Breakthrough male contraceptive gel shows rapid results in clinical trial

By Lily Ramsey, LLMJun 3 2024

A new male contraceptive gel, combining two hormones, has demonstrated faster suppression of sperm production compared to previous experimental methods, according to recent study findings. The results of this ongoing multicenter phase 2b clinical trial will be presented at the Endocrine Society's annual meeting, ENDO 2024, in Boston.

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Revolutionizing male contraception

Senior researcher Diana Blithe, Ph.D., who leads the Contraceptive Development Program at the National Institutes of Health (NIH), emphasized the importance of this development. "The development of a safe, highly effective, and reliably reversible contraceptive method for men is an unmet need," she stated. Blithe pointed out that while some hormonal agents have shown potential, their slow onset in suppressing sperm production has been a significant drawback.

Study details and findings

Funded by the NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development, the study involved 222 men who completed at least three weeks of daily treatment with the contraceptive gel. The gel consists of 8 milligrams (mg) of segesterone acetate, an ingredient also used in the Annovera vaginal birth control ring, and 74 mg of testosterone. Participants applied the gel once daily to each shoulder blade.

Researchers measured sperm production at four-week intervals, defining effective contraception as a sperm count of one million or fewer per milliliter of semen. By week 15, 86% of participants achieved this level of suppression, with a median suppression time of less than eight weeks. This is a significant improvement over prior methods, where hormonal contraceptives given by injection took between nine and 15 weeks to achieve similar results.

"A more rapid time to suppression may increase the attractiveness and acceptability of this drug to potential users," Blithe noted. The addition of segesterone acetate to testosterone not only accelerated sperm suppression but also allowed for a lower dose of testosterone, maintaining normal sexual function and other androgen-dependent activities.

Broader implications

The rapid suppression of sperm production is a key advantage of this new gel, potentially increasing its appeal to users. The ongoing phase 2b trial will continue to assess the gel's effectiveness, safety, acceptability, and the reversibility of contraception after treatment stops.

Testosterone treatment alone decreases sperm production, with a median time of 15 weeks. However, the combination of segesterone acetate speeds up the suppression time and reduces the necessary dose of testosterone. In the daily segesterone-testosterone gel regimen, blood levels of testosterone are kept in the physiologic range, ensuring the maintenance of normal sexual function and other androgen-dependent activities.

Future outlook

As the trial progresses, further insights will emerge regarding the long-term viability and market potential of this contraceptive gel. Its success could pave the way for future innovations in male contraception, addressing a significant gap in reproductive health options for men.

For more detailed findings, keep an eye on updates from the Endocrine Society’s annual meeting and subsequent publications.

Conclusion

This innovative gel represents a significant step forward in male contraceptive methods, promising faster and more effective suppression of sperm production. With continued research and development, it holds the potential to become a widely accepted option, offering men greater control over their reproductive health.