also had difficulty managing noise levels.

Time constraints

In addition, 20% of the peer educators reported they encountered time management issues; there was not enough time in each lesson to deliver the sex education. The timing of the lessons were another problem. Educators reported that when they taught at the end of the day, students were tired and not engaged. Additionally, the constraints of the school schedule also made it difficult. Sometimes lessons would be cancelled, or the delivery of lessons would have long gaps due to the school schedule therefore, the lesson that followed would not be as effective.

Lack of teacher support

Sometimes teachers were not supportive of the work that peer educators were doing. Peer educators stated they would have appreciated some affirmations for their contributions. Other educators stated that they did not receive advice on classroom management for the teachers and/or would have liked help managing the classroom. Others noted that they did not receive help in finding resources such as writing materials.

Recommendations for near-peer teaching programs

Below are 6 six recommendations one should consider in order to have an effect near peer teaching program and avoid common drawbacks.

  1. Identify what type of interaction you wish your peer educators and students have. Then develop a training for peer educators that include classroom management skills such as how to deal with bullring and how to address comments.
  2. The peer educator's training and student lessons should have clear objectives, be engaging and fun, have relevance to the students, be practical, and should involve learning something new.
  3. Reassure peer educators that even the most difficult students are able to engage well with peers. This can be done through creating relationships by using humor.
  4. Do not let more than a few weeks elapse between lessons nor the period between the peer educator's training and delivery of lessons.
  5. Make sure there is an adequate amount of space to teach the lesson and that the lessons are not taught at the end of the day. Emphasize working in small groups and if feasible have peer educators give multiple lessons to the same group of students.
  6. Teachers should be actively engaged by supporting peer educators. Teachers should show appreciation to peer educators, provide them with resources, and make sure to work around the school schedule for lessons.

Parental support

A 2004 NPR survey indicated that the majority of the 1001 parent groups polled wanted complete sex education in schools, as over 80% agreed with the statement "Sex education in school makes it easier for me to talk to my child about sexual issues", and under 17% of polled parents agreed with the statement that their children were being exposed to "subjects I don't think my child should be discussing". An additional 90% believed that their children's sexual education was "not too early", and 49% of the respondents were "somewhat confident" that the values taught in their children's sexual education classes were similar to those taught at home, with 23% of polled parents being somewhat less confident. 

Regional parental support

Since the 2004 NPR survey, many researches have collected data indicating parental support on a statewide level.

A 2014 study in Florida, supported by the Behavioral Risk Factor Surveillance System (BRFSS) Survey administration and Florida Department of Health, questioned parents with school-age children for their perspectives on questions regarding school-based sex education. When the 1,715 participants were asked for their opinion regarding curriculum options, the majority group, 40.4%, supported comprehensive sex education (CSE), 23.2% favored abstinence-only, and 36.4% supported "abstinence-plus". Similar to CSE, "Abstinence-plus" sex education includes information about contraception and condoms; however, this information is presented in the "context of strong abstinence messages", such as reinforcing the importance of faithfulness. When asking about the inclusion of individual topics, the survey found that 72%-91% of parents supported high school education which included birth control and condom education in addition to communication skills, human anatomy/reproductive information, abstinence, HIV, STDs, STIs, and gender/sexual orientation issues. When asked about individual topics to be taught in middle school, 62%-91% of parents supported the previously listed topics. Parents were also asked about sexuality education topics being taught in elementary school, and 89% supported the inclusion of communication skills, 65% supported education on human anatomy and reproductive information, 61% supported the inclusion of information about abstinence, 53% supported information on STDs, HIV, and STIs and 52% supported education about gender and sexual orientation issues. A 2011 study in Harris County Texas, conducted by the University of Texas Health Center, revealed that of the 1,201 parents who completed the survey, 93% of parents supported teaching sex education in school, 80% felt that sex education instruction should begin in middle school or prior to middle school and two thirds of survey participants felt that information about condoms and contraception should be included in sex education curriculum. The study also noted that Hispanic parents demonstrated the strongest support for school-based education which is medically accurate, and provides information on condoms and contraception.

A 2007 survey in Minneapolis Minnesota, conducted by the Division of Adolescent Health and Medicine at University of Minnesota, included 1,605 participants with school-age children who responded to telephone survey questions regarding items and attitudes towards sex education. 83% of parents supported CSE (comprehensive sex education) which teaches both contraception and abstinence. The survey demonstrated popular support for comprehensive sex education; the odds of parents who favored CSE as a more effective method for sex education than abstinence-only curriculum were 14.3 to 0.11. The survey revealed that parental for the inclusion of specific individual topics in school-based sex education was also high, ranging from 98.6% to 63.4%. The majority of parents also felt that school-based sex education should begin in middle school, or earlier.

A 2006 California survey asked 1,284 randomly selected, digitally-dialed parents of school-aged children for their perspectives on various matters regarding school-based sex education. When asked about curriculum preference 89% of parents overall preferred comprehensive sex education over the 11% who preferred abstinence-only curriculum. Among all of the regions surveyed, 87%-93% of parents supported CSE. The survey found that 64% of the 11% of respondents who supported abstinence-only curriculum cited absolutist reasons, such as purity-based morality concerns, as the basis for their preference. Of the CSE supporters, 94% cited at least one of the following three reasons; "those focused on the consequences of actions, on the importance of providing complete information, on the inevitability of adolescents' engaging in sex."

Federal funding

Federal Funding for Sex Education 2011

FY 2016 federal budget

In FY 2016 Congress provided $176 million in federal funding for sex education programs which were both medically accurate and age appropriate.

The funding includes the December 16, 2015 release of the FY 2016 Omnibus Funding Bill, The Consolidated Appropriations Act. The Omnibus Bill includes $101 million of level funding for TPP, the Teen Pregnancy Prevention Program from the Office of Adolescent Health (OAH). Evaluation funding in the FY 2016 Omnibus Bill remained at $6.8 million, as it had been in FY 2015. The Center for Disease Control's Division of Adolescent School and Health (DASH) was funded a $2 million increase from the previous year's funding level, resulting in $33.1 million in federal funding. $75 million was funded to the Personal Responsibility Education Program, an inclusive education program which provides information on contraception and the prevention of pregnancy and STI's and abstinence.

In FY 2016, $85 million was provided to abstinence education programs, including doubling annual funding for "AOUM" programs to $10 million, which may only be allotted to programs which promote abstinence only sex education, and the importance of refraining from any kind of sexual contact until marriage, (see A.O.U.M. sub-heading for more). Congress also provided $75 million to the Title V Abstinence education program, which includes an eight-point definition of abstinence-only education, and teaches that, regardless of age or circumstance, sex outside of marriage will lead to "harmful physical and psychological effects."

FY 2017 proposed budget

As of July 11, 2016:

On July 7, 2016 The House of Appropriations Labor, Health and Human Services and Education (LHHS) Subcommittee passed its draft of the Federal Budget, eliminating the TPP Program, funded in FY (Fiscal Year) 2016 at $101 million, and Title X Family Planning program, funded in FY 2016 at $286.5 million. In the LHHS's version of the bill, these programs are to be replaced with $20 million provided to "Sexual Risk Avoidance", or the abstinence education grant program. The Teen Pregnancy Prevention Program has contributed to a successful 35% decrease in teen pregnancy rates since its implementation in 2010, which is more than double the decline in teen pregnancy rates than any other sex education program has seen in the United States.

The Senate proposed their version of the bill, which provided level funding for both TPP and Title X Family Planning, one month prior. The Senate's bill included $15 million in funding for the competitive abstinence education grant program and $5 million funding increase over FY 2016, as opposed to LHHS's proposed $20 million for the competitive abstinence education grant program and $10 million increase over FY 2016.

As of July 11, 2016, the House has not released a deadline for a decision on whether of not the bill will officially pass and cut funding for TPP and the Family X Program, or consider the Senate's version of the bill.

Federal funding policy changes in 2010

In 2010, Congress eliminated two federal programs that had funded abstinence-only education; the Adolescent Family Life (AFL) Prevention program and the Community-Based Abstinence Education (CBAE) program; $13 million and $99 million a year, respectively for a total of $112 million a year. The CBAE program was replaced in the FY 2010 Consolidated Appropriations Act, with a $114.5 million budget that includes $75 million provided to "go toward replicating programs that have been proven through rigorous evaluation to reduce teen pregnancy or its underlying or associated risk factors. A smaller pot ($25 million) is reserved to develop innovative strategies that have demonstrated at least some promise, and an additional $14.5 million is set aside for training, technical assistance, evaluation, outreach, and additional program support activities."

That same year, two new evidenced-based sex education programs were initiated; the Personal Responsibility Education Program (PREP), and the Teen Pregnancy Prevention (TPP) initiative; $55 million and $100 million, respectively, for a total of $155 million a year.

Funding for Title V, Section 510 abstinence-only education had expired in 2009, but was reinstated by a provision in the 2010 health care reform law by Senator Orrin Hatch. Although this funding stands at $50 million a year, only $33 million seems to have actually been awarded.

As of spring 2016, at implementation of federal funds is determined and allocated at state, individual state, district, and school board level. In 2014, the CDC conducted a "School Health Policies and Practices" study which revealed that, on average, schools require providing approximately 6.2 hours of education on human sexuality, with 4 or less hours of information on STD's, HIV, and pregnancy prevention.

A.O.U.M.

"A.O.U.M" is an acronym, which stands for "abstinence only until marriage". A.O.U.M is a federally-funded policy for sex education that was developed in the 1990s as a part of welfare reform, partially in reaction to the growth and development of adolescent sex and HIV education programs spanning the 1960s, 1970s and 1980s.

In-depth research has shown that the A.O.U.M policy has little influence over preventing students from engaging in sexual activity, is ineffective in reducing "sexual risk behaviors" and fails to improve the health outcomes of increasing contraceptive use and decreasing teen pregnancy rates.

Despite its lack of efficacy, the United States congress has continued to fund A.O.U.M., increasing funding to $85 million a year in FY2016. President Barack Obama unsuccessfully attempted to terminate A.O.U.M, due to "10 years of opposition and concern from medical and public health professionals, sexuality educators, and the human rights community that AOUM withholds information about condoms and contraception, promotes religious ideologies and gender stereotypes and stigmatizes adolescents with non-heteronormative sexual identities."

Sex education debates

Coined by Nancy Kendall, the "sex education debates" refers to the current binarized conversation surrounding sex education within the United States. The two sides, which supposedly exist in direct opposition to each other, are most commonly known as Abstinence-Only versus Comprehensive Sex Education. According to Kendall, this debate pertains mainly to which style of teaching is most "effective" and "appropriate" for adolescents in both private and public schools. The debate itself consists of each side continuously criticizing the other for not reducing rates of unplanned pregnancy, transmission of STIs, and for not postponing first sexual activity in students. These criticisms are generally dealt in the form of studies conducted or sponsored by Abstinence-Only or Comprehensive advocates, with the intent of once and for all convicting the other side of ineffectively educating.

