The CONRAD Clinical Research Center in EVMS Obstetrics and Gynecology is one of 12 international clinical sites testing an innovative option that could lead to the first male hormonal birth control method on the market.
“Many women cannot use hormonal contraception, and male contraceptive methods are limited to vasectomy and condoms,” says study director Diana Blithe, Chief of the National Institute of Child Health and Human Development's Contraceptive Development Program. “A safe, highly effective and reversible method of male contraception would fill an important public health need.”
The goal of this two-year study is to enroll at least 12 healthy couples at the CONRAD Clinical Research Center. 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 EVMS patients to participate.
Once couples complete screening visits, the man will start using daily the contraceptive gel. The study contraceptive gel comes in a pump that provides a standard amount (about one teaspoon) with each use. The gel is applied to both shoulders. It contains segesterone acetate (Nestorone®), a synthetic progestin, which blocks natural testosterone production from the testes and reduces sperm production. The gel also contains replacement testosterone to help maintain normal sex drive and erectile potency.
The sperm count usually takes less than four months to be low enough to prevent pregnancy, but it can take up to six months. When the sperm count reaches a predetermined low value, 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.
Nestorone® has been tested and shown to be safe in over 3,000 women, and it has FDA approval as a female contraceptive. Nesterone has been tested in 287 men in four prior studies conducted at Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the University Of Washington School of Medicine with no major safety concerns identified.
Couples who participate for the full two-year clinical trial will receive up to $2,885. For more information or to sign up, call 757.446.5808 or email firstname.lastname@example.org.
The other clinical sites within the United States include Los Angeles, Seattle, Kansas City, Portland and Philadelphia, along with worldwide locations in England, Scotland, Italy, Sweden, Kenya and Chile.