At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 919 enrolled
Drug / intervention
Ospemifene 60 mg +1 moredrug
Likely dose
Ospemifene 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women
In Brief
A Phase 3 clinical trial evaluating Ospemifene 60 mg and Placebo for Atrophy and Vaginal Diseases. Completed, enrolled 919 participants.
Detailed Summary
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrophy, Vaginal Diseases
Countries--
CollaboratorsHormos Medical, QuatRx Pharmaceuticals
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedAug 2008
Primary CompletionAug 2009
TodayJul 2026
First PostedAug 7, 2008
Enrollment StartJul 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.9 years ago
Interventions
Ospemifene 60 mgdrug
60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed
Placebodrug
oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed