Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation January 2003

GUIDANCE DOCUMENT

• Issued by: Center for Drug Evaluation and Research

This guidance updates the final guidance Guidance for Clinical Evaluation of Combination Estrogen/Progestin - Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women, published in March 1995. The guidance is intended to provide recommendations to industry for studies of estrogen and estrogen/progestin drug products for the treatment of moderate to severe vasomotor symptoms associated with the menopause and moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. The guidance also addresses the reduction of the risk of endometrial hyperplasia or adenocarcinoma from estrogen exposure in postmenopausal women who have a uterus. For other indications, such as prevention of osteoporosis, sponsors are asked to direct inquiries to the appropriate CDER Office of New Drugs review division.

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