Launch of first clinical trial for male contraceptive gel

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In November 2018, the Population Council, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the Los Angeles Biomedical Research Institute, and University of Washington School of Medicine announced that three sites in the United States started enrolling couples in the first-ever clinical trial to test the safety and efficacy of a gel for men to prevent unintended pregnancy. More than 400 couples are anticipated to enroll in the trial, and each will agree to using a gel composed of Nestorone ® (segesterone acetate), a progestin hormone, and testosterone as their only form of contraception for one year.

The “NES/T” is a transparent gel that will be absorbed through the skin on a male’s upper arms and shoulders. Not only is it projected to be reversible in that it will not affect a man’s ability to produce sperm at a later date, but it is also designed to temporarily decrease a man’s sperm production without impacting his testosterone levels, or reducing his sexual drive or enjoyment.

No contraceptive options for men currently exist beyond condom use, withdrawal during sex, and vasectomy. Findings from this clinical trial could help revitalize research interest in male contraceptive development. Results from the trial are expected to be published in 2022.

Written by Katelyn Jones, Fellow, Contraceptive Technology Innovation Exchange

 

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