The sex ed debates have been critiqued as the main cause of the inadequacy of most current curriculums; these curriculums spend the majority of their material obsessing over preventing STIs and teen pregnancy, rather than teaching about the emotional components of sexuality. These emotional components include but are not limited to topics of consent, pleasure, love, and constructive conversation techniques. Kendall articulates that amongst other factors, the debates have detrimental impacts on both teachers' and students' experiences in the sex ed classroom. The cycle of the sex education debates (the seemingly endless attempts to disprove the "other" method) currently holds the focus of the field of sex education, slowing the creation and publication of potentially enriching materials.

Comprehensive Sex Education

A 2002 study conducted by the Kaiser Family Foundation found that 58% of secondary school principals describe their sex education curriculum as comprehensive.

The American Psychological Association, the American Medical Association, the National Association of School Psychologists, the American Academy of Pediatrics, the American Public Health Association, the Society for Adolescent Medicine and the American College Health Association, have all stated official support for comprehensive sex education. Comprehensive sex education curricula are intended to reduce sexually transmitted disease and out-of-wedlock or teenage pregnancies. According to Emerging Answers 2007: Research Findings on Programs to Reduce Teen Pregnancy and Sexually Transmitted Diseases by Douglas Kirby, Ph.D, "a large body of evaluation research clearly shows that sex and HIV education programs included in this review do not increase sexual activity – they do not hasten the onset of sex, increase the frequency of sex, and do not increase the number of sexual partners."

The Future of Sex Education Project (FoSE) began in July 2007 when staff from Advocates for Youth, Answer and the Sexuality Information and Education Council of the U.S. (SIECUS) first met to discuss the future of sex education in the United States. At the time, each organization was looking ahead to the possibility of a future without federal abstinence-only-until-marriage funding and simultaneously found themselves exploring the question of how best to advance comprehensive sexuality education in schools. In May 2008, Advocates, Answer and SIECUS formalized these discussions with funding from the Ford Foundation, George Gund and Grove Foundations, and the FoSE Project was launched. The purpose of the project is to create a national dialogue about the future of sex education and to promote the institutionalization of comprehensive sexuality education in elementary schools. In "Sexuality Education in the United States: Shared Cultural Ideas across a Political Divide", Jessica Fields discusses that sexuality education seeks behavioral change, and believes that worded in specific terms, can be transparent and neutral. At the heart of sexuality debates, practice, and sexuality education lies a stable, rational, and unambiguous relationship between knowledge and behavior.

Proponents of this approach argue that sexual behavior after puberty is a given, and it is therefore crucial to provide information about the risks and how they can be minimized. They hold that abstinence-only sex ed and conservative moralizing will only alienate students and thus weaken the message. When information about risk, prevention, and responsible behavior is presented, it promotes healthy decision-making in youth.

A report issued by the Department of Health and Human Services has found the "most consistent and clear finding is that sex education does not cause adolescents to initiate sex when they would not otherwise have done so." The same report also found that:

Family life or sex education in the public schools, which traditionally has consisted largely of providing factual information at the secondary school level, is the most general or pervasive approach to preventing pregnancy among adolescents....Adolescents who begin having sexual intercourse need to understand the importance of using an effective contraceptive every time they have sex. This requires convincing sexually active teens who have never used contraception to do so. In addition, sexually active teens who sometimes use contraceptives need to use them more consistently (every time they have sex) and use them correctly.

Comprehensive sex education curricula offer medical data that is presented in an age appropriate manner. A wide spectrum of topics is covered in these programs, which include abstinence, contraception, relationships, sexuality and the prevention of disease (Siecus). The main focus is to educate youth so that they can make an informed decision about their own sexual activity and health. Studies have shown that the comprehensive programs work for youth population across the spectrum. Inexperienced, experienced, male, female, the majority of ethnic groups, and different communities all benefited from this type of curriculum. Yet unlike its counterpart, comprehensive sex education programs are ineligible for federal funding due to mandates against educating youth about contraception (Advocates For Youth). The proposed Responsible Education About Life Act (S. 972 and H.R. 1653) would provide federal funding for comprehensive sex education programs which include information on both abstinence and contraception and condoms.

From November 2-6th, 2013, the American Public Health Association will be holding a meeting in Boston, MA regarding a revolutionary new teaching method in regards to Sexual Education. Developed in Los Angeles in 2008, by the UCLA Art & Global Health Center and the LA public schools, the program "Focuses on self-empowerment and open dialogue about sexual health..the interventions include a performance of original material created by college students (known as Sex or Sex-Ed Squads), testimonials by HIV-positive people, and an interactive condom negotiation session." The presentation in November is to gain support for the notion that these art-based approaches are a capable means of education within the public health field 

Abstinence-only sex education

Abstinence-only sex education, also referred to as "abstinence only until marriage" (A.O.U.M) is an approach which emphasizes sexual abstinence prior to marriage to the exclusion of all other types of sexual and reproductive health education, particularly regarding birth control and safe sex. Adolescents are encouraged to be sexually abstinent until marriage and are not provided with information about contraception.

A.O.U.M. is a federally-funded policy for sex education that was developed in the 1990s as a part of welfare reform, partially in reaction to the growth and development of adolescent sex and HIV education programs spanning the 1960s, 1970s and 1980s.

Through direct funding and matching grant incentives, the U.S. government steered more than 1.5 billion dollars to abstinence-only education programs between 1996 and 2010.

In 1996, the federal government attached a provision to a welfare reform law establishing a program of special grants to states for abstinence-only-until-marriage programs. The program, Title V, § 510(b) of the Social Security Act (now codified as 42 U.S.C. § 710b), is commonly known as Title V. It created very specific requirements for grant recipients. Under this law, the term "abstinence education" means an educational or motivational program which:

  1. Has as its exclusive purpose teaching the social, psychological, and health gains to be realized by abstaining from sexual activity;
  2. Teaches abstinence from sexual activity outside marriage as the expected standard for all school-age children;
  3. Teaches that abstinence from sexual activity is the only certain way to avoid out-of-wedlock pregnancy, sexually transmitted diseases, and other associated health problems;
  4. Teaches that a mutually faithful monogamous relationship in the context of marriage is the expected standard of sexual activity;
  5. Teaches that sexual activity outside of the context of marriage is likely to have harmful psychological and physical effects;
  6. Teaches that bearing children out of wedlock is likely to have harmful consequences for the child, the child's parents, and society;
  7. Teaches young people how to reject sexual advances and how alcohol and drug use increase vulnerability to sexual advances, and
  8. Teaches the importance of attaining self-sufficiency before engaging in sexual activity.

Title V-funded programs were not permitted to advocate or discuss contraceptive methods except to emphasize their failure rates.

In 2000, the federal government began another large program to fund abstinence education, Community-Based Abstinence Education (CBAE). CBAE became the largest federal abstinence-only funding source, with $115 million granted for fiscal year 2006. The CBAE awards bypass state governments, offering federal grants directly to state and local organizations that provide abstinence-only education programs. Many of these grantees are faith-based or small non-profit organizations, including crisis pregnancy centers, which use their grants to provide abstinence-only programs and services in local public and private schools and to community groups.

In 2010, the Obama administration and Congress eliminated two federal abstinence-only programs - the Community-Based Abstinence Education (CBAE) grant program and the Adolescent Family Life Act (AFLA) Prevention program. The Title V program remains the only federal abstinence education program.

Evidence of effectiveness of A.O.U.M

While abstinence-only sex education is a controversial subject, the fact that complete abstinence itself (even within marriage) is the most effective preventative measure against both pregnancy and sexually transmitted infections has never been in dispute. What is in dispute is whether abstinence-only sex education actually succeeds in increasing abstinence. Various analyses show that abstinence-based programs have little to no effect on age of sexual initiation, number of sexual partners, or rates of abstinence, use of condoms, vaginal sex, pregnancy, or sexually transmitted diseases. In-depth research has shown that the A.O.U.M policy has little influence over preventing students from engaging in sexual activity, is ineffective in reducing "sexual risk behaviors" and fails to improve the health outcomes of increasing contraceptive use and decreasing teen pregnancy rates.

Despite its lack of efficacy, the United States congress has continued to fund A.O.U.M., increasing funding to $85 million a year in FY2016. President Barack Obama unsuccessfully attempted to terminate A.O.U.M, due to "10 years of opposition and concern from medical and public health professionals, sexuality educators, and the human rights community that AOUM withholds information about condoms and contraception, promotes religious ideologies and gender stereotypes and stigmatizes adolescents with non-heteronormative sexual identities."

Criticism of abstinence-only sex education in the U.S. Congress

Two major studies by Congress have increased the volume of criticism surrounding abstinence-only education.

In 2004, U.S. Congressman Henry Waxman of California released a report that provides several examples of inaccurate information being included in federally funded abstinence-only sex education programs. This report bolstered the claims of those arguing that abstinence-only programs deprive teenagers of critical information about sexuality. The claimed errors included:

  • misrepresenting the failure rates of contraceptives
  • misrepresenting the effectiveness of condoms in preventing HIV transmission, including the citation of a discredited 1993 study by Dr. Susan Weller, when the federal government had acknowledged it was inaccurate in 1997 and larger and more recent studies that did not have the problems of Weller's study were available
  • false claims that abortion increases the risk of infertility, premature birth for subsequent pregnancies, and ectopic pregnancy
  • treating stereotypes about gender roles as scientific fact
  • other scientific errors, e.g. stating that "twenty-four chromosomes from the mother and twenty-four chromosomes from the father join to create this new individual" (the actual number is 23).

Out of the 13 grant-receiving programs examined in the 2004 study, the only two not containing "major errors and distortions" were Sex Can Wait and Managing Pressures Before Marriage, each of which was used by five grantees, making them two of the least widely used programs in the study. With the exception of the FACTS program, also used by 5 grantees, the programs found to contain serious errors were more widely used, ranging in usage level from 7 grantees (the Navigator and Why kNOw programs) to 32 grantees (the Choosing the Best Life program). Three of the top five most widely used programs, including the top two, used versions of the same textbook, Choosing the Best, from either 2003 (Choosing the Best Life) or 2001 (Choosing the Best Path — the second most widely used program with 28 grantees — and Choosing the Best Way, the fifth most widely used program with 11 grantees).

In 2007, a study ordered by Congress found that middle school students who took part in abstinence-only sex education programs were just as likely to have sex in their teenage years as those who did not. From 1999 to 2006, the study tracked more than 2,000 students from age 11 or 12 to age 16; the study included students who had participated in one of four abstinence education programs, as well as a control group who had not participated in such a program. By age 16, about half of each group students in the abstinence-only program as well as students in the control group were still abstinent. Abstinence program participants who became sexually active during the 7-year study period reported having similar numbers of sexual partners as their peers of the same age; moreover, they had sex for the first time at about the same age as other students. The study also found that students who took part in the abstinence-only programs were just as likely to use contraception when they did have sex as those who did not participate. Abstinence-only education advocates claim the study was too narrow, began when abstinence-only curricula were in their infancy, and ignored other studies that have shown positive effects.

Other criticisms of abstinence-only sex education include emphasizing conventional gender and heterosexual norms and expression, excluding members of the LGBT community. LGBT community members cannot always utilize programs or recommendations from abstinence-only programs as they are not geared toward transgender and homosexual relationships.

