At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 631 enrolled
Drug / intervention
Ospemifene +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.
A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients With Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) Due to Menopause
In Brief
A Phase 3 clinical trial evaluating Ospemifene and Placebo for Vaginal Dryness. Completed, enrolled 631 participants.
Detailed Summary
The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaginal Dryness
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartJan 2016
Primary CompletionJun 2017
Study CompletionJul 2017
TodayJul 2026
First PostedDec 23, 2015
Enrollment StartJan 26, 2016
Primary CompletionJun 23, 2017
Study CompletionJul 5, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.5 years ago
Interventions
Ospemifenedrug
60 mg tablet
Placebodrug
Tablet identical to the ospemifene tablet without drug