FDA In Brief: FDA issues draft guidance aiming to clarify recommendations for clinical trials for hormonal contraceptives
July 11, 2019
“Over the years, the FDA has recommended that companies study contraceptives in the most inclusive way possible to help ensure clinical trials reflect how these products are actually used and the latest science around them,” said Amy Abernethy, M.D. Ph.D., FDA’s principal deputy commissioner of food and drugs. “Today, the agency is issuing, for public comment, a new draft guidance to support innovation and scientific advances in women’s health and help ensure contraceptive products are adequately studied. For example, it recommends that clinical trial design for contraceptives should include women of all childbearing ages regardless of their weight, including those who are younger and older, and women who are obese.”
The U.S. Food and Drug Administration today issued a new draft guidance, “Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy” which, if finalized, would include recommendations regarding key design features for clinical trials planned to establish effectiveness and safety for hormonal contraceptives intended to prevent pregnancy. This draft guidance does not address development of contraceptive devices for this indication.
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. If finalized, this guidance would reflect these progressions and align with advice the FDA has been providing to individual companies developing hormonal contraceptives.
The draft guidance includes recommendations regarding enrollment criteria and study elements, including a recommendation that sponsors not place restrictions on body mass index for trial enrollment and that they include obese women in trials. The draft guidance also includes a recommendation that trials include participants from all premenopausal age groups who are likely to use contraception, including postmenarchal adolescents and women aged 35 years and older. These data are important to ensure the trial populations are more representative of women who are expected to use these products if approved.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.