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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shionogi
• Collaborators: Hormos Medical; QuatRx Pharmaceuticals
• Treatments: Tamoxifen

Criteria

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