At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 309 enrolled
Drug / intervention
estradiol, 10 mcgdrug
Likely dose
estradiol, 10 mcgfrom 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 12 Month Double-blind, Randomized, Parallel-group, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet) for the Treatment of Postmenopausal Atrophic Vaginitis Symptoms
In Brief
A Phase 3 clinical trial evaluating estradiol, 10 mcg for Menopause and Postmenopausal Vaginal Atrophy. Completed, enrolled 309 participants across 57 sites in 2 countries.
Detailed Summary
This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause, Postmenopausal Vaginal Atrophy
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2005
First PostedApr 2005
Primary CompletionMay 2007
TodayJul 2026
First PostedApr 20, 2005
Enrollment StartMar 1, 2005
Primary CompletionMay 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 21.2 years ago
Interventions
estradiol, 10 mcgdrug