At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 169 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
S-equol 10 mgfrom 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.
Randomized, Double Blind, Multicenter, Placebo Controlled, Proof of Concept Trial to Assess the Efficacy and Safety of 4 Weeks Treatment With AUS-131 (S-equol) on Vasomotor Symptoms in Menopausal Patients
In Brief
A Phase 2 clinical trial evaluating Placebo and S-equol for Menopause. Completed, enrolled 169 participants across 9 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the safety and effectiveness of S-equol in menopausal patients with hot flushes and night sweats.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause
CountriesAustralia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2009
Enrollment StartJun 2010
Primary CompletionNov 2011
TodayJul 2026
First PostedAug 20, 2009
Enrollment StartJun 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.9 years ago
Interventions
Placebodrug
S-equoldrug
Eligible patients meeting all study entry criteria were randomly assigned to receive one of the following active treatments for 4 weeks: * S-equol 10 mg BID (20 mg total daily dose) * S-equol 50 mg BID (100 mg total daily dose) * S-equol 150 mg BID (300 mg total daily dose)