Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent

Pregnancy Guidance for Industry

This draft guidance document is being distributed for comment purposes only.

This guidance provides recommendations for clinical trials designed to establish clinical effectiveness and safety for hormonal drug products intended to prevent pregnancy. Drug product development in hormonal contraception has evolved over the years, especially with the 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. This guidance reflects these developments and is generally consistent with advice we have been providing to individual sponsors developing hormonal drug products.

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