USA – Hormonal Contraception: FDA Drafts Guidance on Clinical Trial Recommendations

As hormonal drugs to prevent pregnancy have evolved over the years, the US Food and Drug Administration (FDA) on Thursday drafted new guidance for drug developers on the recommendations for clinical trials designed to establish clinical effectiveness and safety for such products.

In terms of key considerations for clinical trial design features, the six-page draft begins by explaining the recommended enrollment criteria for nonpregnant, premenopausal woman in trials, which includes having regular menstrual cycles of between 21 and 35 days and engaging in vaginal intercourse at least once per month with a partner “who is not known to be subfertile or infertile,” among other criteria.

The draft also explains how although some contraceptives may not be as effective for women with increased body weight, “Sponsors should not place restrictions on body mass index (BMI) for trial enrollment. The trial population should include obese women (i.e., defined as BMI of at least 30 kg/m2), and the analysis plan should include a prespecified subgroup efficacy analysis in this population.”…