Criticism of abstinence-only sex education by the scientific and medical communities

Abstinence-only education has been criticized in official statements by the American Psychological Association, the American Medical Association, the National Association of School Psychologists, the Society for Adolescent Medicine, the American College Health Association, the American Academy of Pediatrics, and the American Public Health Association, which all maintain that sex education needs to be comprehensive to be effective.

The AMA "urges schools to implement comprehensive... sexuality education programs that... include an integrated strategy for making condoms available to students and for providing both factual information and skill-building related to reproductive biology, sexual abstinence, sexual responsibility, contraceptives including condoms, alternatives in birth control, and other issues aimed at prevention of pregnancy and sexual transmission of diseases... [and] opposes the sole use of abstinence-only education..."

The American Academy of Pediatrics states that "Abstinence-only programs have not demonstrated successful outcomes with regard to delayed initiation of sexual activity or use of safer sex practices... Programs that encourage abstinence as the best option for adolescents, but offer a discussion of HIV prevention and contraception as the best approach for adolescents who are sexually active, have been shown to delay the initiation of sexual activity and increase the proportion of sexually active adolescents who reported using birth control."

On August 4, 2007, the British Medical Journal published an editorial concluding that there is "no evidence" that abstinence-only sex education programs "reduce risky sexual behaviours, incidence of sexually transmitted infections, or pregnancy" in "high income countries".

In February 2017, Journal of Adolescent Health found that A.O.U.M policies "reinforce harmful gender stereotypes" as well as fail to bring down teen pregnancy and STI rates.

Virginity pledges

Virginity pledges (or "abstinence pledge") are a written or oral promise that young people make to remain abstinent until marriage. Although often linked to religious abstinence-only programs, virginity pledges have recently become included in many secular abstinence-only programs as well.

A virginity pledge may look like this:

I, _____________, promise to abstain from sex until my wedding night. I want to reserve my sexual powers to give life and love for my future spouse and marriage. I will respect my gift of sexuality by keeping my mind and thoughts pure as I prepare for my true love. I commit to grow in character to learn to live love and freedom.

A purity ring can be a symbol of a virginity pledge.

A study done at Columbia University showed that, while many adolescents who take virginity pledges do choose to abstain from sexual activity, those who eventually break their pledge are at a higher risk for unsafe sex their first time than adolescents who did not take a virginity pledge at all. The study also showed that virginity pledges were most effective within a small group of pledgers in an at least partially nonnormative setting, meaning that if abstinence is not the norm, those taking a virginity pledge are more likely to adhere to it.

The National Longitudinal Survey of Youth has found that, while pledgers are more likely to abstain until marriage than non-pledgers – 99% of whom will have sex before marriage – 88% of the pledgers studied had vaginal intercourse before marriage. Out of those who pledge, there was a significant delay in first experience with vaginal intercourse, with an average delay of 18 months. However, people who took a virginity pledge were found to be less likely to have protected sex upon initiation and less likely to get STI tested if a concern arose.

Gender in sex education

Like all topics relating to sexuality, gender is a fundamental part of sexual education, and ideas of gender and sex are closely related in American culture. However, there is evidence of gendered messages within American school-based sex education that may lead to the continued existence of harmful stereotypes about gender and sexuality.

Abstinence-only

The Journal of Adolescent Health conducted a study entitled "Abstinence-Only-Until-Marriage: An Updated Review of U.S. Policies and Programs and Their Impact". This study found that abstinence-only sex education reinforces harmful gender stereotypes regarding female passivity and "rigid masculinity", both of which are associated with decreased use of condoms and birth control. Because of this association, the researchers concluded that these stereotypes "undermine adolescent sexual health". Research by Paul Dale Kleinert found that abstinence-only programs most often did not include information about sexual orientation or gender identity. Additional research by Jillian Grace Norwick conducted in 2016 found that in interviews with female college students who had abstinence-only sex education, participants commonly reported that they received messages about sexual "purity" aimed at girls.

Gender roles

A study from the University of Michigan conducted by Laina Bay-Cheng explored how school based sex education sometimes enforces traditional gender roles due to the "normalization" of heterosexual penile vaginal intercourse in monogamous relationships with socially accepted gender roles. The same programs fail to discuss the diversity of human sexual activities that do not fit inside the "norm". The study also suggested that these programs can portray girls as sexual victims and evoke such popular phrases as "boys will be boys" when discussing sexual assault and rape, leading students to believe that girls should be more responsible in order to avoid sexual assault. Other studies, such as Karin Martin's article "Gender Differences in the ABC's of the Birds and the Bees: What Mothers Teach Young Children About Sexuality and Reproduction" explore the different ways adolescents learn about sexuality from various sources, such as the media, religion, and family culture, specifically parents. This study asserts that gender roles, while introduced at very early ages, are emphasized and reinforced at adolescence. Paul Dale Kleinert also conducted research regarding this topic. His 2016 dissertation reviews the ways that school based sex education is rooted in societal structures such as gender roles, but the type of program, comprehensive, abstinence-only, or abstinence-plus, can greatly affect how strict and/or how traditional gender roles within sexuality are portrayed.

Sexuality in school culture

Another influence on the perception of student sexuality is school culture, as illustrated by Louisa Allen's study "Denying the Sexual Subject: Schools' Regulation of Student Sexuality". This study outlines how school culture can lead students to perceive themselves as having varying levels of sexual agency based on gender while also creating a normalized sexuality similar to that in the Bay-Cheng study. Regardless of the material included in the curricula of school based sex education, the general attitude surrounding sex within individual schools can influence the ways students think about their own sexuality and sexual experiences.

LGBT sex education

LGBT sex education includes the teachings of safe sex practices for people of all gender and sexual orientation identities, not just those participating in heterosexual sexual activities. Studies have shown that many schools do not offer such educational tracks today, possibly due to a controversy in the field of sex education regarding whether or not LGBT education should be integrated into course curriculum. The lack of information distributed regarding mentally and physcially healthy LGBT relationships can also be attributed to the ongoing stigma surrounding queerness in the US, especially as related to adolescents.

State policies

In the United States, 13 states require discussion of sexual orientation in sex education. Of those 13 states, 9 require discussion of sexual orientation to be inclusive, while 4 states require only negative information be presented regarding LGBT-related sexual orientation. Arizona provides HIV education with the condition that if and when it is taught, HIV education curriculum cannot promote a "homosexual lifestyle", or "portray homosexuality in a positive manner". Similarly, Oklahoma HIV education teaches, "among other behaviors, that 'homosexual activity' is considered to be 'responsible for contact with the AIDS virus.'"

On October 1, 2015, Governor of California Jerry Brown issued a statewide mandate for sexual health education. Known as the "California Healthy Young Act", the bill required that all sex ed curriculums used in public 7-12th grade classrooms contain accurate information as pertaining to gender and sexual orientation. Assembly Bill 329 also requires that the curriculum "affirmatively recognize that people have different sexual orientations." While it has been difficult for the state to guarantee that this bill is implemented effectively and evenly across schools, the bill has been met with little resistance by educators or parents.

Pro-LGBT Sex Education

In the United States, in public school programs where LGBT sex education is not a part of the sex education curriculum, LGBT students are more likely to engage in riskier sex, ultimately leading to higher rates of HIV/AIDS and other sexually transmitted infections, such as gonorrhea and chlamydia, as well as more reported cases of teenage pregnancy. This problem does not occur as frequently for LGBT students who are in enrolled in public schools with programs that cover LGBT sexual issues in their sex education courses. Additionally, LGBT students who do not receive specialized sex education are more likely to search online in order to seek additional resources in order to learn more about their sexuality or identity, which may not be safe or factual. Often, young LGBT students will learn about their sexualities from finding pornographic movies on the internet. The inclusion of LGBT curriculum in sex education courses has also been shown to decrease bullying of students who identify as LGBT in United States public schools.

Anti-LGBT Sex Education

The more conservative side who oppose LGBT inclusive sex education argue that it will force a sexuality onto children; however, research shows that inclusive education does not change sexual orientation, but it does reduce LGBT harassment in schools. Advocates against LGBT sex education might also say that this will promote sexual experiences with youth and premarital sex, but those factors occur in places with and without LGBT inclusive sex education curriculum, but lower pregnancy rates and sexually transmitted infection rates.

Controversy

Supporters of LGBT sex education argue that encompassing all gender and sexual identifications provides LGBT students with the health information pertinent to them, such as STD prevention for same-sex intimacy. Furthermore, these teachings could help prevent low self-esteem, depression, and bullying, as indicated through research. Opponents of LGBT-friendly sex education claim that teaching health topics in this way could be disrespectful to some religious beliefs and potentially inflict particular political views on students.

Sex education policies and access

Receipt of formal sex education has been found to correlate with important factors, such as age, income, race, location, and background.Cite error: A <ref> tag is missing the closing </ref> (see the help page).

Regional access

There are significant differences in the content of sexual education in different geographic regions of the U.S. Curriculums in the Northeast are less likely to give abstinence-only sex education as a method of pregnancy and STD prevention than curriculums in the South. This leads to reduced odds of education on a wide variety of topics and methods for students in those areas that teach abstinence-only education. States in the Midwest, South, and West are more likely than schools in the Northeast to teach about the ineffectiveness of non-natural birth control methods or just not cover them at all.

General policies

As of May 1, 2018:

  • 24 states mandate that sex education be provided.
  • 22 states (and the District of Columbia) mandate that sex and HIV education be provided.
  • 13 states require that, when provided, sex education be medically accurate.
  • 2 states ban the promotion of religion in sex education.
  • 8 states require that sex education cannot be biased against any race or ethnicity, and must be culturally appropriate and pertinent to the students' background.
  • 26 states (and the District of Columbia) require that age-appropriate information is provided in the sex education curriculum.
  • 18 states (and the District of Columbia) require that, when provided, sex education must include information on contraception.
    • Alabama, California, Colorado, Delaware, Hawaii, Illinois, Maine, Maryland, New Jersey, New Mexico, North Carolina, Oregon, Rhode Island, South Carolina, Vermont, Virginia, Washington, West Virginia, District of Columbia
  • 17 states require that, when provided, sex education covers sexual orientation in either an inclusive or negative way.
    • 10 states (and the District of Columbia) require an inclusive perspective on sexual orientation be given.
      • California, Colorado, Connecticut, Delaware, Iowa, New Jersey, New Mexico, Oregon, Rhode Island, Washington, District of Columbia
    • 7 states require that only negative information on sexual orientation be presented.
      • Alabama, Arizona, Florida, Illinois, South Carolina, Texas

Abstinence education

As of May 1, 2018:

37 states require abstinence education be provided.

