CDP efforts focus on conducting translational and clinical research to develop novel methods of contraception for women and men.
Using research and development contracts, CDP researchers translate discoveries into investigational new drug (IND)-enabled products and conduct clinical evaluation to address unmet contraceptive needs of women and men. The program also utilizes technology transfer mechanisms to form partnerships to advance products toward regulatory approval.
CDP supports a Chemical Synthesis Facility to synthesize clinical-grade, active pharmaceutical ingredients that are not commercially available; a Biological Testing Facility that performs preclinical testing to qualify agents for studies approved by the U.S. Food and Drug Administration (FDA); and the Contraceptive Clinical Trials Network (CCTN), which conducts clinical evaluation of new contraceptives for women and for men. CDP scientists coordinate and integrate program components to produce groundbreaking contraceptive research.
CDP’s mission addresses multiple scientific themes and cross-cutting topics within NICHD’s Strategic Plan. New and better female methods as well as the first reversible, effective contraceptive method for men fall into Theme 2: Promoting Gynecologic, Andrologic, and Reproductive Health. But they also are tools to help reduce health disparities, prevent infectious and other diseases, treat chronic conditions, and improve global health.
- Chemical Synthesis in Discovery and Development of New Chemical Entities (NCEs) for Clinical Evaluation: To support clinical development, the program conducts in vitro and in vivo translational studies of synthesis in discovery and optimization of NCEs. NCE clinical studies are conducted under an IND application, potentially leading to a New Drug Application. NCEs 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 NCEs required for the program.
- Preclinical Qualification of Drugs or Devices Prior to Clinical Evaluation: NCEs require toxicology testing to demonstrate safety. IND-enabling preclinical studies must be performed under Good Laboratory Practice and meet regulatory standards. Human trials require formulation and release of contraceptive agents under cGMP, and stability studies cover 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.
- Contraceptive Clinical Trials Network (CCTN): The CCTN evaluates safety and efficacy of new contraceptive drugs and devices for women and men. Results of these clinical trials form the evidence base for advancing candidate drugs and devices through development toward FDA approval. The CCTN includes 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 also serve as the training ground for the next generation of contraceptive investigators.
- New Contraceptive Methods: Contraceptive product development is challenging. Once a candidate is identified, about 10% pass preclinical screening to enter clinical testing, and only 12% of those products complete Phase III and FDA submission. Because contraceptives are used by healthy people for long durations, long-term safety is critical. CDP has a pipeline of products in clinical evaluation, including hormonal or non-hormonal options for women and novel hormonal methods for men. Each product is developed to fill an unmet need or provide greater safety to vulnerable populations at risk of unintended pregnancy.
Interview with Dr. Blithe (MP4 67 MB) at the 15th Congress of the European Society of Contraception and Reproductive Health – How do hormonal methods control sperm production?
Long, J. E., Lee, M. S., & Blithe, D. L. (2021). Update on novel hormonal and non-hormonal male contraceptive development. The Journal of Clinical Endocrinology and Metabolism 106(6), e2381-e2392. PMID: 33481994
Watch Dr. Blithe present on “Prospects and Pipeline for Male Contraception” at the 2017 Nobel Conference 53: Reproductive Technology: How Far Do We Go?