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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.

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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

FieldValue
Enrollment Target 1,570 participants
Start Date 2019-12-30
Est. Completion 2024-02-08
Phase Phase 3

Sponsor

Estetra

5 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.