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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.
Details
| Lead sponsor | Shionogi |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 826 |
| Start date | 2006-01 |
| Completion | 2007-12 |
Conditions
- Atrophy
- Vaginal Diseases
Interventions
- Ospemifene 30 mg
- Ospemifene 60 mg
- Placebo
- Nonhormonal vaginal lubricant
Primary outcomes
- Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness — Baseline (Randomization) to Week 12
This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe - Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity — Baseline (Randomization) to Week 12
This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe - Mean Change From Baseline in Vaginal pH — Baseline (Screening) to Week 12
- Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear — Baseline (Screening) to Week 12
- Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear — Baseline (Screening) to Week 12