PROTOCOL FINALIZATION, PROCUREMENT OF REGULATORY APPROVAL, AND COMPLETE START-UP ACTIVITIES FOR THE OVAPRENE VAGINAL DEVICE CLINICAL TRIAL

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has a mission to develop safe and effective contraceptives for women and for men. The Contraceptive Clinical Trials Network (CCTN) was established to perform clinical trials of new products. Health Decisions (HD) serves as the coordinator of these clinical trials at sites that have been pre-qualified to conduct a variety of clinical trials. HD provides coordination of protocol development, clinical trial initiation, coordination, monitoring, and data analysis for products that are currently in the Contraception Development Program (CDP of the NICHD Division of Population Health Research [DiPHR]) developmental pipeline. Development of additional non-hormonal contraceptive options is a high priority product area within the pipeline. The services needed for the activities described herein require clinical evaluation of the Ovaprene® device, which is a hormone-free contraceptive device intended for single-cycle use by women of child-bearing age. NICHD is partnering with Ovaprene manufacturer, Daré, to sponsor a 13-month contraceptive efficacy study in approximately 800 women who complete 13 cycles of use. The objective of this contract is to finalize the protocol design, procure regulatory approval, complete start-up activities, site initiation, and initiation of coordination of recruitment and enrollment activities.