When Julia Medrano was using the injectable hormonal contraceptive Depo Provera as birth control, she would often argue with her now-husband Michael was about how the drug affected her. “I used to say she’d get moody whenever she was on the birth control,” said Michael. Julia suggested he start taking the birth control, and he said fine — except there was no medical birth control for men. But when an ad popped up last year on Reddit about participating in a male birth control trial collaboration between the National Health Institute and The Population Council, Michael decided he had to see what it was about.
Michael and Julia, who live in Lake Elsinore, California, are one of more than 400 couples around the world who will participate in a clinical trial for a male contraceptive gel called NES/T. The gel, which is applied on the shoulders, combines a progestin compound that blocks natural testosterone production, making a man’s sperm count low enough to significantly reduce the risk of pregnancy, and a replacement testosterone that allows patients to maintain a normal sex drive and other testosterone-dependent functions.
While the researchers are still recruiting participants, Michael started using the contraceptive gel back in January, and it’s already become a part of his routine. “It kind of feels like hand sanitizer,” he said. “Between putting it on and waiting for it to dry, it takes about maybe two minutes.” But while Medrano now finds applying the gel pretty normal, he’s actually in uncharted territory — this trial is unlike any conducted in the past.
The fight for male contraception has been, and will likely continue to be, an uphill battle. Major pharmaceutical companies have shown little interest in developing male contraceptives, and while a recent survey from the Male Contraceptive Initiative does show that around eight million men are “very likely” to use a male method of birth control, MCI’s specific agenda is to promote male contraception (MCI is a 501(c)(3) nonprofit that has not disclosed its donors, but it’s worth noting that new pharmaceuticals are worth billions of dollars to their patent holders). Little independent research exists on the male demand for contraception, so it’s hard to place the MCI’s figures in context. For comparison’s sake, around 11 million women are on the contraceptive pill in the U.S.
While male contraceptives have been in development for men as long as they have for women, NES/T is the first time a hormonal male contraceptive has been tested to actually prevent pregnancy. And that means a different methodology, observing not only the men who are applying the gel, but also their female partners.
Obviously, many women would probably love to not exclusively bear the burden of contraception, if there were a way to do it without exposing themselves to more risk. Men have written and talked about their desire for more contraceptive options, and some have even gone so far as to try to hack their fertility by doing things like soaking their testicles in hot water.
Dr. Christina Wang, lead researcher at the nonprofit Los Angeles Biomedical Research Institute (known colloquially as LA BioMed) and a principal investigator for the trial, has been working steadily to find an effective male method for contraception for over a decade. She said she realized a gel might work well as a male contraceptive because gel was also the most popular method for testosterone replacement in men. Since 2007, Wang has been working to find a formulation of gel that would suppress sperm production sufficiently to prevent pregnancy in over 95 percent of men, and to find the exact protocol patients would need to follow to make sure the gel was effective.
In the trial, Wang instructs participants to apply the gel anytime “that’s convenient to them,” but ideally they will apply it at the same each day. After application, Wang advises not to shower for at least four hours, so that all of the compounds in the gel can be completely absorbed into the skin and release over the next 24 hours. Once the gel is dry, subjects also must avoid skin to skin contact until they shower again, otherwise the hormones could cause as-yet-unknown side effects for anyone they touch.
According to Logan Nickels, the director of operations and programs at MCI, hormonal contraceptives for men are particularly challenging to develop because “the same hormones that shut down sperm production are pretty easily cleared from the body.” Because of that, for a male hormonal pill to work, he said, men would have to take it multiple times a day; the gel offers a different solution.
Michael said he just applies the gel between showering and going his job at a local body shop, where he wears long sleeves anyway, so skin-to-skin contact isn’t an issue. But it has changed how he interacts with his son in the mornings. “I don't like to touch him, with my hands, or, you know, sometimes I would make him a sandwich for lunch or fix his breakfast. But now it's more of a Julia thing,” he said.
Wang is hoping that the gel will still be comparatively “user friendly,” since patients can apply the gel at home rather than, say, going to a clinic for an injection. But throughout the trial, participants will be filling out questionnaires about how they feel about the method, so Wang and her team can monitor whether patients find it too inconvenient. Nickels said these kinds of logistical issues might be too difficult for some patients, but that it and any similar future products “can really begin to build out what will hopefully be an eventual menu of options for men and women,” so that “anyone can find something that fits their lifestyle and their needs.”
According to Wang, “For the first couple months of the trial, [couples] have to use another method of contraception until their sperm count is suppressed to a very low level of one million per milliliter.” The study protocol states the gel takes about 20 weeks to ramp up to full efficacy. Once a man’s sperm count is down, all trial participants are instructed to stop using any other method of contraception; men will continue to apply the gel in the same way every day for a year to test its efficacy.
Women are also tested for pregnancy and other side effects throughout the course of the trial. Female partners are asked to regularly report whether they’re experiencing side effects like acne, for example, and will also have to have their blood drawn and tested. And, according to Wang, because both members of a couple participate, recruiting for the trial is also a challenge: Both people must be in a stable relationship, both must be healthy, and both must be under a certain age.
The Food and Drug Administration does not yet have standards in place for reversible male contraception, so Dr. Wang doesn’t know exactly how effective the gel would need to be to get approval, although she is using the standards for reversible female contraception as a jumping off point. While couples like the Medranos have already started the trial, recruitment efforts are underway worldwide in England, Scotland, Italy, Sweden, Kenya and Chile, where the Phase 2B trial should start by the end of the year. And if NES/T does get approved, finding a way to get it to market will be its own challenge.