  • 26 states require abstinence to be stressed.
    • Alabama, Arizona, Arkansas, Delaware, Florida, Georgia, Illinois, Indiana, Louisiana, Maine, Michigan, Mississippi, Missouri, New Jersey, North Carolina, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, Tennessee, Texas, Utah, Washington, Wisconsin
  • 12 states require abstinence to be covered.
    • California, Colorado, Hawaii, Kentucky, Maryland, Minnesota, Montana, New Mexico, North Dakota, Vermont, Virginia, West Virginia
  • 18 states require that instruction regarding the importance of waiting to engage in sexual relations until marriage be included.
    • Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, Mississippi, Missouri, North Carolina, Ohio, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin
    • 13 states require that discussion be included regarding potential negative outcomes of teen pregnancy
      • Alabama, Arizona, Florida, Georgia, Indiana, Kentucky, Michigan, Mississippi, Missouri, Ohio, Tennessee, Texas, West Virginia

Parental role

As of May 1, 2018:

States vary in policy regarding parental role in sex education; some states require parental consent to teach certain aspects of the sex/HIV education curriculum while others require that parents are active participants in the education.

  • 38 states (and the District of Columbia) require the inclusion of parents in sex and/or HIV education.
  • 22 states (and the District of Columbia) require that parents are notified that sex and/or HIV education is being provided.
  • 36 states (and the District of Columbia) provide parents with the opportunity to prevent their child from receiving sex/HIV education by removing them from the curriculum.
    • Alabama, California, Colorado, Connecticut, District Of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin
    • In Arizona, New York and Pennsylvania, parents can have their child Opt-out of HIV education
  • 3 states require parental consent prior to allowing students to participate in sex and/or HIV education
    • Arizona, Nevada, Utah

Teaching healthy sexuality

Some sex education curriculums include instruction regarding healthy practices for relationships and sexuality. This instruction can vary from a broad range of topics, such as communication strategies to maintaining sexual health.

As of May 1, 2018:

  • 28 states (and the District of Columbia) require that when sex education is provided it includes information regarding healthy "Life Skills", including; healthy decision making, healthy sexuality (including avoiding/preventing coerced sex), and family communication.
    • Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Hawaii, Kentucky, Illinois, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, New Jersey, New Mexico, North Carolina, Oregon, Rhode Island, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia
  • 22 states (and the District of Columbia) require that sex education curriculum discuss skills and information to prevent coerced sex.
    • Alabama, Arizona, Arkansas, Colorado, Delaware, District of Columbia, Illinois, Maryland, Michigan, Mississippi, Missouri, New Hampshire, New Mexico, North Carolina, Oregon, Rhode Island, Tennessee, Texas, Utah, Vermont, Virginia, West Virginia
  • 22 states (and the District of Columbia) require that sex education curriculum includes discussion of skills for healthy sexuality.
  • 11 states require that sex education curriculum include communication skills for teens, and instruction for discussing sex and sexuality with family members (emphasizing communication with parents).
    • California, Colorado, Maine, New Mexico, North Carolina, Oregon, Tennessee, Utah, Vermont, Virginia, Washington

HIV education

As of May 1, 2018:

  • 34 states (and the District of Columbia) mandate HIV education
    • Alabama, California, Connecticut, Delaware, District of Columbia, Georgia, Hawaii, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Michigan, Minnesota, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Washington, West Virginia, Wisconsin
  • 20 states require that, when provided, HIV education must include information about condoms and other forms of contraception
  • 39 states require that HIV education must include abstinence
    • 27 states require stressing abstinence
    • 12 states require discussing abstinence

Influence of wealth on sex education

Teens from non-white, low-income families are more likely to receive abstinence-only sex education, according to the National Survey of Family and Growth. Teens with intact families are also more likely to receive comprehensive sex education than those living with a single parent. Disadvantaged youth are the shown to be the least likely social strata to benefit from formal sex education programs.

See also

Medroxyprogesterone acetate

From Wikipedia, the free encyclopedia

https://en.wikipedia.org/wiki/Medroxyprogesterone_acetate 

Medroxyprogesterone acetate
Medroxyprogesterone acetate.svg
Medroxyprogesterone acetate molecule ball.png
Clinical data
Pronunciation/mɛˌdrɒksiprˈɛstərn ˈæsɪtt/ me-DROKS-ee-proh-JES-tər-ohn ASS-i-tayt
Trade namesProvera, Depo-Provera, Depo-SubQ Provera 104, Curretab, Cycrin, Farlutal, Gestapuran, Perlutex, Veramix, others
Other namesMPA; DMPA; Methylhydroxyprogesterone acetate; Methylacetoxyprogesterone; MAP; Methypregnone; Metipregnone; 6α-Methyl-17α-hydroxyprogesterone acetate; 6α-Methyl-17α-acetoxyprogesterone; 6α-Methyl-17α-hydroxypregn-4-ene-3,20-dione acetate; NSC-26386
AHFS/Drugs.comMonograph
MedlinePlusa604039
Routes of
administration
By mouth, sublingual, intramuscular injection, subcutaneous injection
Drug classProgestogen; Progestin; Progestogen ester; Antigonadotropin; Steroidal antiandrogen
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • In general: ℞ (Prescription only)
Pharmacokinetic data
BioavailabilityBy mouth: ~100%
Protein binding88% (to albumin)
MetabolismLiver (hydroxylation (CYP3A4), reduction, conjugation)
Elimination half-lifeBy mouth: 12–33 hours
IM (aq. susp.): ~50 days
SC (aq. susp.): ~40 days
ExcretionUrine (as conjugates)
Identifiers

CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.000.689 Edit this at Wikidata
Chemical and physical data
FormulaC24H34O4
Molar mass386.532 g·mol−1
3D model (JSmol)
Melting point207 to 209 °C (405 to 408 °F)

Medroxyprogesterone acetate (MPA), also known as depot medroxyprogesterone acetate (DMPA) in injectable form and sold under the brand name Depo-Provera among others, is a hormonal medication of the progestin type. It is used as a method of birth control and as a part of menopausal hormone therapy. It is also used to treat endometriosis, abnormal uterine bleeding, abnormal sexuality in males, and certain types of cancer. The medication is available both alone and in combination with an estrogen. It is taken by mouth, used under the tongue, or by injection into a muscle or fat.

Common side effects include menstrual disturbances such as absence of periods, abdominal pain, and headaches. More serious side effects include bone loss, blood clots, allergic reactions, and liver problems. Use is not recommended during pregnancy as it may harm the baby. MPA is an artificial progestogen, and as such activates the progesterone receptor, the biological target of progesterone. It also has weak glucocorticoid activity and very weak androgenic activity but no other important hormonal activity. Due to its progestogenic activity, MPA decreases the body's release of gonadotropins and can suppress sex hormone levels. It works as a form of birth control by preventing ovulation.

MPA was discovered in 1956 and was introduced for medical use in the United States in 1959. It is on the World Health Organization's List of Essential Medicines. MPA is the most widely used progestin in menopausal hormone therapy and in progestogen-only birth control. DMPA is approved for use as a form of long-acting birth control in more than 100 countries. In 2018, it was the 202nd most commonly prescribed medication in the United States, with more than 2 million prescriptions.

Medical uses

The most common use of MPA is in the form of DMPA as a long-acting progestogen-only injectable contraceptive to prevent pregnancy in women. It is an extremely effective contraceptive when used with relatively high doses to prevent ovulation. MPA is also used in combination with an estrogen in menopausal hormone therapy in postmenopausal women to treat and prevent menopausal symptoms such as hot flashes, vaginal atrophy, and osteoporosis. It is used in menopausal hormone therapy specifically to prevent endometrial hyperplasia and cancer that would otherwise be induced by prolonged unopposed estrogen therapy in women with intact uteruses. In addition to contraception and menopausal hormone therapy, MPA is used in the treatment of gynecological and menstrual disorders such as dysmenorrhea, amenorrhea, and endometriosis. Along with other progestins, MPA was developed to allow for oral progestogen therapy, as progesterone (the progestogen hormone made by the human body) could not be taken orally for many decades before the process of micronization was developed and became feasible in terms of pharmaceutical manufacturing.

DMPA reduces sex drive in men and is used as a form of chemical castration to control inappropriate or unwanted sexual behavior in those with paraphilias or hypersexuality, including in convicted sex offenders. DMPA has also been used to treat benign prostatic hyperplasia, as a palliative appetite stimulant for cancer patients, and at high doses (800 mg per day) to treat certain hormone-dependent cancers including endometrial cancer, renal cancer, and breast cancer. MPA has also been prescribed in feminizing hormone therapy for transgender women due to its progestogenic and functional antiandrogenic effects. It has been used to delay puberty in children with precocious puberty but is not satisfactory for this purpose as it is not able to completely suppress puberty. DMPA at high doses has been reported to be definitively effective in the treatment of hirsutism as well.

Though not used as a treatment for epilepsy, MPA has been found to reduce the frequency of seizures and does not interact with antiepileptic medications. MPA does not interfere with blood clotting and appears to improve blood parameters for women with sickle cell anemia. Similarly, MPA does not appear to affect liver metabolism, and may improve primary biliary cirrhosis and chronic active hepatitis. Women taking MPA may experience spotting shortly after starting the medication but is not usually serious enough to require medical intervention. With longer use amenorrhea (absence of menstruation) can occur as can irregular menstruation which is a major source of dissatisfaction, though both can result in improvements with iron deficiency and risk of pelvic inflammatory disease and often do not result in discontinuation of the medication.

Birth control

Depot medroxyprogesterone acetate (DMPA)
Prikpil.JPG
Background
TypeHormonal
First use1969
Trade namesDepo-Provera, Depo-SubQ Provera 104, others
AHFS/Drugs.comdepo-provera
Failure rates (first year)
Perfect use0.2%
Typical use6%
Usage
Duration effect3 months
(12–14 weeks)
Reversibility3–18 months
User remindersMaximum interval is just under 3 months
Clinic review12 weeks
Advantages and disadvantages
STI protectionNo
Period disadvantagesEspecially in first injection may be frequent spotting
Period advantagesUsually no periods from 2nd injection
BenefitsEspecially good if poor pill compliance.
Reduced endometrial cancer risk.
RisksReduced bone density, which may reverse after discontinuation
Medical notes
For those intending to start family, suggest switch 6 months prior to alternative method (e.g. POP) allowing more reliable return fertility.

DMPA, under brand names such as Depo-Provera and Depo-SubQ Provera 104, is used in hormonal birth control as a long-lasting progestogen-only injectable contraceptive to prevent pregnancy in women. It is given by intramuscular or subcutaneous injection and forms a long-lasting depot, from which it is slowly released over a period of several months. It takes one week to take effect if given after the first five days of the period cycle, and is effective immediately if given during the first five days of the period cycle. Estimates of first-year failure rates are about 0.3%. MPA is effective in preventing pregnancy, but offers no protection against sexually transmitted infections (STIs).

Effectiveness

Trussell's estimated perfect use first-year failure rate for DMPA as the average of failure rates in seven clinical trials at 0.3%. It was considered perfect use because the clinical trials measured efficacy during actual use of DMPA defined as being no longer than 14 or 15 weeks after an injection (i.e., no more than 1 or 2 weeks late for a next injection).

Prior to 2004, Trussell's typical use failure rate for DMPA was the same as his perfect use failure rate: 0.3%.

  • DMPA estimated typical use first-year failure rate = 0.3% in:
    • Contraceptive Technology, 16th revised edition (1994)
    • Contraceptive Technology, 17th revised edition (1998)
      • Adopted in 1998 by the FDA for its current Uniform Contraceptive Labeling guidance

In 2004, using the 1995 NSFG failure rate, Trussell increased (by 10 times) his typical use failure rate for DMPA from 0.3% to 3%.

