FDA Issues Guidance on Effectiveness and Safety for Hormonal Pregnancy Prevention Drugs

The FDA issued a draft guidance on trials of hormonal birth control products that makes recommendations regarding enrollment criteria, study elements, and safety and efficacy considerations.

According to the guidance, sponsors should sign up nonpregnant, premenopausal women who have no history of infertility, are sexually active, have regular menstrual cycles and show no evidence of dysplasia or invasive cervical cancer upon screening.

Single-arm, open-label, historically controlled trials of at least one year in length are usually adequate for establishing efficacy, the agency says.