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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 is a Phase 3 study that has completed, run by Estetra. The registered enrollment target is 1,570 participants.
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04209543
The ClinicalTrials.gov registry entry for NCT04209543 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,570 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Estetra, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04209543 reports 0 study locations.
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.
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