A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Naturally or surgically menopausal

• 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