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NCT04209543 · ClinicalTrials.gov registry record · Phase 3
Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)
A Phase 3 study, sponsored by Estetra.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,570
- Enrollment target
NCT04209543: Completed Phase 3 study, sponsored by Estetra.
NCT04209543 is a Phase 3 study that has completed, run by Estetra. The registered enrollment target is 1,570 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (103% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04209543, a Phase 3 study, has completed, sponsored by Estetra.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,570 participants
- Enrollment target
Study Summary
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)
Primary Outcome
The weekly frequency of moderate to severe VMS at Baseline and Week 4 is defined as the total number (sum) of all recorded moderate to severe VMS experienced during the last 7 consecutive days prior randomization for Baseline and at Week 4. Mean change = mean weekly frequency at Week 4 - mean weekly frequency at Baseline
Interventions
- DRUG Placebo
- DRUG Progesterone
- DRUG Estetrol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,570 participants |
| Start Date | 2019-12-30 |
| Est. Completion | 2024-02-08 |
| Phase | Phase 3 |
What the finished NCT04209543 record still lists
NCT04209543 is an interventional study that assigns participants to a tested intervention. Its 1,570 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 (103% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04209543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04209543 about?
NCT04209543 is a clinical study titled "Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)". 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)
What is the current status of trial NCT04209543?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,570 participants. The study started on 2019-12-30. Estimated completion is 2024-02-08.
What interventions are being tested in trial NCT04209543?
The interventions under investigation include: Placebo (DRUG), Progesterone (DRUG), Estetrol (DRUG).
Who is sponsoring clinical trial NCT04209543?
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 NCT04209543's enrollment target sits among peer trials
1,570 150th of 2000 higher than 1,851 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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