? Copper Vaginal Contraception Unintended pregnancy rates in the U.S., as well as in many countries around the world, remain unacceptably high. Many women are reluctant to use hormonal contraceptives due to concerns about thromboembolism, irregular vaginal bleeding, or other side effects. Existing hormone-free contraceptive options that are reversible include barrier methods which typically have relatively high failure rates, and copper intrauterine contraceptives ? which require placement by a trained clinician and often increase menstrual bleeding and cramping. Thus, new contraceptive options are needed. A woman-controlled contraceptive that is more effective than existing barrier contraceptives and could be initiated without a clinician's assistance would be of great benefit in many settings; especially if a single contraceptive device could be used for an extended period of time and could simultaneously reduce risks of sexually transmitted infection as a multi-purpose prevention technology. The proposed research project will develop a copper intravaginal contraceptive product that may also reduce risk for acquisition of sexually transmitted infections. In-vitro experiments in the R61 phase of the work will guide product development in an iterative process. The safety and effectiveness testing planned for the R33 phase will employ a non-human primate model that is well-established for contraceptive development. Sub- aims will serve as targets, and product fabrication and contraceptive effectiveness will be the primary milestones of the R61 and R33 phases, respectively. Over the 5-year project, we will hone prototypes for long- and short-acting versions of an exciting and innovative female-controlled, non-hormonal copper vaginal contraceptive method that will be suitable for Phase I human clinical testing.
? Copper Vaginal Contraception The proposed research project will develop novel intravaginal formulations of copper contraceptives that may also reduce risk for acquisition of sexually transmitted infections. Extensive laboratory testing will guide development of prototype copper-containing rings and films and the best ones will be chosen for further testing in animals. This project has high probability to bring an exciting and innovative female-controlled, non- hormonal copper vaginal contraceptive method from idea to the brink of clinical testing in just five years.