  • DMPA estimated typical use first-year failure rate = 3% in:
    • Contraceptive Technology, 18th revised edition (2004)
    • Contraceptive Technology, 19th revised edition (2007)

Trussell did not use 1995 NSFG failure rates as typical use failure rates for the other two then newly available long-acting contraceptives, the Norplant implant (2.3%) and the ParaGard copper T 380A IUD (3.7%), which were (as with DMPA) an order of magnitude higher than in clinical trials. Since Norplant and ParaGard allow no scope for user error, their much higher 1995 NSFG failure rates were attributed by Trussell to contraceptive overreporting at the time of a conception leading to a live birth.

Advantages

DMPA has a number of advantages and benefits:

The United Kingdom Department of Health has actively promoted Long Acting Reversible Contraceptive use since 2008, particularly for young people; following on from the October 2005 National Institute for Health and Clinical Excellence guidelines. Giving advice on these methods of contraception has been included in the 2009 Quality and Outcomes Framework "good practice" for primary care.

Comparison

Proponents of bioidentical hormone therapy believe that progesterone offers fewer side effects and improved quality of life compared to MPA. The evidence for this view has been questioned; MPA is better absorbed when taken by mouth, with a much longer elimination half-life leading to more stable blood levels though it may lead to greater breast tenderness and more sporadic vaginal bleeding. The two compounds do not differentiate in their ability to suppress endometrial hyperplasia, nor does either increase the risk of pulmonary embolism. The two medications have not been adequately compared in direct tests to clear conclusions about safety and superiority.

Available forms

MPA is available alone in the form of 2.5, 5, and 10 mg oral tablets, as a 150 mg/mL (1 mL) or 400 mg/mL (2.5 mL) microcrystalline aqueous suspension for intramuscular injection, and as a 104 mg (0.65 mL of 160 mg/mL) microcrystalline aqueous suspension for subcutaneous injection. It has also been marketed in the form of 100, 200, 250, 400, and 500 mg oral tablets; 500 and 1,000 mg oral suspensions; and as a 50 mg/mL microcrystalline aqueous suspension for intramuscular injection. A 100 mg/mL microcrystalline aqueous suspension for intramuscular injection was previously available as well. In addition to single-drug formulations, MPA is available in the form of oral tablets in combination with conjugated estrogens (CEEs), estradiol, and estradiol valerate for use in menopausal hormone therapy, and is available in combination with estradiol cypionate in a microcrystalline aqueous suspension as a combined injectable contraceptive.

Depo-Provera is the brand name for a 150 mg microcrystalline aqueous suspension of DMPA that is administered by intramuscular injection. The shot must be injected into thigh, buttock, or deltoid muscle four times a year (every 11 to 13 weeks), and provides pregnancy protection instantaneously after the first injection. Depo-subQ Provera 104 is a variation of the original intramuscular DMPA that is instead a 104 mg microcrystalline dose in aqueous suspension administered by subcutaneous injection. It contains 69% of the MPA found in the original intramuscular DMPA formulation. It can be injected using a smaller injection needle inserting the medication just below the skin, instead of into the muscle, in either the abdomen or thigh. This subcutaneous injection claims to reduce the side effects of DMPA while still maintaining all the same benefits of the original intramuscular DMPA.

Contraindications

MPA is not usually recommended because of unacceptable health risk or because it is not indicated in the following cases:

Conditions where the theoretical or proven risks usually outweigh the advantages of using DMPA:

Conditions which represent an unacceptable health risk if DMPA is used:

Conditions where use is not indicated and should not be initiated:

MPA is not recommended for use prior to menarche or before or during recovery from surgery.

Side effects

In women, the most common adverse effects of MPA are acne, changes in menstrual flow, drowsiness, and can cause birth defects if taken by pregnant women. Other common side effects include breast tenderness, increased facial hair, decreased scalp hair, difficulty falling or remaining asleep, stomach pain, and weight loss or gain. Lowered libido has been reported as a side effect of MPA in women. DMPA can affect menstrual bleeding. After a year of use, 55% of women experience amenorrhea (missed periods); after 2 years, the rate rises to 68%. In the first months of use "irregular or unpredictable bleeding or spotting, or, rarely, heavy or continuous bleeding" was reported. MPA does not appear to be associated with vitamin B12 deficiency. Data on weight gain with DMPA likewise are inconsistent.

At high doses for the treatment of breast cancer, MPA can cause weight gain and can worsen diabetes mellitus and edema (particularly of the face). Adverse effects peak at five weeks, and are reduced with lower doses. Less frequent effects may include thrombosis (though it is not clear if this is truly a risk, it cannot be ruled out), painful urination, headache, nausea, and vomiting. When used as a form of androgen deprivation therapy in men, more frequent complaints include reduced libido, impotence, reduced ejaculate volume, and within three days, chemical castration. At extremely high doses (used to treat cancer, not for contraception) MPA may cause adrenal suppression and may interfere with carbohydrate metabolism, but does not cause diabetes.

When used as a form of injected birth control, there is a delayed return of fertility. The average return to fertility is 9 to 10 months after the last injection, taking longer for overweight or obese women. By 18 months after the last injection, fertility is the same as that in former users of other contraceptive methods. Fetuses exposed to progestogens have demonstrated higher rates of genital abnormalities, low birth weight, and increased ectopic pregnancy particularly when MPA is used as an injected form of long-term birth control. A study of accidental pregnancies among poor women in Thailand found that infants who had been exposed to DMPA during pregnancy had a higher risk of low birth weight and an 80% greater-than-usual chance of dying in the first year of life.

Mood changes

There have been concerns about a possible risk of depression and mood changes with progestins like MPA, and this has led to reluctance of some clinicians and women to use them. However, contrary to widely-held beliefs, most research suggests that progestins do not cause adverse psychological effects such as depression or anxiety. A 2018 systematic review of the relationship between progestin-based contraception and depression included three large studies of DMPA and reported no association between DMPA and depression. According to a 2003 review of DMPA, the majority of published clinical studies indicate that DMPA is not associated with depression, and the overall data support the notion that the medication does not significantly affect mood.

In the largest study to have assessed the relationship between MPA and depression to date, in which over 3,900 women were treated with DMPA for up to 7 years, the incidence of depression was infrequent at 1.5% and the discontinuation rate due to depression was 0.5%. This study did not include baseline data on depression, and due to the incidence of depression in the study, the FDA required package labeling for DMPA stating that women with depression should be observed carefully and that DMPA should be discontinued if depression recurs. A subsequent study of 495 women treated with DMPA over the course of 1 year found that the mean depression score slightly decreased in the whole group of continuing users from 7.4 to 6.7 (by 9.5%) and decreased in the quintile of that group with the highest depression scores at baseline from 15.4 to 9.5 (by 38%). Based on the results of this study and others, a consensus began emerging that DMPA does not in fact increase the risk of depression nor worsen the severity of pre-existing depression.

Similarly to the case of DMPA for hormonal contraception, the Heart and Estrogen/Progestin Replacement Study (HERS), a study of 2,763 postmenopausal women treated with 0.625 mg/day oral CEEs plus 2.5 mg/day oral MPA or placebo for 36 months as a method of menopausal hormone therapy, found no change in depressive symptoms. However, some small studies have reported that progestins like MPA might counteract beneficial effects of estrogens against depression.

Long-term effects

The Women's Health Initiative investigated the use of a combination of oral CEEs and MPA compared to placebo. The study was prematurely terminated when previously unexpected risks were discovered, specifically the finding that though the all-cause mortality was not affected by the hormone therapy, the benefits of menopausal hormone therapy (reduced risk of hip fracture, colorectal and endometrial cancer and all other causes of death) were offset by increased risk of coronary heart disease, breast cancer, strokes and pulmonary embolism.

When combined with CEEs, MPA has been associated with an increased risk of breast cancer, dementia, and thrombus in the eye. In combination with estrogens in general, MPA may increase the risk of cardiovascular disease, with a stronger association when used by postmenopausal women also taking CEEs. It was because of these unexpected interactions that the Women's Health Initiative study was ended early due to the extra risks of menopausal hormone therapy, resulting in a dramatic decrease in both new and renewal prescriptions for hormone therapy.

Long-term studies of users of DMPA have found slight or no increased overall risk of breast cancer. However, the study population did show a slightly increased risk of breast cancer in recent users (DMPA use in the last four years) under age 35, similar to that seen with the use of combined oral contraceptive pills.

Blood clots

DMPA has been associated in multiple studies with a higher risk of venous thromboembolism (VTE) when used as a form of progestogen-only birth control in premenopausal women. The increase in incidence of VTE ranges from 2.2-fold to 3.6-fold. Elevated risk of VTE with DMPA is unexpected, as DMPA has little or no effect on coagulation and fibrinolytic factors, and progestogens by themselves normally do not increase the risk of thrombosis. It has been argued that the higher incidence with DMPA has reflected preferential prescription of DMPA to women considered to be at an increased risk of VTE. Alternatively, it is possible that MPA may be an exception among progestins in terms of VTE risk. A 2018 meta-analysis reported that MPA was associated with a 2.8-fold higher risk of VTE than other progestins. It is possible that the glucocorticoid activity of MPA may increase the risk of VTE.

Bone density

DMPA may cause reduced bone density in premenopausal women and in men when used without an estrogen, particularly at high doses, though this appears to be reversible to a normal level even after years of use.

On 17 November 2004, the United States Food and Drug Administration put a black box warning on the label, indicating that there were potential adverse effects of loss of bone mineral density. While it causes temporary bone loss, most women fully regain their bone density after discontinuing use. The World Health Organization (WHO) recommends that the use not be restricted. The American College of Obstetricians and Gynecologists notes that the potential adverse effects on BMD be balanced against the known negative effects of unintended pregnancy using other birth control methods or no method, particularly among adolescents.

Three studies have suggested that bone loss is reversible after the discontinuation of DMPA. Other studies have suggested that the effect of DMPA use on postmenopausal bone density is minimal, perhaps because DMPA users experience less bone loss at menopause. Use after peak bone mass is associated with increased bone turnover but no decrease in bone mineral density.

The FDA recommends that DMPA not be used for longer than 2 years, unless there is no viable alternative method of contraception, due to concerns over bone loss. However, a 2008 Committee Opinion from the American Congress of Obstetricians and Gynecologists (ACOG) advises healthcare providers that concerns about bone mineral density loss should neither prevent the prescription of or continuation of DMPA beyond 2 years of use.

HIV risk

There is uncertainty regarding the risk of HIV acquisition among DMPA users; some observational studies suggest an increased risk of HIV acquisition among women using DMPA, while others do not. The World Health Organization issued statements in February 2012 and July 2014 saying the data did not warrant changing their recommendation of no restriction – Medical Eligibility for Contraception (MEC) category 1 – on the use of DMPA in women at high risk for HIV. Two meta-analyses of observational studies in sub-Saharan Africa were published in January 2015. They found a 1.4- to 1.5-fold increase risk of HIV acquisition for DMPA users relative to no hormonal contraceptive use. In January 2015, the Faculty of Sexual & Reproductive Healthcare of the Royal College of Obstetricians and Gynaecologists issued a statement reaffirming that there is no reason to advise against use of DMPA in the United Kingdom even for women at 'high risk' of HIV infection. A systematic review and meta-analysis of risk of HIV infection in DMPA users published in fall of 2015 stated that "the epidemiological and biological evidence now make a compelling case that DMPA adds significantly to the risk of male-to-female HIV transmission." In 2019, a randomized controlled trial found no significant association between DMPA use and HIV.

