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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 is a Phase 3 study that has completed, run by Estetra. The registered enrollment target is 1,015 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04090957
The ClinicalTrials.gov registry entry for NCT04090957 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,015 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 2 interventions - of which Placebo oral tablet is the first listed.
NCT04090957 reports 0 study locations.
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.
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