Gel formulation of a new male contraceptive on trial

By Dr. Ananya Mandal, MDNov 29 2018

The National Institutes of Health (NIH) is funding a clinical trial to see the safety and effectiveness of a new male contraceptive that would be available in gel formulation.

Male contraception has been a challenge for decades now. Barrier contraception such as condoms on one hand and permanent contraception vasectomy on the other. Most men are reluctant to adopt contraception for the sake of contraception and preventing unwanted pregnancies mainly because they do not get pregnant!

Condom use still has added advantages of protection against sexually transmitted infections and thus has a market, other forms of contraceptives for males have been developed and failed over the years.

This new method of contraception for males could be a mid-ground between condoms and vasectomy say the researchers. Dr. William Bremner of the University of Washington School of Medicine, part of the team testing the new gel form said however, “The potential of this new gel is huge. There is a misperception that men are not interested in, or are even afraid of, tools to control their own fertility. We know that’s not the case.”

The gel formulation of the contraceptive was developed by the Population Council and the NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) team. In the clinical trial planned, the method would be tested on 420 couples to see if it could prevent pregnancies. The Population Council in a statement said, “Worldwide, 85 million pregnancies (40 percent of all pregnancies) per year are unplanned, contributing to a higher incidence of adverse health outcomes for women and infants.”

The active ingredient in the contraceptive is called NES/T (Nesterone), a progestin compound segesterone acetate along with male hormone testosterone. It can effectively block the production of testosterone in the testes and thus reduce the sperm count in the men. It is at present approved by the United States Food and Drugs Administration (US FDA) as a hormonal contraceptive as well as used in treatment of endometriosis in women.

The participating men would be spraying the formulation or the gel over their back and shoulders from where it will be absorbed. In the phase 2b clinical trial two sites have been chosen. These are a couple of NICHD Contraceptive Clinical Trials Network sites in Los Angeles and Seattle. The male volunteers would use the contraceptive for a period of 4 to 12 weeks once a day. Side effects, tolerability as well as sperm levels would be noted.

The treatment would continue for up to 16 weeks if the levels of the sperm counts have not declined with use. After the sperm count reaches the desired low levels the participants would enter a 52 week trial phase.

During this phase the couple would have just the gel contraceptive as the only method of contraception. After the 52 week trial phase the couple would be observed for a period of 24 weeks without the contraceptive to check on the sperm counts and other parameters.

Investigator and NICHD Contraceptive Development Program chief Diana Blithe, PhD, said in a statement said, “Many women cannot use hormonal contraception and male contraceptive methods are limited to vasectomy and condoms. A safe, highly effective and reversible method of male contraception would fill an important public health need.”

The study is expected to be completed by July 2021.