CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - MALE

University Of Washington, Seattle WA

Investigators

Abstract

SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS AND GONADOTROPIC SUPPRESSIVE EFFICACY OF COMBINATION NESTORONE AND TESTOSTERONE GEL IN MEN. PREPARATIONS ARE APPLIED TRANSDERMALLY Conduct a Phase Ib clinical trial to determine if the combination of drug formulation will efficiently suppress gonadotropin production. SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS AND GONADOTROPIN SUPPRESSIVE EFFICACY OF COMBINED NESTORONE® AND TESTOSTERONE GEL IN MEN? 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 progestin in order to suppress sperm production. Previous studies demonstrated the gonadotropin and sperm suppressing capability of Nestorone® gel and testosterone gel preparations applied transdermally. For the present study, both steroids have been combined into a single gel formulation. This Task Order is for the conduct of a Phase Ib clinical trial to test whether the combined Nestorone® and Testosterone gel product maintains similar pharmacokinetic and pharmacodynamic properties as were found for the two steroids in separate gel formulations. If a combination Nestorone® and T gel regimen is effective at gonadotropin suppression, the NICHD may elect to conduct a larger study to evaluate the product using contraceptive efficacy as the primary endpoint.