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Completed Phase 3 Interventional Accepts healthy volunteers Results available

A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis

ClinicalTrials.gov ID: NCT02195986

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.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 7:55 AM EDT

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

Study identification

NCT ID
NCT02195986
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Mylan Pharmaceuticals Inc
Industry
Enrollment
366 participants

Conditions and interventions

Interventions

  • Estradiol Vaginal Cream, 0.01% Drug
  • Estrace® 0.01% cream Drug
  • Placebo Vaginal Cream Drug

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
May 31, 2014
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014
Last update posted
Mar 8, 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 8, 2022 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02195986 live on ClinicalTrials.gov.

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