CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - FEMALE SITES

Ut Southwestern Medical Center, Dallas TX

Investigators

Abstract

To conduct Phase I, II, III or IV contraceptive trials in women, treatment trials of gynecologic conditions such as endometriosis or leiomyomata, and development of research protocols on a task order basis under a seven (7) year Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract. The resultant contracts will provide a network of clinical trial sites that will evaluate systematically the safety and efficacy of new or existing female contraceptive drugs and devices as well as drug treatments of gynecologic conditions in Phase I, II, III, and IV trials. The results of these clinical trials on new or existing entities would be the basis for advancing candidate drugs and devices through development with the ultimate goal of submission to the Food and Drug Administration (FDA) in support of a New Drug Application (NDA).