NCT00962585

Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Ausio Pharmaceuticals, LLC · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The study is a randomized, double blind, multicenter, placebo controlled, parallel group, proof of concept study comparing the efficacy, safety, and acceptability of 3 doses of S-equol to placebo in menopausal patients with vasomotor symptoms. The study objective is an evaluation of the dose response of 3 dose levels of AUS-131 (S-equol) and placebo with respect to reducing the mean number of moderate to severe vasomotor symptoms after 4 weeks of treatment. The safety of S-equol will be evaluated during the study.

Conditions

• Menopause

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	S-equol	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)

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2009-08-20
• Last updated: 2014-04-08
• Results posted: 2014-04-08

Locations

9 sites across 2 countries: United States, Australia