ACQUISITION OF THE NESTORONE ESTRADIOL (NES/E2) VAGINAL RING AS CONTRACEPTIVE

The 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 provide qualified sites the ability to perform clinical trials of new products, including a Statistical and Clinical Coordinating Center (SCCC).

The purpose of this contract is to conduct work required and to provide the appropriate deliverables associated with the development toward a clinical prototype of the Nestorone/Estradiol (Nes/E2) vaginal rings. This work will be conducted by NICHD in collaboration with the Population Council (PC). PC holds the Investigational New Drug (IND) application with FDA for the rings.

In the first phase of the ring development, the Government was supposed received a detailed analysis regarding the feasibility of manufacturing the vaginal rings. However, due to unforeseen circumstances, a report could not be delivered. Consequently, PC has initiated a search for a new vendor to provide this analysis, which will contain a thorough plan describing the cost and timeline of the work related to the optimization and Good Manufacturing Practice (GMP) manufacturing of the vaginal rings. These activities will be incorporated in this task order.