Phytoserms for Menopause Symptoms and Age-Associated Memory Decline

Not Applicable

Completed

• Conditions: Memory Loss; Hot Flashes

• Registration Number: NCT01723917
• Lead Sponsor: University of Southern California

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of a soy based dietary supplement (phytoSERM) for hot flashes and age associated memory loss.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-07
• Study First Posted: 2012-11-08
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

Inclusion Criteria

• post-menopausal women
• ages 45 - 60 (inclusive)
• must have a vasomotor symptom (e.g., hot flash) and a memory complaint

Exclusion Criteria

• history of clinically significant stroke
• current evidence or history in past 2 years of epilepsy, seizure, focal brain lesion, head injury with loss of consciousness or any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
• Known allergy to soy derived products; hypersensitivity to estrogens or progestins

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
safety and tolerability	12 weeks	as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance
efficacy	12 weeks	change from baseline in vasomotor symptoms

Trial Locations

Locations (1)

USC Keck School of Medicine; 🇺🇸 Los Angeles, California, United States