Promising Safety Results for Innovative Non-Hormonal Male Birth Control Pill

Recent clinical trials have demonstrated that a novel non-hormonal male contraceptive, YCT-529, appears safe and well-tolerated in early human testing. Conducted by YourChoice Therapeutics in collaboration with Quotient Sciences and Incyte, this study involved 16 healthy men aged 32 to 59, with doses up to 180 mg administered in capsule form. The trial aimed to evaluate safety, tolerability, pharmacokinetics, and initial effects on reproductive hormones.

Participants received a single dose of YCT-529 or a placebo, with extensive monitoring including ECGs, blood analyses, and assessments of mood, libido, and inflammation markers. No significant adverse events or severe side effects were reported. A transient, asymptomatic arrhythmia was observed in one subject at higher doses but was deemed non-clinically significant after thorough evaluation. Regulatory safety thresholds related to cardiac function remained within acceptable limits.

Pharmacokinetic data showed that serum drug levels achieved in this study correlated with doses known to reduce sperm production in animal models, without impacting hormone levels such as testosterone or affecting mood and sexual performance. Interestingly, the drug's exposure levels increased with food intake, although variability limited interpretations.

This pivotal trial marks a significant step toward developing a reversible, non-hormonal male contraceptive. A subsequent longer-term study is ongoing to assess the effects over 28 and 90 days, aiming to establish a safe, effective, and widely accessible male contraception option. The results may eventually provide men with a reliable alternative to condoms or vasectomy, addressing a global need for more diverse family planning methods.

Source: https://medicalxpress.com/news/2025-07-male-birth-pill-safety-hurdle.html