A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
Public ClinicalTrials.gov record NCT02195986. 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
Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Mylan) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.
Study identification
- NCT ID
- NCT02195986
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 366 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 40 Years to 70 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2014 (Type not available)
- Primary completion
- Dec 2014 (Actual)
- Completion
- Dec 2014 (Actual)
- Last update posted
- Mar 9, 2022
2014
United States locations
- U.S. sites
- 21
- U.S. states
- 6
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ARA-Arizona Research Associates | Tucson | Arizona | 85712 | — |
| Axis Clinical Trials | Los Angeles | California | 90036 | — |
| Northern CA Research | Sacramento | California | 95821 | — |
| MCCR | San Diego | California | 92108 | — |
| Women's Health Care Research Corp. | San Diego | California | 92123 | — |
| MCB Clinical Research Centers | Colorado Springs | Colorado | 80910 | — |
| Downtown Women's Health Care | Denver | Colorado | 80209 | — |
| Horizons Clinical Research Center, LLC | Denver | Colorado | 80220 | — |
| Sunrise Medical Research | Coral Springs | Florida | 33065 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| Meridien Research | Lakeland | Florida | 33805 | — |
| OB-GYN Associates of Mid Florida | Leesburg | Florida | 34748 | — |
| SouthCoast Research Center | Miami | Florida | 33136 | — |
| Veritas Research, Corp. | Miami Lakes | Florida | 33014 | — |
| Physician Care Clinical Research LLC | Sarasota | Florida | 34239 | — |
| Meridien Research | St. Petersburg | Florida | 33709 | — |
| Sunrise Medical Research | Tamarac | Florida | 33351 | — |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | — |
| Georgia Center for Women | Atlanta | Georgia | 30312 | — |
| Lawrence OB/GYN Clinical Research, LLC | Lawrenceville | New Jersey | 08690 | — |
| Women's Health Research Center/The Center for Women's Health & Wellness, LLC | Plainsboro | New Jersey | 08536 | — |
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 NCT02195986, 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 Mar 9, 2022 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02195986 live on ClinicalTrials.gov.