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

NCT04209543 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1570

Last updated 2025-01-29

No results posted yet for this 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)

Conditions

Interventions

DRUG

Estetrol

Estetrol oral tablet: administered orally once daily

DRUG

Placebo

Placebo oral tablet: administered orally once daily

DRUG

Progesterone

Progesterone oral tablet: administered orally once daily

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Estetra

    lead INDUSTRY

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
2019-12-30
Primary Completion
2024-02-08
Completion
2024-02-08
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Czechia
  • Hungary
  • Italy
  • Lithuania
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT04209543 on ClinicalTrials.gov