Program seeks Council approval for an initiative to support the manufacturing of high quality candidate drug substances being tested in protocols conducted by the Contraception Clinical Trials Network.
The United States has a greater proportion of unintended pregnancies than other wealthy or industrialized countries. Approximately 50% of all pregnancies in United States are unintended. There is a clear need for alternative contraceptive methods that meet the requirements for both women and men throughout their reproductive lives.
The development of new and/or improved contraceptive methods is a primary goal of Contraception Research Branch (CRB). The NICHD, through the CRB, is the world leader in contraceptive research and development. CRB is unique within the NICHD in that a significant proportion of its activities and expenditures are dedicated to the development of novel and improved therapeutics (contraceptives). To develop novel and improved methods of contraception, rigorous preclinical and clinical evaluations are required. These studies must be conducted with candidate drugs produced via rigorous and controlled manufacturing processes (i.e., current Good Manufacturing Practice (cGMP)).
The goal of this initiative is to ensure continuous manufacture and supply of contraceptive drug substance produced under cGMP methods to support ongoing and planned contraceptive clinical trials in support of CRB’s mission. In the near term, we must manufacture additional Dimethylandrolone Undecanoate (DMAU), a candidate male contraceptive in phase I within the CRBs male Contraceptive Clinical Trial Network. Additional molecules will be produced to support the production of other contraceptive agents for clinical development.
This initiative is a renewal. Currently, the institute is supporting such manufacturing which is capable of producing cGMP production of gram scale synthesis to large scale (<10kg) manufacture of contraceptive drug substance under cGMP protocol. It is anticipated that this type of production will continue to be needed over the next five years.
This proposed concept aligns with the NICHD Vision areas of Reproduction.
Program Contact
Min Lee
Contraception Research Branch
Back to Concept Review by Council
BACK TO TOP