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Completed Phase 3 Interventional Results available

A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms

ClinicalTrials.gov ID: NCT01942668

Public ClinicalTrials.gov record NCT01942668. 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 Oct 20, 2026, 8:42 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 Study Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms in Postmenopausal Women With an Intact Uterus

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter trial of postmenopausal subjects with an intact uterus.

Study identification

NCT ID
NCT01942668
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
TherapeuticsMD
Industry
Enrollment
1,845 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
40 Years to 65 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 5, 2013 (Actual)
Primary completion
Oct 28, 2016 (Actual)
Completion
Oct 28, 2016 (Actual)
Last update posted
May 6, 2019

2013 – 2016

United States locations

U.S. sites
119
U.S. states
36
U.S. cities
102
Facility City State ZIP Site status
Simon Williamson Clinic Birmingham Alabama 35211 —
Medical Affiliated Research Center Huntsville Alabama 35801 —
Coastal Clinical Research Mobile Alabama 36608 —
Mobile Ob-Gyn, P.C. Mobile Alabama 36608 —
Montgomery Women's Health Montgomery Alabama 36117 —
Advanced Research Associates Glendale Arizona 85308 —
Cactus Clinical Research Mesa Arizona 85209 —
Precision Trials Phoenix Arizona 85032 —
Radiant Research (Tucson) Tucson Arizona 85712 —
Visions Clinical Research Tucson Tucson Arizona 85712 —
Health Star Research, LLC Hot Springs Arkansas 71913 —
Sutter East Bay Medical Foundation Berkeley California 94705 —
Grossmont Center for Clinical Research La Mesa California 91942 —
Futura Research Norwalk California 90650 —
Medical Center for Clinical Research San Diego California 92108 —
Women's Health Care Research Corp. San Diego California 92111 —
Radiant Research, Inc. Santa Rosa California 95405 —
Diablo Clinical Research Walnut Creek California 94598 —
Downtown Women's Healthcare Denver Colorado 80209 —
Horizon's Clinical Research Center Denver Colorado 80220 —
Red Rocks OB/Gyn Lakewood Colorado 80228 —
Clinical Research Consulting Milford Connecticut 06460 —
Coastal Connecticut Research New London Connecticut 06320 —
South Florida Medical Research Aventura Florida 33180 —
Nature Coast Clinical Research Crystal River Florida 34429 —
Clinical Physiology Associates Fort Myers Florida 33916 —
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Gainesville Florida 32607 —
UF College of Medicine-Jacksonville, Dept. of Obstetrics and Gynecology Jacksonville Florida 32207 —
Suncoast Research Margate Florida 33063 —
Accelovance Melbourne Florida 32934 —
Suncoast Clinical Research, Inc New Port Richey Florida 34652 —
Segal Institute North Miami Florida 33161 —
Ideal Clinical Research North Miami Beach Florida 33162 —
Compass Research Orlando Florida 32806 —
Radiant Research (St. Petersburg) Pinellas Park Florida 33781 —
All Women's Healthcare of West Broward Discovery Clinical Research Plantation Florida 33324 —
Comprehensive Clinical Trials West Palm Beach Florida 33409 —
Radiant Research (Atlanta) Atlanta Georgia 30328 —
Women's Health Associates Atlanta Georgia 30342 —
Soapstone Center for Clinical Research Decatur Georgia 30034 —
Wake Research - Mount Vernon Clinical Research Sandy Springs Georgia 30328 —
Fellows Research Alliance Savannah Georgia 31406 —
Elite Clinical Trials Blackfoot Idaho 83221 —
Advanced Clinical Research Meridian Idaho 83642 —
Biofortis Addison Illinois 60101 —
Women's Health Practice Champaign Illinois 61820 —
Radiant Research (Chicago) Chicago Illinois 60654 —
The South Bend Clinic Granger Granger Indiana 46530 —
Davis Clinic Indianapolis Indiana 46250 —
Cypress Medical Research Center, LLC Wichita Kansas 67226 —
