Conditions: Menopause
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 169
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Placebo arm 2: S-equol 20 mg total daily dose arm 3: S-equol 100 mg total daily dose arm 4: S-equol 300 mg total daily dose

Interventions: intervention 1: Placebo intervention 2: S-equol
Intervention descriptions: intervention 1: None intervention 2: 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)

Protocol document: