ClinicalTrials.gov record
Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II)
ClinicalTrials.gov ID: NCT04090957
Public ClinicalTrials.gov record NCT04090957. 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 II)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A two-part study designed to evaluate the effect of Estetrol (E4) 15 mg, 20 mg, or placebo on the severity and frequency of vasomotor symptoms (VMS) in the Efficacy Study Part and the safety of E4 20 mg in the Safety Study Part.
Study identification
- NCT ID
- NCT04090957
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,015 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
- Sep 27, 2019 (Actual)
- Primary completion
- Aug 18, 2022 (Actual)
- Completion
- Aug 18, 2022 (Actual)
- Last update posted
- Dec 26, 2025
2019 – 2022
United States locations
- U.S. sites
- 111
- U.S. states
- 27
- U.S. cities
- 85
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Estetra Study Site | Birmingham | Alabama | 35205 | — |
| Estetra Study Site | Birmingham | Alabama | 35218 | — |
| Estetra Study Site | Birmingham | Alabama | 35235 | — |
| Estetra Study Site | Dothan | Alabama | 36303-1928 | — |
| Estetra Study Site | Phoenix | Arizona | 85018 | — |
| Estetra Study Site | Phoenix | Arizona | 85032 | — |
| Estetra Study Site | Tempe | Arizona | 85281 | — |
| Estetra Study Site | Tucson | Arizona | 85704 | — |
| Estetra Study Site | Tucson | Arizona | 85712 | — |
| Estetra Study Site | Tucson | Arizona | 85715 | — |
| Estetra Study Site | Tucson | Arizona | 85745 | — |
| Estetra Study Site | Little Rock | Arkansas | 72204 | — |
| Estetra Study Site | Bellflower | California | 90706 | — |
| Estetra Study Site | Canoga Park | California | 91303 | — |
| Estetra Study Site | Chula Vista | California | 91911 | — |
| Estetra Study Site | Huntington Beach | California | 92647 | — |
| Estetra Study Site | La Mesa | California | 91942 | — |
| Estetra Study Site | Lincoln | California | 95648 | — |
| Estetra Study Site | Los Angeles | California | 90057 | — |
| Estetra Study Site | Pomona | California | 91767 | — |
| Estetra Study Site | Sacramento | California | 95821 | — |
| Estetra Study Site | San Diego | California | 92111 | — |
| Estetra Study Site | San Diego | California | 92120 | — |
| Estetra Study Site | Santa Ana | California | 92705 | — |
| Estetra Study Site | Thousand Oaks | California | 91360 | — |
| Estetra Study Site | West Covina | California | 91790 | — |
| Estetra Study Site | Colorado Springs | Colorado | 80918 | — |
| Estetra Study Site | Denver | Colorado | 80209 | — |
| Estetra Study Site | Crystal River | Florida | 34429 | — |
| Estetra Study Site | Jacksonville | Florida | 32207 | — |
| Estetra Study Site | Jacksonville | Florida | 32256 | — |
| Estetra Study Site | Miami | Florida | 33134 | — |
| Estetra Study Site | Miami | Florida | 33155 | — |
| Estetra Study Site | Miami | Florida | 33173 | — |
| Estetra Study Site | Miami Lakes | Florida | 33014 | — |
| Estetra Study Site | New Port Richey | Florida | 34653 | — |
| Estetra Study Site | Ocoee | Florida | 34761 | — |
| Estetra Study Site | Orlando | Florida | 32801 | — |
| Estetra Study Site | Sarasota | Florida | 34239-3132 | — |
| Estetra Study Site | West Palm Beach | Florida | 33409 | — |
| Estetra Study Site | Atlanta | Georgia | 30342 | — |
| Estetra Study Site | Morrow | Georgia | 30260 | — |
| Estetra Study Site | Sandy Springs | Georgia | 30328 | — |
| Estetra Study Site | Savannah | Georgia | 31406 | — |
| Estetra Study Site | Idaho Falls | Idaho | 83404 | — |
| Estetra Study Site | Meridian | Idaho | 83642 | — |
| Estetra Study Site | Evansville | Indiana | 47714 | — |
| Estetra Study Site | Marrero | Louisiana | 70072 | — |
| Estetra Study Site | Saginaw | Michigan | 48602 | — |
| Estetra Study Site | Saginaw | Michigan | 48604 | — |
