Program seeks Council approval for a recompete of an initiative titled “Biological Testing Facility (BTF).” This initiative spans both DIR and DER in research and development of safe and effective contraceptives for women and men.
In the United States, approximately 45% of all pregnancies are unintended. This rate is the highest among developed nations. Thus, there is a clear need for alternative and/or improved contraceptive methods that meet the requirements for both women and men throughout their reproductive lives.
The BTF with several cycles of history, fulfills a unique role in bridging the discovery to the development and approval of the contraceptive products. This facility provides in vitro and in vivo studies that are needed as part of preclinical data package necessary for filing an IND. The BTF provided preclinical data for numerous Phase 1 and Phase 2 clinical studies and an approved drug, ulipristal acetate. This facility is critical in manufacturing drug product, release, and stability testing under GMP protocol for clinical studies conducted by the Contraceptive Clinical Trials Network (CCTN).
The primary goal of this initiative is to develop novel and improved methods of contraception to fill the un-met needs. Thus, rigorous preclinical studies including GLP studies, formulation development, release, stability studies, and GMP manufacture of drug products are critical in providing preclinical data necessary to make progress toward the development of high quality, safe, and effective female and male contraceptive products.
This concept clearance is in alignment with the NICHD Strategic Plan Theme 2 in Promoting Gynecologic, Andrologic, and Reproductive Health and the Contraceptive Development Program’s priority on conducting translational and clinical research to develop novel methods of contraception for women and men.
This initiative addresses clear un-met needs when considering 45% of pregnancies in the United States are unintended.
Prior Progress: The BTF within the past several cycles have conducted numerous in vitro and in vivo studies encompassing binding and activity assays, androgenic, progestogenic, pharmacology, stability, safety, toxicology, and Good Laboratory Practice (GLP) studies. The critical contribution of the preclinical data from the BTF has resulted in an approved drug for two indications and ongoing phase 1 and phase 2 clinical trials. In more recent cycle, the BTF has manufactured numerous batches of different drug products from their in-house GMP facility. The BTF has provide several GMP batches of DMAU for po and im administration with follow on drug product stability studies. Their formulation group produced stable formulation for LB and applied this to manufacture two different batches of formulated LB for female contraceptive clinical trials carried out by the CCTN. This clinical trial is in Phase 2A. They have manufactured Nes/T gel for male contraception using two vendors. Through this mechanism, four batches of Nes/T gel were manufactured under GMP guidance in metered canisters. Phase 2B efficacy study for this product is almost complete. For both LB and Nes/T programs, patent applications have been filed. Additionally, it is expected that new batches of GMP LB and Nes/T investigational products will be provided by the BTF for continued clinical studies carried out by the CCTN.
The Contraceptive Infertility Target Database (CITDBase), a public resource was developed and is maintained through the BTF. The CITDBase (https://www.citdbase.org/ 
) is a curation of public databases for the purpose of providing a list of human REPRODUCTIVE SYSTEM/TISSUE SPECIFIC contraceptive targets for investigators working in the field. The goal of CITDBase is not only to identify potential contraceptive targets but, equally important, to foster collaborative efforts between the investigators from different areas of contraceptive and infertility research. This work was published in Biology of Reproduction (Sinha et. al., BOR, 2019,105,6, 1366-1374).
A new progestogenic-androgen (PA), 7a-methyltestosterone (7a-MT) as a potential male contraceptive agent is in preclinical stage with in vitro and in vivo studies encompassing binding and activity assays, androgenic, and progestogenic studies (Lee et. al., BOR, 2023, 109, 6, 851-863). Design and synthesis of potentially new contraceptive agents by Chemical Synthesis Facility (CSF) are ongoing and being tested by the BTF for their in vitro and in vivo activities.
Program Contact
Min Lee
Division of Population Health Research (DiPHR)
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