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OpenTrials
Completed

NCT Number: NCT01723917

Phytoserms for Menopause Symptoms 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.

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Key information

Conditions

Hot Flashes Memory Disorders Memory Loss Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

USC Keck School of Medicine

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PhytoSERM tablet

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. safety and tolerability

    Time frame: 12 weeks

    as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance

  2. efficacy

    Time frame: 12 weeks

    change from baseline in neuropsychological (cognitive, functional) test results

  3. efficacy

    Time frame: 12 weeks

    change from baseline in vasomotor symptoms

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: phytoSERM

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 8, 2012
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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