Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)
Public ClinicalTrials.gov record NCT04209543. 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 Randomized Double-blind Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a two-part study designed to evaluate the effect of Estetrol (E4) 15 or 20 mg, or placebo on the severity and frequency of vasomotor symptoms (VMS) (Efficacy Study Part) and the safety of E4 20 mg (Endometrial and General Safety Study Part)
Study identification
- NCT ID
- NCT04209543
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,570 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 65 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
- Dec 30, 2019 (Actual)
- Primary completion
- Feb 8, 2024 (Actual)
- Completion
- Feb 8, 2024 (Actual)
- Last update posted
- Jan 29, 2025
2019 – 2024
United States locations
- U.S. sites
- 65
- U.S. states
- 22
- U.S. cities
- 55
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Estetra Study Site | Birmingham | Alabama | 35218 | — |
| Estetra Study Site | Mesa | Arizona | 85206 | — |
| Estetra Study Site | Phoenix | Arizona | 85018 | — |
| Precision Trials AZ, LLC | Phoenix | Arizona | 85032 | — |
| Noble Clinical Research | Tucson | Arizona | 85704 | — |
| Hope Clinical Research, LLC | Canoga Park | California | 91303 | — |
| Estetra Study Site | Pomona | California | 91767 | — |
| Clinical Trials Research | Sacramento | California | 95821 | — |
| Estetra Study Site | Sacramento | California | 95821 | — |
| Estetra Study Site | Thousand Oaks | California | 91360 | — |
| Estetra Study Site | West Covina | California | 91790 | — |
| Velocity Clinical Research | Denver | Colorado | 80209 | — |
| Estetra Study Site | Altamonte Springs | Florida | 32701 | — |
| Estetra Study Site | Coconut Creek | Florida | 33073 | — |
| Estetra Study Site | Hialeah | Florida | 33016 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | — |
| Altus Research | Lake Worth | Florida | 33461 | — |
| Medical Research Center of Miami II | Miami | Florida | 33134 | — |
| Miami Clinical Research | Miami | Florida | 33155 | — |
| Genoma Research Group, Inc. | Miami | Florida | 33165 | — |
| Estetra Study Site | Miami | Florida | 33186 | — |
| San Marcus Research Clinic, Inc. | Miami Lakes | Florida | 33014 | — |
| Estetra Study Site | New Port Richey | Florida | 34653 | — |
| Estetra Study Site | North Miami | Florida | 33161 | — |
| Estetra Study Site | Ocoee | Florida | 34761 | — |
| Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare | Orlando | Florida | 32801 | — |
| Estetra Study Site | Ormond Beach | Florida | 32174 | — |
| Estetra Study Site | Palm Harbor | Florida | 34684 | — |
| Estetra Study Site | Pembroke Pines | Florida | 33027 | — |
| Estetra Study Site | Pinellas Park | Florida | 33782 | — |
| Estetra Study Site | Port Saint Lucie | Florida | 34952 | — |
| Physician Care Clinical Research, LLC | Sarasota | Florida | 34239 | — |
| Estetra Study Site | Tampa | Florida | 33609 | — |
| Estetra Study Site | Atlanta | Georgia | 30342 | — |
| Infinite Clinical Trials | Morrow | Georgia | 30260 | — |
| Fellows Research Alliance, Inc. | Savannah | Georgia | 31406 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | — |
| Praetorian Pharmaceutical Research | Marrero | Louisiana | 70072 | — |
| Meridian Clinical Research | Norfolk | Nebraska | 68701 | — |
| Jubilee Clinical Research, Inc | Las Vegas | Nevada | 89106 | — |
| Excel Clinical Research | Las Vegas | Nevada | 89109 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Bosque Women's Care | Albuquerque | New Mexico | 87109-4640 | — |
| PMG Research of Charlotte, LLC | Charlotte | North Carolina | 28209 | — |
| Estetra Study Site | Durham | North Carolina | 27713 | — |
| Estetra Study Site | Columbus | Ohio | 43231 | — |
| Estetra Study Site | Englewood | Ohio | 45322 | — |
| Estetra Study Site | Philadelphia | Pennsylvania | 19114 | — |
| Magnolia Ob/Gyn Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Estetra Study Site | Chattanooga | Tennessee | 37404 | — |
| Cedar Health Research, LLC | Dallas | Texas | 75251 | — |
| Signature Gyn Services | Fort Worth | Texas | 76140 | — |
| Estetra Study Site | Houston | Texas | 77054 | — |
| Biopharma Informatic, Inc. Research Center | Houston | Texas | 77084 | — |
| Estetra Study Site | Houston | Texas | 77084 | — |
| Cedar Health Research LLC | Irving | Texas | 75062 | — |
| Estetra Study Site | Plano | Texas | 75093 | — |
| Estetra Study Site | San Antonio | Texas | 78229 | — |
| Estetra Study Site | San Antonio | Texas | 78233 | — |
| Estetra Study Site | San Antonio | Texas | 78258 | — |
| Estetra Study Site | Pleasant Grove | Utah | 84062 | — |
| Estetra Study Site | Norfolk | Virginia | 23507 | — |
| Tidewater Clinical Research Inc | Virginia Beach | Virginia | 23456 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| IMA Clinical Research | Morgantown | West Virginia | 26505 | — |
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 159 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04209543, 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 Jan 29, 2025 · 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 NCT04209543 live on ClinicalTrials.gov.