A Clinical Study to Evaluate the Safety of Ospemifene

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

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

Criteria

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