CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 695 enrolled
Drug / intervention
estrace cream (Perrigo) +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.

Search/NCT02770365
NCT02770365Phase 3Completed
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Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy

Padagis LLC·interventional·Posted May 12, 2016·Updated Nov 2, 2021

In Brief

A Phase 3 clinical trial evaluating estrace cream (Perrigo), estrace cream (Reference), and 1 other intervention for Atrophy. Completed, enrolled 695 participants across 1 site.

Detailed Summary

To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrophy
CountriesUnited States
CollaboratorsImpax Laboratories, LLC

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 12, 2016
Enrollment StartMay 1, 2016
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.1 years ago

Interventions

estrace cream (Perrigo)drug

estrace cream (Reference)drug

Placebo creamdrug