COORDINATION, MONITORING, FOLLOW-UP, EVALUATION, AND COMPLETION OF A CLINICAL TRIAL OF NESTORONE TESTOSTERONE GEL FOR MALE CONTRACEPTION

Health Decisions, Inc., Durham NC

Investigators

Abstract

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has a mission to develop safe and effective contraceptives for women and for men. The Contraceptive Clinical Trials Network (CCTN) was established to provide qualified sites the ability to perform clinical trials of new products, including a Statistical and Clinical Coordinating Center (SCCC). The purpose of this Task Order is to conduct work required and to provide the appropriate deliverables associated with the completion of a clinical trial designed to evaluate the daily application of a Nestorone and Testosterone combination gel for male contraception. The current options for men are limited to condoms for reversible contraception or vasectomy for contraception that has very limited reversibility. The objective of this Task Order is to provide support for the conduct and completion of a multi-site clinical trial of the Nestorone Testosterone Gel for use as a novel male contraceptive product. The goal of the current Phase IIB study, CCN017, is to demonstrate safety, sperm suppression and contraceptive efficacy when the product is used by the male partner.