Breastfeeding

MPA may be used by breastfeeding mothers. Heavy bleeding is possible if given in the immediate postpartum time and is best delayed until six weeks after birth. It may be used within five days if not breast feeding. While a study showed "no significant difference in birth weights or incidence of birth defects" and "no significant alternation of immunity to infectious disease caused by breast milk containing DMPA", a subgroup of babies whose mothers started DMPA at 2 days postpartum had a 75% higher incidence of doctor visits for infectious diseases during their first year of life.

A larger study with longer follow-up concluded that "use of DMPA during pregnancy or breastfeeding does not adversely affect the long-term growth and development of children". This study also noted that "children with DMPA exposure during pregnancy and lactation had an increased risk of suboptimal growth in height," but that "after adjustment for socioeconomic factors by multiple logistic regression, there was no increased risk of impaired growth among the DMPA-exposed children." The study also noted that effects of DMPA exposure on puberty require further study, as so few children over the age of 10 were observed.

Overdose

MPA has been studied at "massive" dosages of up to 5,000 mg per day orally and 2,000 mg per day via intramuscular injection, without major tolerability or safety issues described. Overdose is not described in the Food and Drug Administration (FDA) product labels for injected MPA (Depo-Provera or Depo-SubQ Provera 104). In the FDA product label for oral MPA (Provera), it is stated that overdose of an estrogen and progestin may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness, fatigue, and withdrawal bleeding. According to the label, treatment of overdose should consist of discontinuation of MPA therapy and symptomatic care.

Interactions

MPA increases the risk of breast cancer, dementia, and thrombus when used in combination with CEEs to treat menopausal symptoms. When used as a contraceptive, MPA does not generally interact with other medications. The combination of MPA with aminoglutethimide to treat metastases from breast cancer has been associated with an increase in depression. St John's wort may decrease the effectiveness of MPA as a contraceptive due to acceleration of its metabolism.

Pharmacology

Pharmacodynamics

MPA acts as an agonist of the progesterone, androgen, and glucocorticoid receptors (PR, AR, and GR, respectively), activating these receptors with EC50 values of approximately 0.01 nM, 1 nM, and 10 nM, respectively. It has negligible affinity for the estrogen receptor. The medication has relatively high affinity for the mineralocorticoid receptor, but in spite of this, it has no mineralocorticoid or antimineralocorticoid activity. The intrinsic activities of MPA in activating the PR and the AR have been reported to be at least equivalent to those of progesterone and dihydrotestosterone (DHT), respectively, indicating that it is a full agonist of these receptors.

Progestogenic activity

MPA is a potent agonist of the progesterone receptor with similar affinity and efficacy relative to progesterone. While both MPA and its deacetylated analogue medroxyprogesterone bind to and agonize the PR, MPA has approximately 100-fold higher binding affinity and transactivation potency in comparison. As such, unlike MPA, medroxyprogesterone is not used clinically, though it has seen some use in veterinary medicine. The oral dosage of MPA required to inhibit ovulation (i.e., the effective contraceptive dosage) is 10 mg/day, whereas 5 mg/day was not sufficient to inhibit ovulation in all women. In accordance, the dosage of MPA used in oral contraceptives in the past was 10 mg per tablet. For comparison to MPA, the dosage of progesterone required to inhibit ovulation is 300 mg/day, whereas that of the 19-nortestosterone derivatives norethisterone and norethisterone acetate is only 0.4 to 0.5 mg/day.

The mechanism of action of progestogen-only contraceptives like DMPA depends on the progestogen activity and dose. High-dose progestogen-only contraceptives, such as DMPA, inhibit follicular development and prevent ovulation as their primary mechanism of action. The progestogen decreases the pulse frequency of gonadotropin-releasing hormone (GnRH) release by the hypothalamus, which decreases the release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) by the anterior pituitary. Decreased levels of FSH inhibit follicular development, preventing an increase in estradiol levels. Progestogen negative feedback and the lack of estrogen positive feedback on LH release prevent a LH surge. Inhibition of follicular development and the absence of a LH surge prevent ovulation. A secondary mechanism of action of all progestogen-containing contraceptives is inhibition of sperm penetration by changes in the cervical mucus. Inhibition of ovarian function during DMPA use causes the endometrium to become thin and atrophic. These changes in the endometrium could, theoretically, prevent implantation. However, because DMPA is highly effective in inhibiting ovulation and sperm penetration, the possibility of fertilization is negligible. No available data support prevention of implantation as a mechanism of action of DMPA.

MPA and related steroids at the progesterone receptor
Oral potencies of MPA and related steroids
Parenteral potencies and durations of progestogens
Compound Form Dose for specific uses (mg) DOA
TFD POICD CICD
Algestone acetophenide Oil soln. - 75–150 14–32 d
Gestonorone caproate Oil soln. 25–50 8–13 d
Hydroxyprogest. acetate Aq. susp. 350 9–16 d
Hydroxyprogest. caproate Oil soln. 250–500 250–500 5–21 d
Medroxyprog. acetate Aq. susp. 50–100 150 25 14–50+ d
Megestrol acetate Aq. susp. - 25 >14 d
Norethisterone enanthate Oil soln. 100–200 200 50 11–52 d
Progesterone Oil soln. 200 2–6 d
Aq. soln. ? 1–2 d
Aq. susp. 50–200 7–14 d

Antigonadotropic and anticorticotropic effects

MPA suppresses the hypothalamic–pituitary–adrenal (HPA) and hypothalamic–pituitary–gonadal (HPG) axes at sufficient dosages, resulting decreased levels of gonadotropins, androgens, estrogens, adrenocorticotropic hormone (ACTH), and cortisol, as well as levels of sex hormone-binding globulin (SHBG). There is evidence that the suppressive effects of MPA on the HPG axis are mediated by activation of both the PR and the AR in the pituitary gland. Due to its effects on androgen levels, MPA can produce strong functional antiandrogenic effects, and is used in the treatment of androgen-dependent conditions such as precocious puberty in boys and hypersexuality in men. In addition, since the medication suppresses estrogen levels as well, MPA can produce strong functional antiestrogenic effects similarly, and has been used to treat estrogen-dependent conditions such as precocious puberty in girls and endometriosis in women. Due to low estrogen levels, the use of MPA without an estrogen poses a risk of decreased bone mineral density and other symptoms of estrogen deficiency.

Oral MPA has been found to suppress testosterone levels in men by about 30% (from 831 ng/dL to 585 ng/dL) at a dosage of 20 mg/day, by about 45 to 75% (average 60%; to 150–400 ng/dL) at a dosage of 60 mg/day, and by about 70 to 75% (from 832–862 ng/dL to 214–251 ng/dL) at a dosage of 100 mg/day. Dosages of oral MPA of 2.5 to 30 mg/day in combination with estrogens have been used to help suppress testosterone levels in transgender women. Very high dosages of intramuscular MPA of 150 to 500 mg per week (but up to 900 mg per week) can suppress testosterone levels to less than 100 ng/dL. The typical initial dose of intramuscular MPA for testosterone suppression in men with paraphilias is 400 or 500 mg per week.

Androgenic activity

MPA is a potent full agonist of the AR. Its activation of the AR may play an important and major role in its antigonadotropic effects and in its beneficial effects against breast cancer. However, although MPA may produce androgenic side effects such as acne and hirsutism in some women, it rarely does so, and when such symptoms occur, they tend to be mild, regardless of the dosage used. In fact, likely due to its suppressive actions on androgen levels, it has been reported that MPA is generally highly effective in improving pre-existing symptoms of hirsutism in women with the condition. Moreover, MPA rarely causes any androgenic effects in children with precocious puberty, even at very high doses. The reason for the general lack of virilizing effects with MPA, despite it binding to and activating the AR with high affinity and this action potentially playing an important role in many of its physiological and therapeutic effects, is not entirely clear. However, MPA has been found to interact with the AR differently compared to other agonists of the receptor such as dihydrotestosterone (DHT). The result of this difference appears to be that MPA binds to the AR with a similar affinity and intrinsic activity to that of DHT, but requires about 100-fold higher concentrations for a comparable induction of gene transcription, while at the same time not antagonizing the transcriptional activity of normal androgens like DHT at any concentration. Thus, this may explain the low propensity of MPA for producing androgenic side effects.

MPA shows weak androgenic effects on liver protein synthesis, similarly to other weakly androgenic progestins like megestrol acetate and 19-nortestosterone derivatives. While it does not antagonize estrogen-induced increases in levels of triglycerides and HDL cholesterol, DMPA every other week may decrease levels of HDL cholesterol. In addition, MPA has been found to suppress sex hormone-binding globulin (SHBG) production by the liver. At a dosage of 10 mg/day oral MPA, it has been found to decrease circulating SHBG levels by 14 to 18% in women taking 4 mg/day oral estradiol valerate. Conversely, in a study that combined 2.5 mg/day oral MPA with various oral estrogens, no influence of MPA on estrogen-induced increases in SHBG levels was discerned. In another, higher-dose study, SHBG levels were lower by 59% in a group of women treated with 50 mg/day oral MPA alone relative to an untreated control group of women. In a massive-dose study of oral MPA (1,000 mg/day), the medication decreased SHBG levels by about 80%.

Unlike the related steroids megestrol acetate and cyproterone acetate, MPA is not an antagonist of the AR and does not have direct antiandrogenic activity. As such, although MPA is sometimes described as an antiandrogen, it is not a "true" antiandrogen (i.e., AR antagonist).

Glucocorticoid activity

As an agonist of the GR, MPA has glucocorticoid activity, and as a result can cause symptoms of Cushing's syndrome, steroid diabetes, and adrenal insufficiency at sufficiently high doses. It has been suggested that the glucocorticoid activity of MPA may contribute to bone loss. The glucocorticoid activity of MPA may also result in an upregulation of the thrombin receptor in blood vessel walls, which may contribute to procoagulant effects of MPA and risk of venous thromboembolism and atherosclerosis. The relative glucocorticoid activity of MPA is among the highest of the clinically used progestins.

Glucocorticoid activity of selected steroids in vitro
Steroid Class TR ()a GR (%)b
Dexamethasone Corticosteroid ++ 100
Ethinylestradiol Estrogen 0
Etonogestrel Progestin + 14
Gestodene Progestin + 27
Levonorgestrel Progestin 1
Medroxyprogesterone acetate Progestin + 29
Norethisterone Progestin 0
Norgestimate Progestin 1
Progesterone Progestogen + 10
Footnotes: a = Thrombin receptor (TR) upregulation (↑) in vascular smooth muscle cells (VSMCs). b = RBA (%) for the glucocorticoid receptor (GR). Strength: – = No effect. + = Pronounced effect. ++ = Strong effect. 

