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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 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 663 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03294538
The ClinicalTrials.gov registry entry for NCT03294538 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 663 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Generic Estradiol Vaginal Cream USP, 0.01% is the first listed.
NCT03294538 reports 0 study locations.
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.
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