NIH Survey of gel formulation as a male contraceptive once a day

A new clinical trial funded by the National Institutes of Health (NIH) will evaluate a new concept of male contraception that could provide support between condoms and vasectomy procedures.

A male contraceptive gel formulation, developed by the Population Council and the NIHD (National Institute of Child Health and Human Development) team at NIH Eunice Kennedy Shriver, will be evaluated for its ability to prevent pregnancy in the context of from a next try involving up to 420 couples.

NES / T (Nesterone), a testosterone-badociated progestagen acetate compound, has been designed to block the natural production of testosterone in the testes, reducing sperm production in men at low or no rates. The drug is currently approved in the United States for use as a hormonal contraceptive, as well as for the treatment of endometriosis.

The investigational gel is absorbed through the skin, when applied to the back and shoulders.

The prospective Phase 2b study, which will be conducted at two sites of the NICHD contraceptive clinical trial network in Los Angeles and Seattle, will allow observation of NES / T gel in male volunteers for 4 to 12 weeks. . The once-daily formulation will be observed for tolerance and unplanned side effects, as well as sperm levels. Participants will continue gel treatment until 16 weeks if sperm levels have not decreased adequately.

Once participants' sperm levels reach a level sufficient for the gel to be considered a contraceptive, they enter a 52-week trial phase during which the couple relies solely on the gel to take contraceptive measures. .

An additional observation period of 24 weeks will be carried out once the participants have stopped the formulation.

The NIH did not immediately respond to the request for comments on the study. NICHD researcher and head of the NICHD Contraceptive Development Program, Diana Blithe, PhD, said in a statement that many women were unable to use hormonal contraception, while the methods used by men were severely limited.

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

According to the ClinicalTrials.gov study page, the completion date for its main goal is scheduled for July 2021.