Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
Public ClinicalTrials.gov record NCT03294538. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Estradiol Vaginal Cream USP, 0.01% (Teva Pharmaceuticals, USA) to Estrace® Estradiol Vaginal Cream, USP, 0.01% (Warner Chilcott) in the Treatment of Atrophic Vaginitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03294538
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 663 participants
Conditions and interventions
Conditions
Interventions
- Generic Estradiol Vaginal Cream USP, 0.01% Drug
- Estrace® Vaginal Cream USP, 0.01% Drug
- Vehicle Vaginal Cream Drug
Drug
Eligibility (public fields only)
- Age range
- 30 Years to 75 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 18, 2016 (Actual)
- Primary completion
- Feb 15, 2017 (Actual)
- Completion
- Feb 15, 2017 (Actual)
- Last update posted
- Dec 26, 2019
2016 – 2017
United States locations
- U.S. sites
- 44
- U.S. states
- 16
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site Number 44 | Tucson | Arizona | 85710 | — |
| Site Number 17 | Tucson | Arizona | 85712 | — |
| Site Number 31 | La Mesa | California | 91942 | — |
| Site Number 11 | Sacramento | California | 95821 | — |
| Site Number 05 | San Diego | California | 91208 | — |
| Site Number 15 | San Diego | California | 92111 | — |
| Site Number 25 | Colorado Springs | Colorado | 80923 | — |
| Site Number 01 | Denver | Colorado | 80209 | — |
| Site Number 14 | Denver | Colorado | 80220 | — |
| Site Number 18 | New London | Connecticut | 06320 | — |
| Site Number 06 | Jupiter | Florida | 33458 | — |
| Site Number 13 | Lake Worth | Florida | 33461 | — |
| Site Number 27 | Miami | Florida | 33015 | — |
| Site Number 40 | Miami | Florida | 33130 | — |
| Site Number 20 | Miami | Florida | 33136 | — |
| Site Number 39 | Miami | Florida | 33144 | — |
| Site Number 38 | Miami | Florida | 33186 | — |
| Site Number 30 | Miami Lakes | Florida | 33014 | — |
| Site Number 08 | New Port Richey | Florida | 34652 | — |
| Site Number 03 | Ormond Beach | Florida | 32174 | — |
| Site Number 45 | Port Saint Lucie | Florida | 34952 | — |
| Site Number 10 | Sarasota | Florida | 34239 | — |
| Site Number 19 | St. Petersburg | Florida | 33709 | — |
| Site Number 02 | West Palm Beach | Florida | 33409 | — |
| Site Number 29 | Roswell | Georgia | 30075 | — |
| Site Number 22 | Savannah | Georgia | 31406 | — |
| Site Number 21 | Wichita | Kansas | 67226 | — |
| Site Number 33 | Metairie | Louisiana | 70001 | — |
| Site Number 16 | Kalamazoo | Michigan | 49009 | — |
| Site Number 34 | Saginaw | Michigan | 48604 | — |
| Site Number 35 | Lincoln | Nebraska | 68510 | — |
| Site Number 12 | Lawrenceville | New Jersey | 08648 | — |
| Site Number 26 | Plainsboro | New Jersey | 08536 | — |
| Site Number 36 | Raleigh | North Carolina | 27607 | — |
| Site Number 04 | Winston-Salem | North Carolina | 27103 | — |
| Site Number 37 | Winston-Salem | North Carolina | 27103 | — |
| Site Number 07 | Columbus | Ohio | 43213 | — |
| Site Number 24 | Englewood | Ohio | 45322 | — |
| Site Number 28 | West Chester | Ohio | 45069 | — |
| Site Number 23 | Bluffton | South Carolina | 29910 | — |
| Site Number 41 | Mt. Pleasant | South Carolina | 29464 | — |
| Site Number 43 | Myrtle Beach | South Carolina | 29572 | — |
| Site Number 32 | Dallas | Texas | 75230 | — |
| Site Number 09 | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03294538, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 26, 2019 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03294538 live on ClinicalTrials.gov.