Hormonal Drug Effectiveness, Safety Guidance

FDA has issued a draft guidance, Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy, with recommendations for clinical trials designed to establish clinical effectiveness and safety for hormonal drug products intended to prevent pregnancy. The document says that drug product development in hormonal contraception has evolved over the years, especially with development of lower-dose hormonal drug products and longer-acting reversible contraceptives. “Changes in patient demographics, pregnancy testing, determinations of conception date, and dosing directions have also occurred,” it says. The guidance reflects those developments and is generally consistent with advice the agency has been providing to individual sponsors developing hormonal drug products, FDA says.

Clinical trial design features covered in the draft are recommended enrollment criteria, study elements, efficacy considerations, and safety considerations.