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Completed Phase 3 Interventional Results available

Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women

ClinicalTrials.gov ID: NCT02253173

Public ClinicalTrials.gov record NCT02253173. 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 21, 2026, 6:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Efficacy of TX-004HR in Postmenopausal Women With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy

Study identification

NCT ID
NCT02253173
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
TherapeuticsMD
Industry
Enrollment
764 participants

Conditions and interventions

Interventions

  • Estradiol Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
40 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
Aug 31, 2014
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015
Last update posted
May 24, 2017

2014 – 2015

United States locations

U.S. sites
100
U.S. states
32
U.S. cities
88
Facility City State ZIP Site status
Medical Affiliated Research Center Huntsville Alabama 35801
Montogomery Women's Health Montgomery Alabama 36117
Cactus Clinical Research Mesa Arizona 85209
Arizona Wellness Center for Women Phoenix Arizona 85032
Radiant Research Scottsdale Arizona 85251
Visions Clinical Research - Tucson Tucson Arizona 85712
Sutter East Bay Medical Foundation Berkeley California 94705
Torrance Clinical Research Institute Inc Lomita California 90717
Futura Research Norwalk California 90650
Northern California Research Sacramento California 95821
Medical Center for Clinical Research San Diego California 92108
San Diego Sexual Medicine San Diego California 92120
Women's Health Care Research Corp. San Diego California 92123
Lynn Institute of the Rockies Colorado Springs Colorado 80909
Downtown Women's Health Care Denver Colorado 80209
Horizons Clinical Research Center Denver Colorado 80220
Red Rocks OB/Gyn Lakewood Colorado 80228
Clinical Research Consulting Milford Connecticut 06460
Coastal Connecticut Research, LLC New London Connecticut 06320
James A. Simon, Women's Health & Research Consultants Washington D.C. District of Columbia 20036
South Florida Medical Research Aventura Florida 33180
Nature Coast Clinical Research Crystal River Florida 34429
Avail Clinical Research DeLand Florida 32720
Clinical Physiology Associates Fort Myers Florida 33916
UF Health Physicians Women's & REI Springhill Gainesville Florida 32606
UF College of Medicine-Jacksonville, Dept. of Obstetrics and Gynecology Jacksonville Florida 32207
Jacksonville Center for Clinical Research Jacksonville Florida 32216
South Florida Wellness & Clinical Research Institute Margate Florida 33063
New Age Medical Research Corporation Miami Florida 33186
Suncoast Clinical Research, Inc. New Port Richey Florida 34652
Healthcare Clinical Data North Miami Florida 33161
Ideal Clinical Research North Miami Beach Florida 33162
Radiant Research Pinellas Park Florida 33781
All Women's Healthcare of West Broward Plantation Florida 33324
Physician Care Clinical Research Sarasota Florida 34239
Comprehensive Clinical Trials West Palm Beach Florida 33409
Women's Health Associates Atlanta Georgia 30342
Masters of Clinical Research, Inc. Augusta Georgia 30909
Soapstone Center for Clinical Research Decatur Georgia 30034
WR-Mount Vernon Clinical Research Sandy Springs Georgia 30328
Fellows Research Alliance, Inc. Savannah Georgia 31046
Advanced Clinical Research Boise Idaho 83642
Women's Healthcare Associates P.A. Idaho Falls Idaho 83404
Radiant Research Chicago Illinois 60654
American Health Network of Indiana, LLC Avon Indiana 46123
Lafayette Clinical Research Group Lafayette Indiana 47905
Cypress Medical Research Center Wichita Kansas 67226
Central Kentucky Research Associates, Inc. Lexington Kentucky 40509
Bluegrass Clinical Research, Inc. Louisville Kentucky 40291
Horizon Research Group of Opelousas Eunice Louisiana 70535
Capital Women's Care Frederick Maryland 21702
Maryland Center for Sexual Health Lutherville Maryland 21093
ClinSite, LLC Ann Arbor Michigan 48106
Beyer Research Kalamazoo Michigan 49009
Saginaw Valley Medical Research Group, L.L.C. Saginaw Michigan 48604
Montana Health Billings Montana 59102
Women's Clinic of Lincoln Lincoln Nebraska 68510
Office of Edmond E. Pack, MD Las Vegas Nevada 89113
Office of R. Garn Mabey, MD Las Vegas Nevada 89128
Lawrence OB-GYN Clinical Research, LLC Lawrenceville New Jersey 08648
Rutgers-Robert Wood Johnson Medical School New Brunswick New Jersey 08901
Women's Health Research Center Plainsboro New Jersey 08536
Bosque Women's Care Albuquerque New Mexico 87109
Southwest Clinical Research Albuquerque New Mexico 87109
Columbia University Medical Center New York New York 10032
Suffolk OB/GYN Port Jefferson New York 08536
Women's Wellness Clinic Durham North Carolina 27713
Pinewest OB-GYN, Inc. High Point North Carolina 27262
Wake Research Associates Raleigh North Carolina 27612
Hawthorne Research Winston-Salem North Carolina 27103
Lyndhurst Clinical Research Winston-Salem North Carolina 27103
Lillestol Research Fargo North Dakota 58103
Radiant Research Akron Ohio 44311
University of Cincinnati Physicians Company Cincinnati Ohio 45267-0457
Rapid Medical Research Cleveland Ohio 44122
Columbus Center for Women's Health Research Columbus Ohio 43213
HWC Women's Research Center Englewood Ohio 45322
Landerbrook Health Center Mayfield Heights Ohio 44124
Sunstone Medical Research Medford Oregon 97504
The Clinical Trial Center Jenkintown Pennsylvania 19046
Clinical Research of Philadelphia Philadelphia Pennsylvania 19114
Clinical Trials Research Services Pittsburgh Pennsylvania 15206
Fellows Research Alliance, Inc. Bluffton South Carolina 29910
Vista Clinical Research Columbia South Carolina 29201
Coastal Carolina Research Center Mt. Pleasant South Carolina 29464
Chattanooga Medical Research Chattanooga Tennessee 37404
Advanced Research Associates Corpus Christi Texas 78414
Research Across America Dallas Texas 75234
UT Southwestern Medical Center Dallas Texas 75390-9032
Advances in Health Houston Texas 77030
Hwca, Pllc Houston Texas 77054
TMC Life Research Houston Texas 77054
Stone Oak, LLC dba Discovery Clinical Trials San Antonio Texas 78258
National Clinical Research-Norfolk Norfolk Virginia 23502
Clinical Research Center, EVMS Norfolk Virginia 23507
Virginia Women's Center, Inc. Richmond Virginia 23233
National Clinical Research-Richmond, Inc Richmond Virginia 23294
Tidewater Clinical Research Virginia Beach Virginia 23456
Seattle Women's Health, Research, and Gynecology Seattle Washington 98105
North Spokane Women's Health Spokane Washington 99207

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02253173, 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 24, 2017 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02253173 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →