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NCT04090957 · ClinicalTrials.gov registry record · Phase 3
Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II)
A Phase 3 study, sponsored by Estetra.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,015
- Enrollment target
NCT04090957: Completed Phase 3 study, sponsored by Estetra.
NCT04090957 is a Phase 3 study that has completed, run by Estetra. The registered enrollment target is 1,015 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04090957, a Phase 3 study, has completed, sponsored by Estetra.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,015 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Weekly frequency of moderate to severe VMS at Baseline = total number (sum) of all recorded moderate to severe VMS experienced during the last 7 consecutive days prior randomization (Week 0). Weekly frequency of moderate to severe VMS at Week X = total number (sum) of all recorded moderate to severe VMS experienced during the week X.
Interventions
- DRUG Placebo oral tablet
- DRUG Estetrol oral tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,015 participants |
| Start Date | 2019-09-27 |
| Est. Completion | 2022-08-18 |
| Phase | Phase 3 |
What the finished NCT04090957 record still lists
NCT04090957 is an interventional study that assigns participants to a tested intervention. Its 1,015 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04090957 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04090957 about?
NCT04090957 is a clinical study titled "Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II)". 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.
What is the current status of trial NCT04090957?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,015 participants. The study started on 2019-09-27. Estimated completion is 2022-08-18.
What interventions are being tested in trial NCT04090957?
The interventions under investigation include: Placebo oral tablet (DRUG), Estetrol oral tablet (DRUG).
Who is sponsoring clinical trial NCT04090957?
This trial is sponsored by Estetra, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04090957's enrollment target sits among peer trials
1,015 294th of 2000 higher than 1,707 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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