Development of novel contraceptive methods for men and women

Eunice Kennedy Shriver National Institute Of Child Health & Human Development

Investigators

Linked publications, trials & patents

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. A new Cooperative Research and Development Agreement (CRADA) was negotiated and approved in 2021. The goal of the CRADA is to conduct clinical efficacy studies on a novel vaginal shield that would provide a full month of non-hormonal contraceptive activity. The protocol for the clinical trial is under development and the trial is planned to begin in Q4 2023. A Phase IIb trial of a novel hormonal male contraceptive gel is being evaluated in couples who agree to use the method for contraception. The trial is ongoing and preliminary results show high efficacy and acceptability of the product in both partners in the couple. The trial continues with completion scheduled for Q4 2024. A Phase IIa trial of a novel injectable contraceptive for women is being evaluated to find the optimal dose. The trial shows long-acting efficacy and high acceptability. The trial continues with dose escalation to determine duration of activity. Trial completion is scheduled for Q3 2024. Interactions with potential commercial partners is underway.