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Gynuity Receives Grant to Plan Development of “On-Demand” Oral Contraceptive

Gynuity Health Projects has been awarded a grant by the Bill & Melinda Gates Foundation to prepare a plan for the development of the first in what would be an entirely new class of modern contraceptive methods: a pericoital or “on-demand” oral contraceptive. Whereas currently available oral contraceptives must be taken every day, on-demand oral contraceptives would be taken only when a woman has sex. This regimen would substantially reduce dosing frequency and enhance convenience and privacy. Importantly, the pericoital pills will be designed to be effective if ingested either before or after sex, eliminating the need for advance planning, a substantial barrier to use of other coital-related contraceptives. This on-demand method is expected to appeal particularly to women who have infrequent sex, a group that tends to underutilize existing contraceptive options.

The new product is likely to contain the hormone levonorgestrel, a component of many widely used contraceptive methods since the 1960s. Fifteen studies involving more than 8,400 women conducted several decades ago suggested that pericoital oral contraceptives containing this hormone may be very safe, reasonably effective, and well accepted by women. However, because those older studies do not meet current standards, new research will be needed before this method can be approved for commercial sale.

Gynuity will collaborate on this planning project with partner organizations including PATH, based in Seattle, WA, and Concept Foundation, based in Bangkok, Thailand. The project will include several components:

  • preparation of a regulatory strategy to obtain approval to market the method in both developed and developing countries;
  • identification of manufacturers to produce the pills;
  • design of the clinical research to evaluate the product’s safety and efficacy, including preparation of clinical trial documents and selection of approximately 20 sites;
  • research to assess potential demand for the new method among women in several developing countries; and
  • a plan for introduction of the method in target countries in Sub-Saharan Africa and South Asia.

The project will be guided by a Technical Advisory Group comprised of experts in contraceptive R&D, regulation, women’s health advocacy, and policy and marketing. Once the planning project is complete, a decision will be made regarding the feasibility of seeking funding to develop the new product.

This project capitalizes on Gynuity’s expertise in reproductive health research and advocacy and its commitment to ensuring that high-quality, low-cost reproductive health technologies are available to underserved populations worldwide.

For more information about this initiative, write to: