Heather Vahdat has been advocating for male contraceptive options for nearly a decade, but she is the first to say it is a lonely space to occupy in the health science field.

Vahdat is the executive director of the Male Contraceptive Initiative, based in Durham, North Carolina, which has been working with a single donor to provide up to $1.5 million in grants per year for emerging male birth control technologies since 2017 — and that makes it the second largest funder of that type of research in the U.S., second only to the National Institutes of Health.

At the moment, the options for men are limited to condoms and vasectomies, Vahdat said, and while vasectomies can potentially be reversed, it doesn’t always work.

Vahdat says demand for male contraceptives was already stronger than most would guess, but the U.S. Supreme Court’s Dobbs decision in 2022 was a tipping point.

“After Roe fell, women looked around and said, ‘What can you do?’ and men looked around and said, ‘Crap, what can I do?’” Vahdat said. “Men are waiting for this; I think it’s really underestimated how much attention men are paying to this.”

Cody Romero, a 32-year-old single Idaho resident, said he will be happy to take any method of male contraception once it is available, especially in the current environment of abortion restrictions.

After all, even with the birth control methods that are available for women, a recent estimate showed half of the world’s yearly pregnancies are unplanned. In the United States, as of 2019 data from the Guttmacher Institute, there were about 45 unintended pregnancies per 1,000 women between the ages of 15 and 44.

“I don’t like the idea of getting someone pregnant. That’s scary,” Romero said. “I always feel bad for the ladies that do get on birth control and struggle with some of them. It’s like, ‘Well, this is my fault as well.’”

Romero had only heard of a study on hormonal pills for male birth control that was cut short after some of the participants experienced adverse psychological effects — that was in 2016. But he said he is open to any method, particularly since he does want children at some point and doesn’t want a vasectomy at his age.

Romero said among the men he knows, subjects like contraception are rarely talked about. But if more options became available, he thinks many of them would be interested in taking the contraception burden on themselves.

“Right now, it just feels like that’s not something they need to take care of, ‘It’s someone else’s problem’ sort of thing, that’s the impression I get,” Romero said.

?Potential 10 years of birth control with injectable gel

Although male contraceptives have been discussed and researched since as early as the 1950s, Vahdat said there has been little interest from pharmaceutical companies to invest in options for men. The Male Contraceptive Initiative has provided grant funding for research at institutes such as Emory University, Baylor College of Medicine, the University of North Carolina at Chapel Hill and Yale University.

The initiative also partnered with the Bill and Melinda Gates Foundation to produce research released in February that assessed the demand for potential contraceptives for men across various regions of the world, including the United States, India, Africa and Vietnam. Two thousand men were surveyed in each country, and in the U.S., 78% of those surveyed said they would use male contraceptive methods if available. That included options such as hormonal pills, a gel that is rubbed into the shoulder, a nasal spray and implants or injections.

The organization is planning to replicate the survey in the U.S. to assess interest after the fall of Roe and the return of abortion regulation to the states.

One of the grants the Male Contraceptive Initiative provided in the last few years was for a hydrogel developed by Virginia-based business Contraline called ADAM, which is a similar technology in development by a company called NEXT Life Sciences.

Contraline representatives could not be reached for comment, but the ADAM technology is in use in a clinical trial in Australia that is expected to be completed by 2025.

L.R. Fox, CEO of NEXT Life, said his California-based company acquired rights to vasalgel from the Parsemus Foundation. Vasalgel is a technology derived from a hydrogel that has been used in clinical trials in India for about 30 years called Reversible Inhibition of Sperm Under Guidance, or RISUG, according to Fox. NEXT Life is calling their product Plan A.

The non-hormonal contraceptive method involves the injection of a substance called vasalgel that forms a small, flexible filter inside the vas deferens — the duct that produces sperm — and filters sperm out while allowing other fluids to pass through.

The injection would take place during a quick doctor’s visit with local anesthetic, Fox said, and he said it could potentially provide up to 10 years of birth control that could be reversed at any time. He likened it to non-hormonal IUD implants.

The company will begin clinical trials with Plan A at the end of this year, so those numbers are preliminary, according to Fox, but they are based on data from trials in India and animal studies, which he said have been promising so far. That length of time, if it holds true in clinical trials, will be much longer than similar hydrogel formulations, Fox said.

“Since the overturn of Roe, the only effective contraceptive option for men is currently a vasectomy, which solves the long-lasting problem, but is designed to be permanent,” Fox said. “Therefore, it’s primarily only used by men who are child complete at 45 or often 65 and older, so what we see is this massive demand from men who are in their 20s and 30s who are in committed relationships and who are saying they want to be able to participate in the family planning process.”

Contraception takes two, initiative leader says

The lack of investment into the development of male contraception hasn’t gone unnoticed by Fox, who said he grew up in the foster care system and saw firsthand the “devastating consequences” that can occur when someone can’t choose when to have a child.?

“People aren’t recognizing the problem because they sit back and say, ‘Well, is it really needed?’ because women have a solution,” Fox said. “The assumption is we can just burden women with contraception that clearly is not sufficient.”

Fox said 50,000 people have expressed interest in the product, and if all goes as planned, he hopes Plan A will have approval from the U.S. Food and Drug Administration and roll out on the market by 2026, which is “just right around the corner,” he said.?

Fox believes Plan A represents the best option because of its simplicity and potential effectiveness.

“Of course, those (pills and creams) are incredibly valuable contributions to science, but at the same time, one of the big concerns is how can you ensure effectiveness and also how do we remove user error?” Fox said. “That’s why something long lasting and reversible is so key.”

From Vahdat’s perspective, it is unrealistic to expect an option to hit the market by 2026 given all of the bureaucratic hurdles involved in clinical trials and approval that can take years to complete. A 2018 study from the Tufts Center for the Study of Drug Development showed FDA-approved drugs and biologics spent an average of nearly 90 months — more than seven years — in the clinical trial phase, although Fox points out that Plan A is a medical device, which average a faster timeline of three to seven years.

But Vahdat does think the market in general is on a steady upward trajectory.

“What we can’t do is slow that momentum,” she said.

Vahdat said she’d love to see more investment from donors and organizations, but what will also aid the speed of bringing products to market is individuals demanding more options. Because in the meantime, the options remain limited.

“We have to stop looking at contraception as either for men or for women. Like conception, you need two people,” she said. “So with the onus being on women, we’ve kind of gendered that term, but really contraception is about two people preventing an unintended pregnancy.”