Steroidogenesis inhibition

MPA has been found to act as a competitive inhibitor of rat 3α-hydroxysteroid dehydrogenase (3α-HSD). This enzyme is essential for the transformation of progesterone, deoxycorticosterone, and DHT into inhibitory neurosteroids such as allopregnanolone, THDOC, and 3α-androstanediol, respectively. MPA has been described as very potent in its inhibition of rat 3α-HSD, with an IC50 of 0.2 μM and a Ki (in rat testicular homogenates) of 0.42 μM. However, inhibition of 3α-HSD by MPA does not appear to have been confirmed using human proteins yet, and the concentrations required with rat proteins are far above typical human therapeutic concentrations.

MPA has been identified as a competitive inhibitor of human 3β-hydroxysteroid dehydrogenase/Δ5-4 isomerase II (3β-HSD II). This enzyme is essential for the biosynthesis of sex steroids and corticosteroids. The Ki of MPA for inhibition of 3β-HSD II is 3.0 μM, and this concentration is reportedly near the circulating levels of the medication that are achieved by very high therapeutic dosages of MPA of 5 to 20 mg/kg/day (dosages of 300 to 1,200 mg/day for a 60 kg (132 lb) person). Aside from 3β-HSD II, other human steroidogenic enzymes, including cholesterol side-chain cleavage enzyme (P450scc/CYP11A1) and 17α-hydroxylase/17,20-lyase (CYP17A1), were not found to be inhibited by MPA. MPA has been found to be effective in the treatment of gonadotropin-independent precocious puberty and in breast cancer in postmenopausal women at high dosages, and inhibition of 3β-HSD II could be responsible for its effectiveness in these conditions.

GABAA receptor allosteric modulation

Progesterone, via transformation into neurosteroids such as 5α-dihydroprogesterone, 5β-dihydroprogesterone, allopregnanolone, and pregnanolone (catalyzed by the enzymes 5α- and 5β-reductase and 3α- and 3β-HSD), is a positive allosteric modulator of the GABAA receptor, and is associated with a variety of effects mediated by this property including dizziness, sedation, hypnotic states, mood changes, anxiolysis, and cognitive/memory impairment, as well as effectiveness as an anticonvulsant in the treatment of catamenial epilepsy. It has also been found to produce anesthesia via this action in animals when administered at sufficiently high dosages. MPA was found to significantly reduce seizure incidence when added to existing anticonvulsant regimens in 11 of 14 women with uncontrolled epilepsy, and has also been reported to induce anesthesia in animals, raising the possibility that it might modulate the GABAA receptor similarly to progesterone.

MPA shares some of the same metabolic routes of progesterone and, analogously, can be transformed into metabolites such as 5α-dihydro-MPA (DHMPA) and 3α,5α-tetrahydro-MPA (THMPA). However, unlike the reduced metabolites of progesterone, DHMPA and THMPA have been found not to modulate the GABAA receptor. Conversely, unlike progesterone, MPA itself actually modulates the GABAA receptor, although notably not at the neurosteroid binding site. However, rather than act as a potentiator of the receptor, MPA appears to act as a negative allosteric modulator. Whereas the reduced metabolites of progesterone enhance binding of the benzodiazepine flunitrazepam to the GABAA receptor in vitro, MPA can partially inhibit the binding of flunitrazepam by up to 40% with half-maximal inhibition at 1 μM. However, the concentrations of MPA required for inhibition are high relative to therapeutic concentrations, and hence, this action is probably of little or no clinical relevance. The lack of potentiation of the GABAA receptor by MPA or its metabolites is surprising in consideration of the apparent anticonvulsant and anesthetic effects of MPA described above, and they remain unexplained.

Clinical studies using massive dosages of up to 5,000 mg/day oral MPA and 2,000 mg/day intramuscular MPA for 30 days in women with advanced breast cancer have reported "no relevant side effects", which suggests that MPA has no meaningful direct action on the GABAA receptor in humans even at extremely high dosages.

Appetite stimulation

Although MPA and the closely related medication megestrol acetate are effective appetite stimulants at very high dosages, the mechanism of action of their beneficial effects on appetite is not entirely clear. However, glucocorticoid, cytokine, and possibly anabolic-related mechanisms are all thought to possibly be involved, and a number of downstream changes have been implicated, including stimulation of the release of neuropeptide Y in the hypothalamus, modulation of calcium channels in the ventromedial hypothalamus, and inhibition of the secretion of proinflammatory cytokines including IL-1α, IL-1β, IL-6, and TNF-α, actions that have all been linked to an increase in appetite.

Other activity

MPA weakly stimulates the proliferation of MCF-7 breast cancer cells in vitro, an action that is independent of the classical PRs and is instead mediated via the progesterone receptor membrane component-1 (PGRMC1). Certain other progestins are also active in this assay, whereas progesterone acts neutrally. It is unclear if these findings may explain the different risks of breast cancer observed with progesterone, dydrogesterone, and other progestins such as medroxyprogesterone acetate and norethisterone in clinical studies.

Pharmacokinetics

Absorption

Surprisingly few studies have been conducted on the pharmacokinetics of MPA at postmenopausal replacement dosages. The bioavailability of MPA with oral administration is approximately 100%. A single oral dose of 10 mg MPA has been found to result in peak MPA levels of 1.2 to 5.2 ng/mL within 2 hours of administration using radioimmunoassay. Following this, levels of MPA decreased to 0.09 to 0.35 ng/mL 12 hours post-administration. In another study, peak levels of MPA were 3.4 to 4.4 ng/mL within 1 to 4 hours of administration of 10 mg oral MPA using radioimmunoassay. Subsequently, MPA levels fell to 0.3 to 0.6 ng/mL 24 hours after administration. In a third study, MPA levels were 4.2 to 4.4 ng/mL after an oral dose of 5 mg MPA and 6.0 ng/mL after an oral dose of 10 mg MPA, both using radioimmunoassay as well.

Treatment of postmenopausal women with 2.5 or 5 mg/day MPA in combination with estradiol valerate for two weeks has been found to rapidly increase circulating MPA levels, with steady-state concentrations achieved after 3 days and peak concentrations occurring 1.5 to 2 hours after ingestion. With 2.5 mg/day MPA, levels of the medication were 0.3 ng/mL (0.8 nmol/L) in women under 60 years of age and 0.45 ng/mL (1.2 nmol/L) in women 65 years of age or over, and with 5 mg/day MPA, levels were 0.6 ng/mL (1.6 nmol/L) in women under 60 years of age and in women 65 years of age or over. Hence, area-under-curve levels of the medication were 1.6 to 1.8 times higher in those who were 65 years of age or older relative to those who were 60 years of age or younger. As such, levels of MPA have been found to vary with age, and MPA may have an increased risk of side effects in elderly postmenopausal women. This study assessed MPA levels using liquid-chromatography–tandem mass spectrometry (LC–MS/MS), a more accurate method of blood determinations.

Oral MPA tablets can be administered sublingually instead of orally. Rectal administration of MPA has also been studied.

With intramuscular administration of 150 mg microcrystalline MPA in aqueous suspension, the medication is detectable in the circulation within 30 minutes, serum concentrations vary but generally plateau at 1.0 ng/mL (2.6 nmol/L) for 3 months. Following this, there is a gradual decline in MPA levels, and the medication can be detected in the circulation for as long as 6 to 9 months post-injection. The particle size of MPA crystals significantly influences its rate of absorption into the body from the local tissue depot when used as a microcrystalline aqueous suspension via intramuscular injection. Smaller crystals dissolve faster and are absorbed more rapidly, resulting in a shorter duration of action. Particle sizes can differ between different formulations of MPA, potentially influencing clinical efficacy and tolerability.

Distribution

The plasma protein binding of MPA is 88%. It is weakly bound to albumin and is not bound to sex hormone-binding globulin or corticosteroid-binding globulin.

Metabolism

The elimination half-life of MPA via oral administration has been reported as both 11.6 to 16.6 hours and 33 hours, whereas the elimination half-lives with intramuscular and subcutaneous injection of microcrystalline MPA in aqueous suspension are 50 and 40 days, respectively. The metabolism of MPA is mainly via hydroxylation, including at positions C6β, C21, C2β, and C1β, mediated primarily via CYP3A4, but 3- and 5-dihydro and 3,5-tetrahydro metabolites of MPA are also formed. Deacetylation of MPA and its metabolites (into, e.g., medroxyprogesterone) has been observed to occur in non-human primate research to a substantial extent as well (30 to 70%). MPA and/or its metabolites are also metabolized via conjugation. The C6α methyl and C17α acetoxy groups of MPA make it more resistant to metabolism and allow for greater bioavailability than oral progesterone.

Elimination

MPA is eliminated 20 to 50% in urine and 5 to 10% in feces following intravenous administration. Less than 3% of a dose is excreted in unconjugated form.

Level–effect relationships

With intramuscular administration, the high levels of MPA in the blood inhibit luteinizing hormone and ovulation for several months, with an accompanying decrease in serum progesterone to below 0.4 ng/mL. Ovulation resumes when once blood levels of MPA fall below 0.1 ng/mL. Serum estradiol remains at approximately 50 pg/mL for approximately four months post-injection (with a range of 10–92 pg/mL after several years of use), rising once MPA levels fall below 0.5 ng/mL.

Hot flashes are rare while MPA is found at significant blood levels in the body, and the vaginal lining remains moist and creased. The endometrium undergoes atrophy, with small, straight glands and a stroma that is decidualized. Cervical mucus remains viscous. Because of its steady blood levels over the long term and multiple effects that prevent fertilization, MPA is a very effective means of birth control.

Time–concentration curves

Chemistry

MPA is a synthetic pregnane steroid and a derivative of progesterone and 17α-hydroxyprogesterone. Specifically, it is the 17α-acetate ester of medroxyprogesterone or the 6α-methylated analogue of hydroxyprogesterone acetate. MPA is known chemically as 6α-methyl-17α-acetoxyprogesterone or as 6α-methyl-17α-acetoxypregn-4-ene-3,20-dione, and its generic name is a contraction of 6α-methyl-17α-hydroxyprogesterone acetate. MPA is closely related to other 17α-hydroxyprogesterone derivatives such as chlormadinone acetate, cyproterone acetate, and megestrol acetate, as well as to medrogestone and nomegestrol acetate. 9α-Fluoromedroxyprogesterone acetate (FMPA), the C9α fluoro analogue of MPA and an angiogenesis inhibitor with two orders of magnitude greater potency in comparison to MPA, was investigated for the potential treatment of cancers but was never marketed.

History

MPA was independently discovered in 1956 by Syntex and the Upjohn Company. It was first introduced on 18 June 1959 by Upjohn in the United States under the brand name Provera (2.5, 5, and 10 mg tablets) for the treatment of amenorrhea, metrorrhagia, and recurrent miscarriage. An intramuscular formulation of MPA, now known as DMPA (400 mg/mL MPA), was also introduced, under the brand name brand name Depo-Provera, in 1960 in the U.S. for the treatment of endometrial and renal cancer. MPA in combination with ethinylestradiol was introduced in 1964 by Upjohn in the U.S. under the brand name Provest (10 mg MPA and 50 μg ethinylestradiol tablets) as an oral contraceptive, but this formulation was discontinued in 1970. This formulation was marketed by Upjohn outside of the U.S. under the brand names Provestral and Provestrol, while Cyclo-Farlutal (or Ciclofarlutal) and Nogest-S were formulations available outside of the U.S. with a different dosage (5 mg MPA and 50 or 75 μg ethinylestradiol tablets).

