Development of novel contraceptive methods for men and women

Eunice Kennedy Shriver National Institute Of Child Health & Human Development

Investigators

Linked publications & trials

Abstract

CDP uses R&D contracts to achieve the goal of new method development. The Program evaluates new drugs that are not commercially available and must be synthesized under current Good Manufacturing Practice (cGMP) that comply with all regulatory standards of Chemistry, Manufacturing and Controls. CDP maintains a contracted Chemical Synthesis Facility to produce novel drugs required for the program. Potential new drugs and devices require toxicology testing to demonstrate safety. IND-enabling preclinical studies must be performed under Good Laboratory Practice (GLP) meeting regulatory standards. Human trials require formulation and release of agents under cGMP, and stability studies covering the duration of the trial. CDP maintains a Biological Testing Facility to perform preclinical evaluation and batch preparation required for first-in-human studies and longer toxicology studies for later Phase clinical trials. Clinical evaluation of the novel products occurs in the Contraceptive Clinical Trials Network (CCTN) under the Program Management of the CDP. The CCTN evaluates safety and efficacy of new contraceptive drugs and devices for women and for men. Results from clinical trials on new entities form the basis for advancing candidate drugs and devices through development with the goal of FDA regulatory approval. The CCTN comprises top clinical investigators at qualified institutions, including both domestic and international sites, with expertise to conduct all phases of contraceptive evaluation, from first-in-human through Phase III. The clinical sites serve as the training ground for the next generation of investigators in the field.