Efficacy and Safety of S-Equol on Vasomotor Symptoms in Menopausal Patients
| Status: | Archived |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | June 2010 |
| End Date: | August 2010 |
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
The purpose of this study is to assess the safety and effectiveness of S-equol in menopausal
patients with hot flushes and night sweats.
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.
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