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Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II)

NCT04090957 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1015

Last updated 2025-12-26

Study results available
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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.

Conditions

Interventions

DRUG

Estetrol oral tablet

Estetrol oral tablet, administered orally once daily.

DRUG

Placebo oral tablet

Placebo oral tablet, administered orally once daily.

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Estetra

    lead INDUSTRY

Principal Investigators

  • Estetra · Estetra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2022-08-18
Completion
2022-08-18
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090957 on ClinicalTrials.gov