This issue
There is a growing interest and willingness among men in becoming more involved in family planning and studies suggest that women would welcome male contraceptive choices. However, men have no contraceptive options other than vasectomy or condoms.
The development of effective male options is a challenge because the success of male hormonal contraception depends on near complete suppression of sperm production while maintaining healthy testosterone levels to maintain a man’s sexual drive (libido). A safe, effective, acceptable, reversible contraceptive for men requires an approach that will suppress sperm count in a well-defined period of time (e.g., ≤12 weeks) while maintaining testosterone levels in the normal range.
The Progress
Together with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the Population Council has developed a once-daily topical gel combining Nestorone®, a synthetic progestin, and testosterone to suppress sperm production while maintaining normal testosterone levels. A Phase 2b clinical trial was successfully completed among 462 couples including sites across the United States, South America, Europe, and sub-Saharan Africa. In clinical trials, men were instructed to apply the gel once daily to the shoulders and upper arms where it is absorbed through the skin.
The Council has executed a global, exclusive license agreement for the gel with Contraline Inc., a clinical-stage biotechnology company. Contraline has begun actively planning a pivotal Phase 3 clinical program, which is expected to be the first Phase 3 trial of a hormonal male contraceptive in history.
The Impact
The Nestorone/Testosterone gel (NES/T) is the most advanced investigational male contraceptive to date, demonstrating strong potential for safety, efficacy, reversibility, and patient acceptability. Steady delivery of Nestorone®/Testosterone gel through the skin would be an easy-to-use, reversible contraceptive method controlled by men. If approved by regulatory authorities, the Nestorone®/Testosterone gel would be the first-of-its-kind male contraceptive, providing a meaningful expansion of family planning options worldwide.
For more information, please visit https://www.contraline.com/nestorone.
