At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 535 enrolled
Drug / intervention
Estradiol +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.
Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Alvogen Pine Brook LLC.) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis
In Brief
A Phase 3 clinical trial evaluating Estradiol, Placebos, and 1 other intervention for Atrophic Vaginitis. Completed, enrolled 535 participants.
Detailed Summary
The purpose of this study is to determine the therapeutic equivalence of Alvogen's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrophic Vaginitis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMar 2016
Primary CompletionDec 2016
First PostedDec 2016
TodayJul 2026
First PostedDec 16, 2016
Enrollment StartMar 1, 2016
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.5 years ago
Interventions
Estradioldrug
Estradiol Vaginal Cream
Placebosdrug
Placebo with no active pharmaceutical ingredients. Topical vaginal cream
Referencedrug
Estrace Vaginal Cream