BIOMEDICINE
Product Research and Development:
Contraceptives

Population Council biomedical scientists are engaged in every aspect of contraceptive development. They identify new drugs and delivery systems. They undertake the requisite animal and preclinical research. They analyze clinical findings. And they submit documentation of results to regulatory authorities for permission to conduct human trials or to distribute new methods after completion of Phase 3 trials.

The Council's International Committee for Contraception Research (ICCR) comprises distinguished scientists and clinical investigators from around the world. The group conducts clinical trials of the Population Council's candidate contraceptives. Members of the ICCR and their staff at cooperating universities and clinics help define the needs of the field, contribute ideas for new methods, establish the efficacy of the new methods, and enroll and follow up subjects in Phase 1, 2, and 3 clinical trials.

Products under development for men have included subdermal implants and a novel approach that involves temporarily perturbing the attachments between cells in the testis. Methods under development for women have included spermicides and microbicides, subdermal implants, intrauterine delivery systems, vaginal rings, and transdermal systems.

Research on existing contraceptive products
The Population Council also continues to test its already-approved products to provide data for changes in the U.S. Food and Drug Administration (FDA)–sanctioned labeling. For example, the Council and the World Health Organization continued clinical trials on the Copper T 380A intrauterine device (IUD) to prove the method's efficacy up to 10 years. (This IUD was approved for 8–10 years of use in 1994.) Similarly, studies have demonstrated that Norplant^® implants can be used safely and effectively through seven years (instead of five) and that Jadelle^® implants can be used through five years (instead of three). The new data were provided to regulatory authorities so that changes in the labeling could be authorized. In 2002 the FDA approved Jadelle for five years of use. 

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See Also

• Contraceptives on the Market

• Product Research and Development

• Contraceptives
  • Female

  • Male

• Hormone Therapy
  • Female

  • Male

• Microbicides (Carraguard^® )

• Population Council's International Committee for Contraception Research

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This page updated 12 October 2006

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