On July 11, the U.S. Food and Drug Administration (FDA) issued new draft guidance entitled “Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy”. This guidance document provides recommendations for researchers and developers conducting clinical trials to ensure the safety and effectiveness of contraceptives. Suggestions include commentary on optimal trial design, metrics of success, definitions of pregnancy, and subject activities such as frequent pregnancy tests and diary recording of menses. Notably, the guide emphasizes the importance of including obese women and women of all menopausal groups in such trials due to recent expansion of contraceptive usage to different demographics. It also reflects other developments in hormonal contraception over the years, including lower-dose and longer-acting methods and changes in pregnancy testing, determinations of conception date, and dosing directions.
The FDA is calling for comments on this draft guidance, which is expected to align with and consolidate advice the FDA is currently giving to individual companies developing hormonal contraception. Comments must be submitted here by September 10, 2019.