Clinical investigation of steroid contraceptives in women - Scientific guideline

This document addresses the clinical-pharmacological studies of contraceptives intended for use by women, containing substances with sex steroid action as active substance(s). It also concerns safety and efficacy aspects of these medicinal products.

Keywords: Steroid contraceptives

Current effective version

Guideline on clinical investigation of steroid contraceptives in women

Adopted Reference Number: EMEA/CPMP/EWP/519/98 Rev 1 Legal effective date: 01/01/2006