At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 336 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, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms
In Brief
A Phase 3 clinical trial evaluating estradiol, 10 mcg for Menopause and Postmenopausal Vaginal Atrophy. Completed, enrolled 336 participants across 42 sites in 7 countries.
Detailed Summary
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause, Postmenopausal Vaginal Atrophy
CountriesCzechia, Denmark, Finland, France, Hungary, Norway, Sweden
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedFeb 2007
Primary CompletionNov 2008
TodayJul 2026
First PostedFeb 5, 2007
Enrollment StartJan 1, 2007
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.4 years ago
Interventions
estradiol, 10 mcgdrug
Tablets, administered intravaginally twice weekly