Center for Male Contraceptive
Research & Development

Based on data from the Guttmacher Institute, even in high income countries, about 1/3 of pregnancies are UNINTENDED, about HALF of which will end in an ABORTION. More contraceptive methods and greater accessibility to contraceptive methods can help to decrease the rate of unintended pregnancy. https://www.guttmacher.org/fact-sheet/induced-abortion-worldwide

Abortion is NOT just a women's issue because men experience abortion and have feelings about it too. In this publication, we found that when you survey a nationally representative sample of reproductive age men, approximately 20% will report having had an abortion. https://doi.org/10.1016/j.contraception.2022.01.012

Absolutely, but you don't have to take my word for it. Hear from one of our male contraceptive clinical trial couples:

Limitations of current female contraceptive methods: Desire to avoid a procedure or have a foreign body in place (IUD’s/Implants) Dissatisfaction with off-target hormonal effects Lack of adherence to daily/weekly/monthly methods Difficult to obtain refills of daily/weekly/monthly methods Co-morbidities make some women ineligible for estrogen-based methods Inability to personally confirm that their method is working DON'T WOMEN ALREADY TAKE UP ENOUGH REPRODUCTIVE BURDENS ALREADY!?!

We've tried! In the CONTRACEPTIVE CHOICE Project, researchers in St. Louis, Missouri (https://contraceptivechoice.wustl.edu/) offered FREE contraceptive counseling and contraceptive methods to anyone who wanted these services. When all these barriers were removed, 1/3 of women STILL chose short-acting methods. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2910826/

Vasectomy is a GREAT option, it's safer and more effective than tubal ligation for women, BUT it's not for everyone. Some people have suggested that men could get vasectomies at an early age for contraception and then just get the procedure reversed later. But there's a catch! Vasectomy reversal is EXPENSIVE, estimated to cost approximately $20,000, and is RARELY covered by health insurance plans! Even when couples get vasectomy reversed, and even when the vas deferens (male tubes) are successfully reconnected (vasovasostomy), about 57% will STILL BE UNABLE TO GET PREGNANT. https://www.fertstert.org/article/S0015-0282(01)03219-8/fulltext When couples get vasectomy reversal, it tends to happen when they're older and LESS LIKELY to get pregnant on their own. For about 25% of couples, it can take 2 years to get pregnant after reversal.

Condoms affect sexual pleasure and it's NOT just men who think so! The Kinsey Institute found in an online survey of 189 women that women using condoms reported more than 6x the odds of reporting that they enjoyed sex LESS because of their method of contraception than women who were using a hormonal method. Condoms are also not 100% effective. Not even close, actually--18 out of 100 couples using condoms will experience a pregnancy each year.

Based on data from the National Survey of Family Growth (2015-2017), about 15% of women are using a male method of contraception. That means that about 22.5% of women who are USING contraception are relying on a male method of contraception. That's not small and that's a proportion that COULD be using a novel male contraceptive method!

Acceptability studies have been incorporated into the majority of clinical trial protocols "Surveys undertaken among the male general public demonstrate that, whatever the setting, at least 25% of men — and in most countries substantially more — would consider using hormonal contraception"

Pharmaceutical Support: - Profitability: Zero-Sum Game? - Loss of funding from Schering & the Bill and Melinda Gates Foundation - Lack of Contraceptive Researchers/Scientists Risks > Benefits in men? Benefits > Risks in women? Would men actually USE it? Would women TRUST men to use it?

MHCs work by stopping the signals and processes that control sperm production. The brain (via the hypothalamus) detects the body's testosterone (T) levels and determines whether to send signals (GnRH, LH, and FSH) to the testes to make more. The amount of T floating around the testis controls sperm production. Giving additional T or similar hormone signals, like androgens and progestins, can trick the brain and prevent it from signaling more T production in the testes. Without high enough levels of T in the testes, sperm production is shut down. The T in the bloodstream remains normal, maintaining male features, like muscle tone and libido. Given androgens AND progestins in combination can help to produce both quicker and more complete suppression of spermatogenesis.

The first proof of concept was published in 1977 n=16 healthy adult males Induction: Testosterone enanthate 200mg/mL IM 2x/wk Maintenance: 1x/wk for 2wks, 1x every other wk for 1 month Testosterone levels remained within the normal range COMPLETE suppression of gonadotropins (LH): <0.4mIU/mL needed to achieve azoospermia [rebound otherwise]

The first hormonal male contraceptive formulations used various forms of testosterone alone. However, testosterone alone requires high doses and prolonged use in order to adequately suppress sperm counts to contraceptive ranges. Consequently, modern forms of hormonal male contraception combine a progestin with testosterone in order to more quickly and more completely stop sperm development. A range of hormonal combinations have been examined, but the current candidates include: A hormonal gel containing a combination of Nestorone and Testosterone that men apply daily to their shoulders. An oral pill containing a single hormone that has both progestogenic and androgenic properties called, 11B-MNT or 11 Beta-Methyl-nortestosterone. An injectable containing a single hormone that has both progestogenic and androgenic properties called, DMAU or dimethandrolone undecanoate.

