United States regulatory considerations for intrauterine progestins for hormone replacement therapy.

This paper presents information about U.S. Food and Drug Administration (FDA) considerations for intrauterine progestins as part of a hormone replacement therapy strategy. Current U.S.-approved intrauterine systems are reviewed as well as FDA formal guidance to industry regarding clinical evaluation of combination hormone products. The formal guidance is contrasted with FDA actions for approved combination products, and recommendations for proceeding with a development plan for an intrauterine delivery approach are discussed.