Phytoserms for Menopause Symptoms and Age-Associated Memory Decline (phytoSERM)

April 2, 2019 updated by: Lon Schneider, University of Southern California

Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC Keck School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PhytoSERM 50 mg tablet
Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
Dietary supplement: PhytoSERM tablet
Experimental: PhytoSERM 100 mg tablet
Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
Dietary supplement: PhytoSERM tablet
Placebo Comparator: Placebo tablet
Dietary supplement: placebo tablet to be taken once per day for 12 weeks
Dietary supplement: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety and tolerability
Time Frame: 12 weeks
as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance
12 weeks
efficacy
Time Frame: 12 weeks
change from baseline in neuropsychological (cognitive, functional) test results
12 weeks
efficacy
Time Frame: 12 weeks
change from baseline in vasomotor symptoms
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Lon S Schneider, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 6, 2012

First Submitted That Met QC Criteria

November 7, 2012

First Posted (Estimate)

November 8, 2012

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG033288
  • R01AG033288 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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