At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,570 enrolled
Drug / intervention
Estetrol +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Double-blind Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)
In Brief
A Phase 3 clinical trial evaluating Estetrol, Placebo, and 1 other intervention for Vasomotor Symptoms and Menopausal Symptoms. Completed, enrolled 1,570 participants across 224 sites in 14 countries.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVasomotor Symptoms, Menopausal Symptoms
CountriesArgentina, Brazil, Canada, Czechia, Hungary, Italy, Lithuania, Poland, Romania, Russia, Slovakia, Spain, United Kingdom, United States
CollaboratorsICON Clinical Research
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 2019
Enrollment StartDec 2019
Primary CompletionFeb 2024
TodayJul 2026
First PostedDec 24, 2019
Enrollment StartDec 30, 2019
Primary CompletionFeb 8, 2024
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 6.5 years ago
Interventions
Estetroldrug
Estetrol oral tablet: administered orally once daily
Placebodrug
Placebo oral tablet: administered orally once daily
Progesteronedrug
Progesterone oral tablet: administered orally once daily