UC Davis Health is testing a potential new birth control option that could lead to the first male hormonal birth control on the market.
The National Institutes of Health (NIH) is funding a reversible male contraceptive gel study that has advanced to Phase 2 testing. UC Davis Health in Sacramento is a clinical trial site. Other U.S. testing sites include Los Angeles, Seattle, Kansas City, Portland, Norfolk and Philadelphia, along with worldwide locations in England, Scotland, Italy, Sweden, Kenya and Chile.
The gel formulation was developed by the Population Council and NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
“Many women cannot use hormonal contraception, and male contraceptive methods are limited to vasectomy and condoms,” said study director Diana Blithe, chief of NICHD’s Contraceptive Development Program. “A safe, highly effective and reversible method of male contraception would fill an important public health need.”
The two-year study aims to enroll at least 12 healthy couples at UC Davis. Eligibility criteria include the following:
- Men must be between the ages of 18 and 50.
- Women must be between the ages of 18 and 34 years and have regular menstrual cycles.
- Couples do not need to be UC Davis Health patients to participate.
Once couples complete screening visits, the man will start using the study contraceptive gel daily. The study contraceptive gel comes in a pump that provides a standard amount (about one teaspoon) with each use. The man rubs the study contraceptive gel onto his shoulders. The gel contains segesterone acetate, a synthetic progestin, which blocks natural testosterone production in the testes and reduces sperm production. The gel also contains replacement testosterone to help maintain normal sex drive and other functions dependent on the hormone.
A man’s sperm count should be low enough to prevent pregnancy in about four months, but it can take up to six months. At that point, the couple will use the study contraceptive gel as their only form of birth control for 12 months. The man will have monthly checkups over the course of the trial, with sperm count testing and testosterone monitored at each visit. The female partner will have checkups every three months.
After 12 months, the man will stop using the study contraceptive gel and will continue to be followed until his sperm count returns to the normal range, which typically takes about four months.
“We’re excited to be one of the new sites studying male contraception. We have been widely involved in developing new female birth control methods at UC Davis and know, from our patients, that a male method is highly desired by both men and women,” said Mitchell Creinin, director of family planning and lead study investigator at UC Davis Health. “The study allows us to follow each man’s testosterone levels closely to make sure he is getting enough testosterone, and we can even give him more to make sure his energy level won’t change. We can all feel excited to be closer to having a male method other than condoms and vasectomies.”