Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus

• Status: Completed
• Trial end date: 2008-09-18
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.

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

Details

• Lead Sponsor: Shionogi
• Collaborator: QuatRx Pharmaceuticals
• Treatments: Tamoxifen

Criteria

Inclusion Criteria:

• Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and self-reported symptoms at Baseline for Protocol 15-50310

• Had an intact uterus

• Met the inclusion and exclusion criteria for Protocol 15-50310

• Had completed Protocol 15-50310

Exclusion Criteria:

• Had clinically significant abnormal findings at the Week 12 End of Study visit for Protocol 15-50310

• Had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subject's ability to comply with the study procedures