In an effort to develop a male birth control, The National Institutes of Health, or NIH, has begun clinic trials for a male contraceptive gel known as the brand name Nestorone, or NES/T, according to a press release from the National Institute of Child Health and Human Development, or NICHD. The NIH is seeking roughly 420 healthy couples who want to be part of the study.
The study will evaluate the contraceptive gel, which was created by the Population Council and NICHD over a span of more than a decade, to see how well it prevents pregnancy. The gel consists of the progestin compound segesterone acetate, as well as testosterone. It is designed to be absorbed through the skin.
“Many women cannot use hormonal contraception, and male contraceptive methods are limited to vasectomy and condoms,” said study investigator Diana Blithe, Ph.D., chief of NICHD’s Contraceptive Development Program, in a statement. “A safe, highly effective, and reversible method of male contraception would fill an important public health need.”
NES/T is massaged into the skin on the shoulders and upper arms. Once absorbed into the skin, “the progestin blocks natural testosterone production in the testes.” The study is to see how well the gel reduces sperm count or eliminates sperm levels all together. A normal sex drive should be maintained, while other functions also remain normal.
During the first phase of the study, male volunteers will use NES/T every day for four to 12 weeks. This is to ensure they are able to tolerate the contraceptive gel and show no adverse effects. The second phase of the study will test sperm count. Once sperm levels have fallen adequately, the male subjects will enter phase three of the trial. Phase three is approximately a year-long and will test the gel’s efficiency in preventing pregnancy, where the gel is the sole method of birth control. The final phase of the clinical trial is observing the male volunteers once they have discontinued using NES/T.
“Expanding male contraceptive options could help make family planning more of a shared responsibility between women and men,” said Regine Sitruk-Ware, MD, with the Population Council’s nonprofit Center for Biomedical Research and co-director of the trial in a statement by the Population Council.
“Safe, effective, and reversible tools for men to control their own fertility gives new meaning and significance to the term ‘family planning.’ No matter the challenge, we must continue to innovate and develop new products to improve lives.”
Results are expected in 2022.