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Estrogen Receptor Agonist

Estetrol 20 mg - Safety Part for Hot Flashes (E4Comfort Trial)

Phase 3
Waitlist Available
Research Sponsored by Estetra
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Awards & highlights

E4Comfort Trial Summary

This trial is testing a new drug, Estetrol (E4), to see if it can help reduce the severity and frequency of hot flashes in menopausal women. The study will also evaluate the safety of the drug.

Eligible Conditions
  • Hot Flashes
  • Menopause

E4Comfort Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in severity of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 12 (Efficacy part)
Mean change in severity of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 4 (Efficacy part)
Mean change in weekly frequency of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 12 (Efficacy part)
+8 more
Secondary outcome measures
Activated partial thromboplastin time (aPTT) based activated Protein C resistance (APCr) (Efficacy part)
Protein C Inhibitor
Endometrial biopsy histology at Screening and Week 53 (Efficacy part)
+57 more

E4Comfort Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Estetrol 20 mg - Safety PartExperimental Treatment1 Intervention
Estetrol (E4) 20 mg will be administered orally once daily for up to 53 weeks.
Group II: Estetrol 20 mg - Efficacy PartExperimental Treatment1 Intervention
Estetrol (E4) 20 mg will be administered orally once daily for up to 53 weeks.
Group III: Estetrol 15 mg - Efficacy PartExperimental Treatment1 Intervention
Estetrol (E4) 15 mg will be administered orally once daily for up to 53 weeks.
Group IV: Placebo - Efficacy PartPlacebo Group1 Intervention
Placebo will be administered orally once daily for up to 53 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estetrol oral tablet
2019
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

ICON Clinical ResearchIndustry Sponsor
49 Previous Clinical Trials
14,357 Total Patients Enrolled
EstetraLead Sponsor
15 Previous Clinical Trials
74,371 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Colorado
How old are they?
18 - 65
What site did they apply to?
Downtown Women's Health Care
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women
2019. "Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04090957.
~185 spots leftby Apr 2025
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