CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - CORE - FEMALE

Magee-Women'S Res Inst And Foundation, Pittsburgh PA

Investigators

Abstract

The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), is the lead Federal agency for the conduct of basic, clinical research to develop new contraceptives and to evaluate existing methods of contraception and reproductive health. NICHD has long supported several preclinical contraceptive testing facilities as well as facilities for synthetic chemical and synthetic peptide formulation. To further expand their contraceptive development capabilities, in 1996 NICHD established the NICHD Contraceptive Clinical Trials Network (CCTN). The current CCTN has conducted Phase I, II, and III clinical trials of both female and male contraceptive methods. With the recompetition of the CCTN, clinical sites will perform Phase I, II, III, and Phase IV clinical trials of a wide variety of new or existing female contraceptive methods. The purpose of this contract is to systematically evaluate the safety and efficacy of new female contraceptive drugs and devices as well as gynecologic conditions, such as endometriosis or leiomyoma, in Phase I, II, III, and IV trials.