Key Operational And Design Considerations In Contraceptive Development

Women and their OB/GYNs can select from an enormous variety of contraceptive products today. This includes multiple categories of contraceptives – oral contraceptives, implants, intrauterine devices (IUDs) or systems (IUSs), injectables, patches, rings, diaphragms and spermicides. Within categories there is usually a choice of multiple products. With contraceptives already available in such variety, it would be easy to assume that opportunities in new contraceptive development are limited. However, many women and OB/GYNs see room for improvement of contraceptives in areas including comfort, convenience, reduction in side effects, methods of device insertion, ease of reversibility and the overall balance of risk vs. benefit.

Early contraceptive development often progresses through testing of multiple prototypes for devices or doses and formulations for hormonal contraceptives. After selection of the best candidate for phase 3 studies to support marketing submissions, contraceptive developers need to be aware of several design and operational considerations.