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

NCT00962585 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2014-04-08

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Ausio Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Michael A Thomas, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States
  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00962585 on ClinicalTrials.gov