Breakthrough In Male Birth Control As Hormone-Free Pill Passes Human Safety Test

Researchers have been working on experimental hormone-free male birth control pills, with its first safety test in humans just passed in a breakthrough. The latest results from the early phase 1 clinical trial were published on Tuesday in Communications Medicine.

The daily pill, called YCT-529, works by blocking a vitamin A metabolite from binding to its receptor in the testes. It prevents sperm production without affecting hormone levels, the study revealed.

The phase 1 clinical trial was conducted on 16 healthy men who had undergone vasectomies. The results showed that the drug was well-tolerated with no serious adverse events reported.

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The optimal dosage is expected to be around 180 mg, based on the trial results. However, further studies will determine the exact dosage. The trial did not assess the pill's efficacy in reducing sperm and preventing pregnancy, with the medicine developer, YourChoice Therapeutics, running trials to collect that data.

However, Dr Stephanie Page, an endocrinologist at the University of Washington School of Medicine, who wasn't involved in the study, said that the safety finding is a crucial milestone. "We really need more reversible contraceptive methods for men," Page said as quoted by Scientific American.

Animal studies have shown that fertility returns within 4-6 weeks after stopping the drug in mice and 10-15 weeks in non-human primates.

The pill would provide a safe, reversible and non-hormonal alternative to current male birth control methods, such as condoms and vasectomies.

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"A safe and effective male pill will provide more options to couples for birth control," Gunda Georg, who is a professor in the University of Minnesota College of Pharmacy, said in a statement. The drug molecule was developed there. "It will allow a more equitable sharing of responsibility for family planning and provide reproductive autonomy for men."

The pill is currently in phase 2 clinical trials. It may take several years to become available on the market, if it gets approval. Other options in development include NES/T, a hormonal gel, and ADAM, a hydrogel implant that acts as a reversible vasectomy.

"The positive results from this first clinical trial laid the groundwork for a second trial, where men receive YCT-529 for 28 days and 90 days, to study safety and changes in sperm parameters," the study authors wrote in their paper.