UC Davis seeks 12 couples to test hormonal birth control gel for men
UC Davis Health is looking for 12 healthy couples to test out a new birth control method for men that could become the first male hormonal contraceptive on the market.
The contraceptive comes in the form of a gel, and men rub about a teaspoon-size dollop of it on their shoulders each day. Its effects are reversible, UC Davis researchers said.
“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 gel contains a synthetic version of the hormone progestin. Called segesterone acetate, it blocks natural production of testosterone in the testes and reduces sperm production. The gel also contains replacement testosterone that will help to maintain normal sex drive and other functions that depend on the hormone.
About four to six months after starting the gel, a man’s sperm count should be low enough to prevent pregnancy, researchers said, and once that goal is achieved, the couple will use the contraceptive gel as their only form of birth control for 12 months.
If selected, couples will receive up to $4,125 to participate in the two years of the trial. UC Davis is seeking couples who fit the following criteria:
Men must be ages 18 to 50.
Women must be ages of 18 to 34 and have regular menstrual cycles.
Couples do not need to be UC Davis Health patients to participate.
Men chosen for the study 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.
“The study allows us to follow each man’s testosterone levels closely to make sure he is getting enough testosterone,” said Mitchell Creinin, director of family planning and lead study investigator at UC Davis Health, “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.”
The gel was proven safe in the first phase of testing on humans, and it has now advanced to Phase 2 where researchers will evaluate the drug’s effectiveness. Funded by the National Institutes of Health, the two-year clinical trial also will have subjects in other U.S. cities such as Los Angeles and Philadelphia. as well as in nations including England, Scotland, Italy, Sweden, Kenya and Chile.
The formula for the gel was developed by the Population Council and NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development.
“We’re excited to be one of the new sites studying male contraception,” Creinin said. “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.”
If interested in participating, couples can call 916-734-6846 or email hs-obgynresearch@ucdavis.edu. Need more information? Visit https://studypages.com/s/join-a-research-study-of-a-potential-new-form-of-male-birth-control-943837/.
