www.optimistdaily.com
First hormone-free male birth control pill shown safe in early trial
BY THE OPTIMIST DAILY EDITORIAL TEAM
For decades, the burden of birth control has largely fallen on women. Pills, implants, IUDs, injections; the options are many, but they all target the female reproductive system. Meanwhile, male contraceptives have remained stuck in the basics: condoms or vasectomy. Now, that could be changing.
A new hormone-free male birth control pill called YCT-529 has cleared its first human safety trial, offering a hopeful step toward a broader and more equitable range of contraceptive choices. The results, published in Communications Medicine, indicate that the oral medication is well-tolerated in healthy participants and could become a viable, reversible option for men in the future.
“We really need more reversible contraceptive methods for men,” said Stephanie Page, an endocrinologist at the University of Washington School of Medicine, who was not involved in the trial but has worked on male contraceptives for over 20 years.
How YCT-529 works
Unlike hormonal methods that rely on testosterone or progestin, YCT-529 takes a different approach. It blocks a vitamin A metabolite from binding to receptors in the testes, a critical step in initiating sperm production. This targeted mechanism allows the pill to suppress sperm creation without affecting hormones linked to mood, libido, or sexual function, presenting a potential advantage over hormone-based options.
The goal is reversibility: take the pill, pause sperm production; stop the pill, and fertility gradually returns. But this trial wasn’t designed to measure efficacy just yet. Instead, it focused solely on safety and how the body absorbs and processes the drug.
Trial design and early findings
The phase 1 clinical trial enrolled 16 healthy men aged 32 to 59, all of whom had previously undergone vasectomies. This extra safeguard ensured that even if the pill unexpectedly affected fertility, it wouldn’t pose a risk to participants. The trial was overseen by YourChoice Therapeutics, the company developing YCT-529.
Participants were divided into two groups. One group received 10- and then 30-milligram doses of the drug; the other received 90- and then 180-milligram doses. Placebos were given to some in each group. A few participants also tested how food affected absorption by taking the pill after a high-fat breakfast.
“We saw good and quick bioavailability,” said Nadja Mannowetz, chief science officer and co-founder of YourChoice Therapeutics. Blood levels of the drug dropped by half in about two to three days, suggesting it could be effective as a once-daily pill.
Most notably, no adverse side effects linked to the drug were observed. Mannowetz added that, since the pill is hormone-free, there’s theoretically less risk of mood changes or sexual dysfunction, which are common concerns with hormonal contraceptives.
What’s next?
Efficacy trials are now underway to test whether YCT-529 reliably reduces sperm counts and to determine the optimal dosage for real-world use. Mannowetz expects the final approved dose to be closer to the higher levels tested in the study, around 180 milligrams.
Though early, these findings could signal a shift. “It would be overstating the data to say they know much about side effects yet,” Page cautioned, but she acknowledged the results are promising. “Every medication on the market has side effects.”
A growing pipeline of male contraceptives
YCT-529 isn’t alone in the race. NES/T, a gel containing testosterone and the progestin Nestorone, is further along in clinical development. Users apply the gel to their shoulders and arms daily. Like YCT-529, NES/T takes about three months of daily use to suppress sperm production, with fertility returning roughly three months after stopping.
Other innovations are in the works as well. Hormonal male birth control pills are in early-stage research, and a non-hormonal hydrogel implant called ADAM is being tested as a reversible, physical block in the vas deferens, essentially a temporary vasectomy.
Public interest is high
Surveys suggest a strong interest among men for new contraceptive options. A 2023 study found that 75 percent of more than 2,000 men in the U.S. and Canada were open to trying new male birth control. Another 2019 report found nearly half of U.S. men aged 18 to 49 who were sexually active but not seeking pregnancy said they would be “very interested” in novel contraceptives.
“Men are very eager to have more reproductive agency and to participate in contraception,” Page said. With several approaches moving through clinical trials, the future of male birth control could be one where shared responsibility is finally built into the system.
Source study: Communications Medicine— Safety and pharmacokinetics of the non-hormonal male contraceptive YCT-529The post First hormone-free male birth control pill shown safe in early trial first appeared on The Optimist Daily: Making Solutions the News.