Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy
Public ClinicalTrials.gov record NCT03332303. 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
Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi-Site Study to Evaluate Therapeutic Equivalence of Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC) to Estrace® Cream (Warner Chilcott) in Treatment of Vulvar and Vaginal Atrophy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objectives of this study are to evaluate the therapeutic equivalence of the Test formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients with vulvar and vaginal atrophy, and compare the safety of Test, Reference and Placebo treatments in patients with vulvar and vaginal atrophy.
Study identification
- NCT ID
- NCT03332303
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 540 participants
Conditions and interventions
Conditions
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
- Oct 26, 2017 (Actual)
- Primary completion
- Mar 15, 2018 (Actual)
- Completion
- Mar 15, 2018 (Actual)
- Last update posted
- May 30, 2024
2017 – 2018
United States locations
- U.S. sites
- 27
- U.S. states
- 13
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Douglas Young, MD | Sacramento | California | 95821 | — |
| Medical Center for Clinical Research | San Diego | California | 92108 | — |
| Women's Health Care Research Corp. | San Diego | California | 92111 | — |
| Downtown Women's Health Care | Denver | Colorado | 80209 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| New Age Medical Research Corporation | Miami | Florida | 33186 | — |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | — |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | — |
| Ormond Medical Arts Pharmaceutical Research Center | Ormond Beach | Florida | 32174 | — |
| Health Awareness, Inc. | Port Saint Lucie | Florida | 34952 | — |
| Physician Care Clinical Research, LLC | Sarasota | Florida | 34239 | — |
| Well Pharma Medical Research Group | South Miami | Florida | 33143 | — |
| Meridien Research, Inc. | St. Petersburg | Florida | 33709 | — |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | — |
| Cypress Medical Research Center, LLC | Wichita | Kansas | 67226 | — |
| Praetorian Pharmaceutical | Marrero | Louisiana | 70072 | — |
| Southern Clinical Research Associates | Metairie | Louisiana | 70001 | — |
| Canton Obstetrics and Gynecology | Canton | Michigan | 48187 | — |
| Beyer Research | Kalamazoo | Michigan | 49009 | — |
| Women's Clinic of Lincoln | Lincoln | Nebraska | 68510 | — |
| Lawrence Ob-Gyn Clinical Research, LLC | Lawrenceville | New Jersey | 08648 | — |
| Aventiv Research, Inc. | Columbus | Ohio | 43213 | — |
| Novum PRS | Pittsburgh | Pennsylvania | 15219 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| Vernon & Waldrep OBGYN Associates | Dallas | Texas | 75230 | — |
| Women's Clinical Research Center dba Seattle Women's Health, Research, Gynecology | 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 NCT03332303, 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 May 30, 2024 · 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 NCT03332303 live on ClinicalTrials.gov.