| Estetra Study Site | Rochester | Minnesota | 55905 | — |
| Estetra Study Site | St Louis | Missouri | 63141 | — |
| Estetra Study Site | Lincoln | Nebraska | 68510 | — |
| Estetra Study Site | Norfolk | Nebraska | 68701 | — |
| Estetra Study Site | Las Vegas | Nevada | 89106 | — |
| Estetra Study Site | Las Vegas | Nevada | 89128 | — |
| Estetra Study Site | Albuquerque | New Mexico | 87102 | — |
| Estetra Study Site | Albuquerque | New Mexico | 87109-4640 | — |
| Estetra Study Site | New York | New York | 10032 | — |
| Estetra Study Site | Charlotte | North Carolina | 28209 | — |
| Estetra Study Site | Charlotte | North Carolina | 28277 | — |
| Estetra Study Site | Columbus | North Carolina | 28412 | — |
| Estetra Study Site | Fayetteville | North Carolina | 28304 | — |
| Estetra Study Site | Hickory | North Carolina | 28601 | — |
| Estetra Study Site | New Bern | North Carolina | 28562 | — |
| Estetra Study Site | Raleigh | North Carolina | 27609 | — |
| Estetra Study Site | Raleigh | North Carolina | 27612 | — |
| Estetra Study Site | Rocky Mount | North Carolina | 27804 | — |
| Estetra Study Site | Cincinnati | Ohio | 45212 | — |
| Estetra Study Site | Cincinnati | Ohio | 45267 | — |
| Estetra Study Site | Cleveland | Ohio | 44122 | — |
| Estetra Study Site | Columbus | Ohio | 43213 | — |
| Estetra Study Site | Columbus | Ohio | 43231 | — |
| Estetra Study Site | Fairfield | Ohio | 45014 | — |
| Estetra Study Site | Erie | Pennsylvania | 16507 | — |
| Estetra Study Site | Philadelphia | Pennsylvania | 19114 | — |
| Estetra Study Site | Bluffton | South Carolina | 29910 | — |
| Estetra Study Site | Columbia | South Carolina | 29201 | — |
| Estetra Study Site | Mt. Pleasant | South Carolina | 29464 | — |
| Estetra Study Site | Myrtle Beach | South Carolina | 29572 | — |
| Estetra Study Site | North Charleston | South Carolina | 29405 | — |
| Estetra Study Site | Chattanooga | Tennessee | 37404 | — |
| Estetra Study Site | Jefferson City | Tennessee | 37760 | — |
| Estetra Study Site | Knoxville | Tennessee | 37912 | — |
| Estetra Study Site | Knoxville | Tennessee | 37938 | — |
| Estetra Study Site | Memphis | Tennessee | 38119 | — |
| Estetra Study Site | Memphis | Tennessee | 38120 | — |
| Estetra Study Site | Dallas | Texas | 75251 | — |
| Estetra Study Site | Fort Worth | Texas | 76104 | — |
| Estetra Study Site | Fort Worth | Texas | 76140 | — |
| Estetra Study Site | Georgetown | Texas | 78626 | — |
| Estetra Study Site | Houston | Texas | 77023 | — |
| Estetra Study Site | Houston | Texas | 77024 | — |
| Estetra Study Site | Houston | Texas | 77054 | — |
| Estetra Study Site | Houston | Texas | 77081 | — |
| Estetra Study Site | Houston | Texas | 77084 | — |
| Estetra Study Site | Houston | Texas | 77099 | — |
| Estetra Study Site | McAllen | Texas | 78503 | — |
| Estetra Study Site | McAllen | Texas | 78504 | — |
| Estetra Study Site | Pearland | Texas | 77581 | — |
| Estetra Study Site | Plano | Texas | 75093 | — |
| Estetra Study Site | San Antonio | Texas | 78258 | — |
| Estetra Study Site | Draper | Utah | 84020 | — |
| Estetra Study Site | Pleasant Grove | Utah | 84062 | — |
| Estetra Study Site | West Jordan | Utah | 84088 | — |
| Estetra Study Site | Charlottesville | Virginia | 22911 | — |
| Estetra Study Site | Norfolk | Virginia | 23507 | — |
| Estetra Study Site | Virginia Beach | Virginia | 23456 | — |
| Estetra Study Site | Bellevue | Washington | 98007 | — |
| Estetra Study Site | Seattle | Washington | 98105 | — |
| Estetra Study Site | 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 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04090957, 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 Dec 26, 2025 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04090957 live on ClinicalTrials.gov.