A Clinical Study to Evaluate the Safety of Ospemifene

Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 MG Oral Daily Dose of Ospemifene With Placebo

The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.

Inclusion Criteria:

• Naturally or surgically menopausal
• Intact uterus
• Vaginal pH greater than 5.0
• 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

• Evidence of endometrial hyperplasia, cancer or other pathology
• Abnormal Pap smear
• Uterine bleeding of unknown origin or uterine polyps
• Current vaginal infection requiring medication
• Use of hormonal medications
• Clinically significant abnormal gynecological findings other than signs of vaginal atrophy