After Roe, men could finally get better birth control

Phase 2 trials test a drug for both efficacy and safety, typically involving hundreds of volunteers, and look for harmful or unpleasant drug reactions. An earlier phase 2 study of an injectable hormone-based male contraceptive was stopped in 2011 because the drug had too many side effects, including muscle pain, increased libido, acne and depression. Its development was supported by the World Health Organization and CONRAD, a non-profit reproductive health organization.

In the gel study, side effects can include weight gain and mood problems. “There will be a small percentage of men who will experience some type of side effect, but we know that this is also true for many different female birth control pills,” says Creinin. “We’re not looking for the product that works perfectly for every single man; We are looking for the product that works very well for the majority of people.”

Next, the gel needs to be tested in a larger Phase 3 clinical trial that will likely involve thousands of couples. It will also need a pharmaceutical company to make it and bring it to market since the NIH and the Population Council are unable to commercialize drugs. (The NIH is also sponsoring early trials of hormone pills aimed at lowering sperm count by suppressing testosterone.)

Funding has been a major hurdle for male contraceptives: In recent years, pharmaceutical companies have not been involved in its research and development. Instead, philanthropic organizations and the public sector have been the primary funders of such efforts.

But investment firms like Rhia Ventures, a San Francisco-based company focused on reproductive health, are trying to reverse this problem. CEO Erika Seth Davies says it’s important that non-hormonal forms of male contraception are available. “In this post-roe world, ensuring there is a robust contraceptive supply and access to contraception will be essential,” she says. “We’re trying to make sure there are more options available in the market because the responsibility for preventing pregnancy has rested squarely on women’s shoulders for so long.”

In addition to funding female birth control, her company is investing in Contraline, a Virginia-based biotech developing a reversible, non-hormonal form of male birth control. Contraline’s method involves a permeable hydrogel injected into the vas deferens, the pair of tubes in the male reproductive system that carry sperm. The gel is designed to block sperm without affecting sensation or ejaculation. The company is conducting a small Phase 1 trial in Australia to test the safety of the approach.

Your Choice Therapeutics and Eppin Pharma are also pursuing non-hormonal forms of male birth control. Your Choice develops a pill designed to block sperm from developing, while Eppin’s method is designed to prevent sperm from fertilizing an egg. But these companies have yet to move into human testing.

One of the hurdles to all of this effort will be regulatory approval for any product that passes Phase 3 trials. No male contraceptive has ever reached this stage, so the U.S. Food and Drug Administration must decide what level of risk is acceptable. Female birth control pills cause about one death in every 200,000 users, mainly from blood clots that can result from taking the pills. Men don’t have any of the physical risks of pregnancy, so calculating that risk-benefit balance will be difficult, Armory says. He believes this is one of the reasons pharmaceutical companies have been reluctant to get involved in male contraception. But ultimately, more contraceptive options would benefit everyone, he says: “The market is huge – we’re talking about potentially millions of men.”

With the fall of roe, Creinin believes it is time for the government to increase funding for male contraception research. “We are standing on the precipice of changing social norms,” ​​he says. “Whichever product launches first, it will be a social game changer.”

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