Phytoserms for Menopause Symptoms and Age-Associated Memory Decline

University of Southern California71 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Hot Flashes Memory Loss

Interventions

PhytoSERM tabletDIETARY_SUPPLEMENT

placeboDIETARY_SUPPLEMENT

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

USC Keck School of Medicine

Los Angeles, California, United States

Outcomes

Primary Outcomes

safety and tolerability

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

Time frame: 12 weeks

efficacy

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

Time frame: 12 weeks

efficacy

change from baseline in vasomotor symptoms

Time frame: 12 weeks

Data from ClinicalTrials.gov

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