NIH Investigating Gel Formulation as Once-Daily Male Contraceptive

A new National Institutes of Health (NIH)-funded clinical trial will evaluate a new male contraceptive concept that could provide a medium between condoms and vasectomy procedures.

A male contraceptive gel formulation, developed by the Population Council and the NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) team, will be assessed for its ability to prevent pregnancy in an upcoming trial involving up to 420 couples.

NES/T (Nesterone), a progestin compound segesterone acetate in combination with testosterone, was designed to block natural testosterone production in the testes, thereby reducing men’s sperm production to low or nonexistent rates. The medication is currently approved in the US for use as a hormonal contraceptive, as well as for the treatment of endometriosis.

The investigative gel is absorbed through the skin, once applied to the back and shoulders.

The prospective, phase 2b study—which will be conducted at a pair of NICHD Contraceptive Clinical Trials Network sites in Los Angeles and Seattle, will observe the NES/T gel in male volunteers for 4-12 weeks. The once-daily formulation will be observed for tolerability and unforeseen side effects, as well as sperm levels. Participants will continue the gel treatment for up to 16 weeks if sperm levels have not adequately declined.

Once participant’s sperm levels reach a level sufficient to deem the gel as having been contraceptive, they will enter a 52-week trial phase, wherein the couple will solely rely on the gel for contraceptive measures.

A supplemental 24-week observation period will be conducted once participants discontinue the formulation.

The NIH did not immediately reply to request for comment on the study. Investigator and NICHD Contraceptive Development Program chief Diana Blithe, PhD, noted in a statement how many women are incapable of using hormonal contraception, while men’s methods are severely limited.

“A safe, highly effective and reversible method of male contraception would fill an important public health need,” Blithe said.

According to the study’s page on ClinicalTrials.gov, its anticipated primary endpoint completion date is July 2021.