Last Update: 09/11/2006 Printer Friendly Printer Friendly   Email This Page Email This Page  

Cooperative Research Program on Male Fertility Regulation

Doctor and male patientDeveloping contraceptives for males is among the goals of the NICHD strategic plan, Reproductive Health in the 21st Century. In order to implement that plan, the Contraception and Reproductive Health Branch, in collaboration with the other Branches in the Center for Population Research (CPR), has initiated or restructured existing programs to encourage a spectrum of activities leading to development of male contraceptives, including a combination of basic, applied, and clinical research. These programs include the following:

  • Redirection of the Contraceptive Development Research Centers, which focus on basic and clinical contraceptive research (see previous section), to include a number of projects devoted specifically to male contraception.
  • Support of a Fertility Defect Phenotyping Program (currently at Baylor University and Northwestern University). Supervision of this Program resides in the Reproductive Sciences Branch of the CPR, and it is part of a collaborative effort involving the Male Fertility Regulation Cooperative Agreement described in the next bulleted item.
  • Support of solicited Male Fertility Regulation Cooperative Agreements to elucidate novel contraceptive methods for males. Of the 33 applications that were reviewed, eight were recommended for funding. The PIs will form a steering committee to foster communication among the participants, review progress within the individual projects, and make recommendations regarding future directions of the projects. The anticipated period of support for these agreements is 2003 through 2008. The investigators and projects included in this program are:
  • Utilization of existing contracts for Chemical Synthesis and Peptide Synthesis Facilities to synthesize bulk quantities of drugs, under current Good Manufacturing Practices, for use in clinical trials. These contracts will assist in the conduct of translational research by scaling-up synthesis of specific male contraceptive agents that have been identified as candidates for clinical trials.
  • Utilization of Biological Testing Facilities to conduct biological evaluation and toxicology testing prior to utilization of promising male agents in clinical trials approved by the U.S. Food and Drug Administration.
  • Funding of clinical sites within the Contraceptive Clinical Trials Network that are capable of conducting Phase I, II, or III clinical trials in males. Sites have been selected and the contracts are currently in negotiation.