Central Kentucky Research Associates Lexington Kentucky 40509 —
Bluegrass Clinical Research Louisville Kentucky 40291 —
Horizon Research Group Eunice Louisiana 70535 —
Maryland Center for Sexual Health Lutherville Maryland 21093 —
Quest Research Institute Bingham Farms Michigan 48025 —
Female Pelvic Medicine & Urogynecology Grand Rapids Michigan 49503 —
Beyer Research Kalamazoo Michigan 49009 —
Saginaw Valley Medical Research Group Saginaw Michigan 48604 —
Radiant Research (St. Louis) St Louis Missouri 63141 —
Billings Clinical Research Billings Montana 59101 —
Montana Health Billings Montana 59102 —
Women's Clinic of Lincoln Lincoln Nebraska 68510 —
Affiliated Clinical Research INC Las Vegas Nevada 89113 —
Affiliated Clinical Research Las Vegas Nevada 89128 —
Lawrence OB-GYN Clinical Research Lawrenceville New Jersey 08648 —
Albuquerque Clinical Trials, Inc. Albuquerque New Mexico 87102 —
Bosque Women's Care Albuquerque New Mexico 87109 —
Southwest Clinical Research Albuquerque New Mexico 87109 —
Columbia University New York New York 10032 —
Suffolk OB/GYN Port Jefferson New York 11777 —
Upstate Clinical Research Associates Williamsville New York 14221 —
Women's Wellness Clinic Durham North Carolina 27713 —
Carolina Medical Trials High Point North Carolina 27262 —
Centre OBGYN Raleigh North Carolina 27607 —
Wake County Research Raleigh North Carolina 27612 —
Lyndhurst Clinical Research Salem North Carolina 27103 —
Carolina Medical Trials Winston-Salem North Carolina 27103 —
Hawthorne Research Winston-Salem North Carolina 27103 —
Triad Ob-Gyn Winston-Salem North Carolina 27103 —
Lillestol Research Fargo North Dakota 58103 —
Radiant Research (Akron) 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 —
Lynn Health Science Institute Oklahoma City Oklahoma 73112 —
Sunstone Medical Research Medford Oregon 97504 —
The Clinical Trial Center Jenkintown Pennsylvania 19046 —
Clinical Research of Philadelphia Philadelphia Pennsylvania 19114 —
Clinical Trials Research Services, LLC Pittsburgh Pennsylvania 15206 —
Omega Medical Research Warwick Rhode Island 02886 —
Fellows Research Group Bluffton South Carolina 29910 —
Vista Clinical Research Columbia South Carolina 29201 —
Upstate Pharmaceutical Research Greenville South Carolina 29615 —
Coastal Carolina Research Center Mt. Pleasant South Carolina 29464 —
Chattanooga Medical Research Chattanooga Tennessee 37404 —
Volunteer Research Group/NOCCR Knoxville Tennessee 37920 —
DiscoveResearch, Inc. Bryan Texas 77802 —
Advanced Research Associates Corpus Christi Texas 78414 —
Research Across America Dallas Texas 75234 —
Brownstone Clinical Trials Fort Worth Texas 76104 —
Advances in Health Houston Texas 77030 —
The Women's Hospital of Texas Houston Texas 77054 —
TMC Life Research Houston Texas 77054 —
Protenium Clinical Research Hurst Texas 76054 —
MacArthur OB/GYN Irving Texas 75062 —
Clinical Trials of Texas San Antonio Texas 78229 —
Stone Oak, LLC dba Discovery Clinical Trials San Antonio Texas 78258 —
NECRSA Schertz Texas 78154 —
PRO/ Salt Lake Women's Center Draper Utah 84020 —
Wasatch Clinical Research, LLC Salt Lake City Utah 84107 —
Jean Brown Research Salt Lake City Utah 84124 —
UVA/Midlife Health at North Ridge Charlottesville Virginia 22908 —
Clinical Research Center Eastern Virginia Medical School Norfolk Virginia 23507 —
Virginia Women's Center Richmond Virginia 23233 —
National Clinical Research-Richmond, Inc Richmond Virginia 23294 —
Tidewater Clinical Research Virginia Beach Virginia 23456 —
Seattle Women's Health Research, Gynecology Seattle Washington 98105 —
North Spokane Women's Health Spokane Washington 99027 —

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 NCT01942668, 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 6, 2019 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01942668 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →