CCTN- CONTRACEPTIVE CLINICAL TRIALS NETWORK - MALE SITES - NESTORONE AND TESTOSTERONE GEL

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Nestorone® gel (progestogen) in addition to testosterone (T) gel (androgen), both applied transdermally, has been shown to suppress gonadotropins and sperm production. Preliminary results from these studies indicate that a dose of 8 mg of Nestorone® gel is required in order to suppress gonadotropins sufficiently to a level that inhibits spermatogenesis. There are very few contraceptive options available to men. Studies indicate that men would use a safe and reversible method of contraception if one were available to them. One promising regimen involves a method of delivering androgen plus progestogen in order to suppress sperm production. The goal of the Task Order is to conduct a clinical trial to test whether Nestorone® gel (progestogen) and testosterone (T) gel (androgen), both applied transdermally, will be effective for contraception in couples who are willing to use the method as their primary method of contraception. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has a mission to develop safe and effective contraceptives for both men and women. Many women cannot use hormonal contraception and rely on their male partner to protect them from pregnancy. Current methods available for men are limited to vasectomy and condoms. Development of effective male contraceptive regimens remains a challenge for the field. In a clinical trial conducted in the NICHD Contraceptive Clinical Trials Network (CCTN), Nestorone® gel (progestogen) and testosterone (T) gel (androgen), both applied transdermally, was effective in suppressing gonadotropins and inhibiting spermatogenesis. The proposed study will be conducted in men in order to evaluate the safety and contraceptive efficacy of this regimen in couples who wish to avoid pregnancy and are willing to use the method as their primary method of birth control.