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NCT03294538 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 663
- Enrollment target
NCT03294538: Completed Phase 3 study, sponsored by Actavis.
NCT03294538 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 663 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03294538, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 663 participants
- Enrollment target
Study Summary
The objectives of this study were to evaluate the therapeutic equivalence of the Test formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva Pharmaceuticals, United States of America) to the marketed product, Estrace® Cream estradiol vaginal cream USP, 0.01% (Warner Chilcott) in participants with atrophic vaginitis; to demonstrate the superiority of the Test and Reference (active) treatments over Placebo (vehicle) cream in participants with atrophic vaginitis; and to compare the safety of Test, Reference, and Placebo treatments in participants with atrophic vaginitis.
Primary Outcome
Treatment comparison of the number of participants in the PP population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy w
Interventions
- DRUG Generic Estradiol Vaginal Cream USP, 0.01%
- DRUG Estrace® Vaginal Cream USP, 0.01%
- DRUG Vehicle Vaginal Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 663 participants |
| Start Date | 2016-05-18 |
| Est. Completion | 2017-02-15 |
| Phase | Phase 3 |
What the finished NCT03294538 record still lists
NCT03294538 is an interventional study that assigns participants to a tested intervention. The registered 663 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 3 interventions - of which Generic Estradiol Vaginal Cream USP, 0.01% is the first listed.
NCT03294538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03294538 about?
NCT03294538 is a clinical study titled "Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis". The objectives of this study were to evaluate the therapeutic equivalence of the Test formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva Pharmaceuticals, United States of America) to the marketed product, Estrace® Cream estradiol vaginal cream USP, 0.01% (War...
What is the current status of trial NCT03294538?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 663 participants. The study started on 2016-05-18. Estimated completion is 2017-02-15.
What interventions are being tested in trial NCT03294538?
The interventions under investigation include: Generic Estradiol Vaginal Cream USP, 0.01% (DRUG), Estrace® Vaginal Cream USP, 0.01% (DRUG), Vehicle Vaginal Cream (DRUG).
Who is sponsoring clinical trial NCT03294538?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03294538's enrollment target sits among peer trials
663 553rd of 2000 higher than 1,447 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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