At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,015 enrolled
Drug / intervention
Estetrol oral tablet +1 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 II)
In Brief
A Phase 3 clinical trial evaluating Estetrol oral tablet and Placebo oral tablet for Vasomotor Symptoms and Menopausal Symptoms. Completed, enrolled 1,015 participants across 117 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVasomotor Symptoms, Menopausal Symptoms
CountriesCanada, United States
CollaboratorsICON Clinical Research
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartSep 2019
Primary CompletionAug 2022
TodayJul 2026
First PostedSep 16, 2019
Enrollment StartSep 27, 2019
Primary CompletionAug 18, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.8 years ago
Interventions
Estetrol oral tabletdrug
Estetrol oral tablet, administered orally once daily.
Placebo oral tabletdrug
Placebo oral tablet, administered orally once daily.