CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 301 enrolled
Drug / intervention
Ospemifene 60Mg Oral Tabletdrug
Likely dose
Ospemifene 60Mg Oral Tabletfrom 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.

Search/NCT01586364
NCT01586364Phase 3Completed
CompareCT.gov

Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus: A 52-Week Open-Label Follow-Up to Protocol 15-50310

Shionogi·interventional·Posted Apr 26, 2012·Updated May 21, 2018

In Brief

A Phase 3 clinical trial evaluating Ospemifene 60Mg Oral Tablet for Atrophy and Vaginal Diseases. Completed, enrolled 301 participants.

Detailed Summary

The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrophy, Vaginal Diseases
Countries--
CollaboratorsQuatRx Pharmaceuticals

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 26, 2012
Enrollment StartMay 8, 2006
Primary CompletionNov 21, 2008
Study CompletionDec 22, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.2 years ago

Interventions

Ospemifene 60Mg Oral Tabletdrug