Following its development in the late 1950s, DMPA was first assessed in clinical trials for use as an injectable contraceptive in 1963. Upjohn sought FDA approval of intramuscular DMPA as a long-acting contraceptive under the brand name Depo-Provera (150 mg/mL MPA) in 1967, but the application was rejected. However, this formulation was successfully introduced in countries outside of the United States for the first time in 1969, and was available in over 90 countries worldwide by 1992. Upjohn attempted to gain FDA approval of DMPA as a contraceptive again in 1978, and yet again in 1983, but both applications failed similarly to the 1967 application. However, in 1992, the medication was finally approved by the FDA, under the brand name Depo-Provera, for use in contraception. A subcutaneous formulation of DMPA was introduced in the United States as a contraceptive under the brand name Depo-SubQ Provera 104 (104 mg/0.65 mL MPA) in December 2004, and subsequently was also approved for the treatment of endometriosis-related pelvic pain.

MPA has also been marketed widely throughout the world under numerous other brand names such as Farlutal, Perlutex, and Gestapuran, among others.

Society and culture

Generic names

Medroxyprogesterone acetate is the generic name of the drug and its INN, USAN, BAN, and JAN, while medrossiprogesterone is the DCIT and médroxyprogestérone the DCF of its free alcohol form. It is also known as 6α-methyl-17α-acetoxyprogesterone (MAP) or 6α-methyl-17α-hydroxyprogesterone acetate.

Brand names

MPA is marketed under a large number of brand names throughout the world. Its most major brand names are Provera as oral tablets and Depo-Provera as an aqueous suspension for intramuscular injection. A formulation of MPA as an aqueous suspension for subcutaneous injection is also available in the United States under the brand name Depo-SubQ Provera 104. Other brand names of MPA formulated alone include Farlutal and Sayana for clinical use and Depo-Promone, Perlutex, Promone-E, and Veramix for veterinary use. In addition to single-drug formulations, MPA is marketed in combination with the estrogens CEEs, estradiol, and estradiol valerate. Brand names of MPA in combination with CEEs as oral tablets in different countries include Prempro, Premphase, Premique, Premia, and Premelle. Brand names of MPA in combination with estradiol as oral tablets include Indivina and Tridestra.

Availability

Oral MPA and DMPA are widely available throughout the world. Oral MPA is available both alone and in combination with the estrogens CEEs, estradiol, and estradiol valerate. DMPA is registered for use as a form of birth control in more than 100 countries worldwide. The combination of injected MPA and estradiol cypionate is approved for use as a form of birth control in 18 countries.

United States

As of November 2016, MPA is available in the United States in the following formulations:

  • Oral pills: Amen, Curretab, Cycrin, Provera – 2.5 mg, 5 mg, 10 mg
  • Aqueous suspension for intramuscular injection: Depo-Provera – 150 mg/mL (for contraception), 400 mg/mL (for cancer)
  • Aqueous suspension for subcutaneous injection: Depo-SubQ Provera 104 – 104 mg/0.65 mL (for contraception)

It is also available in combination with an estrogen in the following formulations:

  • Oral pills: CEEs and MPA (Prempro, Prempro (Premarin, Cycrin), Premphase (Premarin, Cycrin 14/14), Premphase 14/14, Prempro/Premphase) – 0.3 mg / 1.5 mg; 0.45 mg / 1.5 mg; 0.625 mg / 2.5 mg; 0.625 mg / 5 mg

While the following formulations have been discontinued:

  • Oral pills: ethinylestradiol and MPA (Provest) – 50 μg / 10 mg
  • Aqueous suspension for intramuscular injection: estradiol cypionate and MPA (Lunelle) – 5 mg / 25 mg (for contraception)

The state of Louisiana permits sex offenders to be given MPA.

Generation

Progestins in birth control pills are sometimes grouped by generation. While the 19-nortestosterone progestins are consistently grouped into generations, the pregnane progestins that are or have been used in birth control pills are typically omitted from such classifications or are grouped simply as "miscellaneous" or "pregnanes". In any case, based on its date of introduction in such formulations of 1964, MPA could be considered a "first-generation" progestin.

Controversy

Outside the United States

  • In 1994, when DMPA was approved in India, India's Economic and Political Weekly reported that "The FDA finally licensed the drug in 1990 in response to concerns about the population explosion in the third world and the reluctance of third world governments to license a drug not licensed in its originating country." Some scientists and women's groups in India continue to oppose DMPA. In 2016, India introduced DMPA depo-medroxyprogesterone IM preparation in the public health system.
  • The Canadian Coalition on Depo-Provera, a coalition of women's health professional and advocacy groups, opposed the approval of DMPA in Canada. Since the approval of DMPA in Canada in 1997, a $700 million class-action lawsuit has been filed against Pfizer by users of DMPA who developed osteoporosis. In response, Pfizer argued that it had met its obligation to disclose and discuss the risks of DMPA with the Canadian medical community.
  • Clinical trials for this medication regarding women in Zimbabwe were controversial with regard to human rights abuses and Medical Experimentation in Africa.
  • A controversy erupted in Israel when the government was accused of giving DMPA to Ethiopian immigrants without their consent. Some women claimed they were told it was a vaccination. The Israeli government denied the accusations but instructed the four health maintenance organizations to stop administering DMPA injections to women "if there is the slightest doubt that they have not understood the implications of the treatment".

United States

There was a long, controversial history regarding the approval of DMPA by the U.S. Food and Drug Administration. The original manufacturer, Upjohn, applied repeatedly for approval. FDA advisory committees unanimously recommended approval in 1973, 1975 and 1992, as did the FDA's professional medical staff, but the FDA repeatedly denied approval. Ultimately, on 29 October 1992, the FDA approved DMPA for birth control, which had by then been used by over 30 million women since 1969 and was approved and being used by nearly 9 million women in more than 90 countries, including the United Kingdom, France, Germany, Sweden, Thailand, New Zealand and Indonesia. Points in the controversy included:

  • Animal testing for carcinogenicity – DMPA caused breast cancer tumors in dogs. Critics of the study claimed that dogs are more sensitive to artificial progesterone, and that the doses were too high to extrapolate to humans. The FDA pointed out that all substances carcinogenic to humans are carcinogenic to animals as well, and that if a substance is not carcinogenic it does not register as a carcinogen at high doses. Levels of DMPA which caused malignant mammary tumors in dogs were equivalent to 25 times the amount of the normal luteal phase progesterone level for dogs. This is lower than the pregnancy level of progesterone for dogs, and is species-specific.
    DMPA caused endometrial cancer in monkeys – 2 of 12 monkeys tested, the first ever recorded cases of endometrial cancer in rhesus monkeys. However, subsequent studies have shown that in humans, DMPA reduces the risk of endometrial cancer by approximately 80%.
    Speaking in comparative terms regarding animal studies of carcinogenicity for medications, a member of the FDA's Bureau of Drugs testified at an agency DMPA hearing, "...Animal data for this drug is more worrisome than any other drug we know of that is to be given to well people."
  • Cervical cancer in Upjohn/NCI studies. Cervical cancer was found to be increased as high as 9-fold in the first human studies recorded by the manufacturer and the National Cancer Institute. However, numerous larger subsequent studies have shown that DMPA use does not increase the risk of cervical cancer.
  • Coercion and lack of informed consent. Testing or use of DMPA was focused almost exclusively on women in developing countries and poor women in the United States, raising serious questions about coercion and lack of informed consent, particularly for the illiterate and for the mentally challenged, who in some reported cases were given DMPA long-term for reasons of "menstrual hygiene", although they were not sexually active.
  • Atlanta/Grady Study – Upjohn studied the effect of DMPA for 11 years in Atlanta, mostly on black women who were receiving public assistance, but did not file any of the required follow-up reports with the FDA. Investigators who eventually visited noted that the studies were disorganized. "They found that data collection was questionable, consent forms and protocol were absent; that those women whose consent had been obtained at all were not told of possible side effects. Women whose known medical conditions indicated that use of DMPA would endanger their health were given the shot. Several of the women in the study died; some of cancer, but some for other reasons, such as suicide due to depression. Over half the 13,000 women in the study were lost to followup due to sloppy record keeping." Consequently, no data from this study was usable.
  • WHO Review – In 1992, the WHO presented a review of DMPA in four developing countries to the FDA. The National Women's Health Network and other women's organizations testified at the hearing that the WHO was not objective, as the WHO had already distributed DMPA in developing countries. DMPA was approved for use in United States on the basis of the WHO review of previously submitted evidence from countries such as Thailand, evidence which the FDA had deemed insufficient and too poorly designed for assessment of cancer risk at a prior hearing.
  • The Alan Guttmacher Institute has speculated that United States approval of DMPA may increase its availability and acceptability in developing countries.
  • In 1995, several women's health groups asked the FDA to put a moratorium on DMPA, and to institute standardized informed consent forms.

Research

DMPA was studied by Upjohn for use as a progestogen-only injectable contraceptive in women at a dose of 50 mg once a month but produced poor cycle control and was not marketed for this use at this dosage. A combination of DMPA and polyestradiol phosphate, an estrogen and long-lasting prodrug of estradiol, was studied in women as a combined injectable contraceptive for use by intramuscular injection once every three months.

High-dose oral and intramuscular MPA monotherapy has been studied in the treatment of prostate cancer but was found to be inferior to monotherapy with cyproterone acetate or diethylstilbestrol. High-dose oral MPA has been studied in combination with diethylstilbestrol and CEEs as an addition to high-dose estrogen therapy for the treatment of prostate cancer in men, but was not found to provide better effectiveness than diethylstilbestrol alone.

DMPA has been studied for use as a potential male hormonal contraceptive in combination with the androgens/anabolic steroids testosterone and nandrolone (19-nortestosterone) in men. However, it was never approved for this indication.

MPA was investigated by InKine Pharmaceutical, Salix Pharmaceuticals, and the University of Pennsylvania as a potential anti-inflammatory medication for the treatment of autoimmune hemolytic anemia, Crohn's disease, idiopathic thrombocytopenic purpura, and ulcerative colitis, but did not complete clinical development and was never approved for these indications. It was formulated as an oral medication at very high dosages, and was thought to inhibit the signaling of proinflammatory cytokines such as interleukin 6 and tumor necrosis factor alpha, with a mechanism of action that was said to be similar to that of corticosteroids. The formulation of MPA had the tentative brand names Colirest and Hematrol for these indications.

MPA has been found to be effective in the treatment of manic symptoms in women with bipolar disorder.

Veterinary use

MPA has been used to reduce aggression and spraying in male cats. It may be particularly useful for controlling such behaviors in neutered male cats. The medication can be administered in cats as an injection once per month.

See also


Neuropharmacology

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