At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 180 enrolled
Drug / intervention
Ospemifene (Dose 1) +2 moredrug
Likely dose
Not stated in 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.
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: A 40 Week Randomized, Double Blind, Placebo Controlled, Follow-Up to Protocol 15-50310.
In Brief
A Phase 3 clinical trial evaluating Ospemifene (Dose 1), Ospemifene (Dose 2), and 1 other intervention for Atrophy and Vaginal Diseases. Completed, enrolled 180 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrophy, Vaginal Diseases
Countries--
CollaboratorsQuatRx Pharmaceuticals
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
Primary CompletionAug 2008
Study CompletionSep 2008
First PostedApr 2012
TodayJul 2026
First PostedApr 26, 2012
Enrollment StartMay 16, 2006
Primary CompletionAug 19, 2008
Study CompletionSep 18, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.2 years ago
Interventions
Ospemifene (Dose 1)drug
Ospemifene (Dose 2)drug
Placebodrug