By Melinda Young
People are interested in a reversible and effective male contraceptive at a time when researchers are closer than ever to making this a reality, studies show.1,2 “The idea that reproductive health is only a women’s burden is certainly false,” says Brian T. Nguyen, MD, MSc, program director of fellowship and complex family planning and associate professor in the department of obstetrics and gynecology at the Los Angeles General Medical Center, Keck School of Medicine of the University of Southern California in Los Angeles. Contraception and abortion access are relevant to everyone, he adds.
“There has always been an evolving interest in male contraception over time, as we change as a culture,” Nguyen notes. “Look back 10 years ago, a lot of our gender norms were not the same as they are today; there are more men taking on domestic roles and more women in the workforce.” These cultural changes make it natural for men to pay more attention to reproductive responsibility than they did in the past.
Men are more aware now — a few years after the U.S. Supreme Court overturned Roe v. Wade — than they ever were before that they need to protect themselves from getting a partner pregnant, particularly if abortion is taken off the table, he adds. A new study showed a spike in Google searches for “male birth control” after the Dobbs v. Jackson Women’s Health Organization decision in June 2022.1
“In our work, we looked at what was in the minds of men at the time directly after the release of the Dobbs decision, and there was a spike in male contraception being something people think of as an alternative or solution,” Nguyen explains. “You could make the argument that it might be women who are searching for male contraception, but that can’t be the only demographic. There have to be men who are interested, as well.”
The COVID-19 pandemic slowed down enrollment in Phase II trials of a promising hormonal male contraceptive called the Nestorone/testosterone (NES/T) transdermal gel. Researchers were able to enroll 462 couples over a two-year period that included a slower enrollment time during the COVID-19 pandemic, says Régine Sitruk-Ware, MD, a distinguished scientist with Population Council. She works in the laboratories at the Center of Biomedical Research at Rockefeller University in New York, NY.
After the Phase II trials were successful, researchers began to prepare to conduct a Phase III trial with the goal to bring the male contraceptive to market. It would be the first novel male contraceptive, and this achievement has been anticipated for more than 50 years.
“We worked all last year with a very promising partner — a small company involved in male contraception, and they are looking for investors to support the Phase III program of the gel,” Sitruk-Ware says. There are committed investors that would enable the research to continue and to fund bringing it to market, she adds. “There is hope we would be able to continue,” she says.
Much as the pandemic interrupted research in an unprecedented way, the current presidential administration also might interrupt research with its funding cuts to the National Institutes of Health (NIH) and to university research labs.3
“What we don’t know is how the work we are conducting with the National Institutes of Health will evolve,” Sitruk-Ware says. “We are working very closely with NIH and clinical investigators to prepare clinical study reports of the completed phase IIB study and manuscript.”
Investigators are working on data analyses plans and hope to publish the IIB study results later this year. “We are doing additional preclinical studies in animals to meet requirements of the Food and Drug Administration (FDA),” she says. Once these tasks are complete, they will send a study report to the FDA for approval to start Phase III. In the meantime, there are couples waiting to participate. “We have couples who want to enter into the study,” Sitruk-Ware says. The only variable is if NIH and the clinical trials network experience changes that stall studies, such as the male contraceptive gel trials.
Even without political and funding changes affecting the research, there are many obstacles that have prevented other male contraceptive prospects from making it to Phase III trials. These include regulatory hurdles and the lack of guidance on how to administer contraception to men. Industry did not want to embark on costly trials if the product would not be approved, for instance.
The Population Council and other experts have written a white paper on male contraception to embolden the FDA and other health authority representatives to write guidance, she notes.
One reason the gel might cross the finish line first is because it is not an entirely new product. The gel was designed for female contraception but was adapted for use in men. The NIH had collaborated with the Population Council about 20 years ago, when the gel was being developed for female contraception, and the NIH remained interested when investigators pivoted to a male contraception option. (See article on developing first male contraceptive gel in the August 2024 issue of Contraceptive Technology Update.)
There are two other male contraceptives that show promise, including one that could be a reversible vasectomy, but they are not as far along in clinical studies, Sitruk-Ware says.
The research suggests the contraceptive is not for every man because it may worsen depression in people who have a history of depression. But overall it showed promise and should be a good Phase III candidate, she adds. “We have learned how to apply these treatments to the right population, and we didn’t have any bad surprises,” she says.
Side effects have been a barrier for male contraception over the years. While side effects of headaches, night sweats, acne, mood changes, and others have been an acceptable tradeoff for women who do not want to become pregnant, men might have less motivation, Sitruk-Ware explains.
But this is changing as more men say they want to share responsibility for pregnancy prevention. “A much higher percentage of men are willing to use the contraceptive if it comes to market when compared with surveys in 2005,” Sitruk-Ware says. These surveys give a positive answer to questions about enrollment in clinical trials and marketing the product should it be approved and made available to the public.
This change in men’s outlook about male contraception tracks with what Nguyen has seen in research, as well. “There are a lot more powerful arguments now for men recognizing they have to do something,” he says. After the Dobbs decision, the biggest spikes in Google searches for male contraception occurred in states with more restrictive abortion policies, Nguyen adds.
“The peak searchers went up to 1,400 per month right after Dobbs, whereas baseline levels were 100 to 200 per month,” he says. “And there is not a product on the market. So, people would do the search, look for it, and then not find it.”
This suggests that, when there is an actual male contraceptive on the market, many people would be interested, and that is what investors want to see. “The gel could work,” Nguyen says.
“The fight for male contraception is a fight for gender equity and for not putting the entire focus of reproductive responsibility on women and for stopping the blame of women when pregnancy happens,” he explains. “A lot of the shame women feel that is attached to abortion is because we’re not expecting men to take responsibility.”
While women are threatened with arrest and jail if they pursue an abortion, the male partners are not threatened in the same way — even if they are accomplices, he adds. Bringing a reversible and effective male contraceptive to market is acknowledging men’s role in reproductive responsibility, and it is frustrating that it still has not happened, Nguyen says.
Melinda Young has been a healthcare and medical writer for 30 years. She currently writes about contraceptive technology.
References
1. Brewer C, Nguyen BT. Web traffic and Google Trends data show increased interest in novel male contraception following the Supreme Court’s Dobbs v. Jackson ruling. Contraception. 2025;Jan 30:110835. [Online ahead of print].
2. Sitruk-Ware R, Blithe DL, Page ST, Wang C. Development of a transdermal gel for reversible male contraception. Contraception. 2025; Jan 23:110830. [Online ahead of print].
3. Choi J. Trump’s move to slash research funding shakes medical community. The Hill. Feb. 13, 2025. https://thehill.com/policy/healthcare/5141905-trump-medical-research-cuts-threat/
People are interested in a reversible and effective male contraceptive at a time when researchers are closer than ever to making this a reality, studies show.
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