Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
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.
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
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 protocol, eligibility criteria, and contact information for NCT02253173 live on ClinicalTrials.gov.