A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women

Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 and 60 Mg Daily Doses With Placebo

The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.

Inclusion Criteria:

• Naturally or surgically postmenopausal
• Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse)
• Vaginal pH greater than 5.0
• 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

• Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology
• Abnormal Pap smear
• Uterine bleeding of unknown origin or uterine polyps
• Current vaginal infection requiring medication