One of the most unique features of hormonal male contraception is that all users need to go through a semen analysis in order to prove that their sperm count has been sufficiently decreased before they can rely on it for pregnancy prevention. This is DIFFERENT from female contraception where there is no non-invasive way to test whether or not a woman's method is actually working. If men are able to verify that they have 0 sperm in their semen, the risk of pregnancy is effectively 0%! In the last male contraceptive efficacy trial where men received injections of Norethisterone enanthate and Testosterone Undecanoate every 8 weeks, researchers followed 266 couples for an entire year and only 4 (1.57%) became pregnant. In these couples, the male partner's sperm counts rebounded and ranged anywhere from 0.2 -1 million/mL. We use the Pearl Index to rate how effective different methods of contraception are and the Pearl Index for this male contraceptive injectable was 2.18 pregnancies per 100 person-years (95% CI, 0.82–5.80). For more details, check out the actual publication at the following link: Also check out this summary of older male contraceptive efficacy clinical trials where pregnancy rates were still comparable to female hormonal contraceptive methods!

The goal of any non-permanent contraceptive method is to ensure not only effectiveness but REVERSIBILITY. Hormonal male contraceptives are one of safest and most promising methods thanks to our long-term experience with female contraception. We expect that when users stop using hormonal male contraception, that sperm production will restart again just like egg production starts again in women. On the left is data from our HORMONAL MALE CONTRACEPTIVE GEL study where men received daily T+NES for 6 months. While not all of them dropped their sperm count to effective levels, ALL recovered within 10 months. DID YOU KNOW? It can take more than 2 months to form new sperm, so we expect that men won't get normal levels back immediately. Chill, bro! Check out the published data for more details:

•WHO, 1990: AZOOSPERMIA for contraception •n=271 couples, 10 centers, 7 countries •Testosterone enanthate 200mg IM q week •“…the regimen was selected because its safety, reversibility, and efficacy in making men azoospermic is well known. The practicality of TE as a contraceptive method was not investigated.” •(1) Suppression phase: azoospermia is possible? •3 consecutive azoospermic specimens at 2 wk intervals •(2) Efficacy phase: 12 months reliant only on the male •(3) Recovery phase: monthly f/u until 20 million sperm/mL •WHO, 1990: SUPPRESSION PHASE •Chinese centers w/ higher rate of azoospermia (91% vs 60% other). •Mean time to azoospermia = 120 days (4 months) •Can miss 1 wk injection by up to 2 days w/out rebound

The development of male contraception is going to be DEPENDENT on people like you to raise awareness about male contraception. Talk about it. Spread the word. It's happening, but it won't happen quickly unless pharmaceutical industries start listening. So get on your social media soapbox and let everyone know.

For contraceptive efficacy trials, we can only determine if the drug is able to prevent pregnancy if couples are actually having sex WITHOUT using any other method of contraception. Because our efficacy trials require couples to rely on the drug for more than a year, we typically recruit couples who are stable in their relationship.

Our clinical trials recognize that we have healthy human volunteers whose only risk is being part of the trial. We're not curing an individual's disease and so there's little to gain other than the satisfaction of supporting research in male contraception. Consequently, we have to maintain safety above all, being unwilling to risk worsening a condition or incurring an adverse event that may be related to the person's pre-existing health risk, rather than the study drug itself. Exceptions are rare and studies on other populations with specific conditions are reserved for later trials.

Withdrawal is not a recognized form of contraception by the CDC and WHO and thus cannot be used by itself during the trial. Even if it may confer less risk than not using anything at all, please make sure you're using another methods or abstaining unless otherwise instructed.

In order to accurately calculate the effectiveness of a contraceptive method, you have to make sure the denominator makes sense. For example, if a woman isn't ovulating during the 12 months that she and her partner are in the trial, including those months in the denominator would make the drug seem more effective than it really is. So, collecting menstrual data helps us know if a woman is regularly ovulating. For the gel trial specifically, we're also looking for cases of the gel being transferred from partner to partner and if a woman would subsequently have cycle-related changes.

For the HMC gel trial, we are trying to determine contraceptive efficacy over the course of 1 year.

Unfortunately, it can take a little while for a man's sperm count to go down to levels low enough to effectively prevent preganancy. No hormonal methods work immediately and it can take up to 3 months among some men. Newer methods that combine androgens with progestins can drop the latency time by about 1 month, during which couples should be using another method of birth control.

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We know that giving topical testosterone (T) can increase a man's average blood pressure by about 2-3mmHg over time. However, how blood pressure will be impacted by MHCs that combine T and another progestin, is unknown. While elevations in blood pressure beyond 5mmHg have been associated with cardiovascular disease, we do not expect changes of this magnitude in our trials. However, we will be regularly monitoring the blood pressures of our participants. At this time we will not be accepting men with a blood pressure of 135/85. To make sure your blood pressure is measured at its best, watch this video from the American Medical Association for tips: https://youtu.be/vXNE-ilnyw4

Yes, for some men, the use of a hormonal male contraceptive was reported to increase their libido. It's difficult at this time to explain why. It may have been related to the hormones in the drug, however it may also have been the idea of being on the drug. For example, men who receive vasectomies have also been known to report increased sexual satisfaction due to the additional confidence that they won't get someone pregnant and possibly what connection can be gained in their relationship from shared reproductive responsibility. While all this sounds good, we are still collecting data on increased libido as a possible adverse side effect because if it becomes a behavioral change that affects women in a negative way, we'd like to pay attention to that risk early.

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Hormonal male contraceptives are the most well-studied and closest to market and so we've focused our efforts on researching and raising awareness about those methods. However, if you'd like to learn more about non-hormonal methods, check out our colleagues' informational site https://www.malecontraceptive.org/. The Male Contraceptive Initiative has funded such projects as the occlusive method, Contraline: https://www.malecontraceptive.org/contraline.html They even created this nifty video comparing Hormonal vs. Non-Hormonal Male Contraception.