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

This study is currently recruiting participants.
Verified November 2012 by University of Southern California
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01723917
First received: November 6, 2012
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Hot Flashes
Memory Loss
Dietary Supplement: PhytoSERM tablet
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance

  • efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    change from baseline in neuropsychological (cognitive, functional) test results

  • efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    change from baseline in vasomotor symptoms


Estimated Enrollment: 78
Study Start Date: July 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   48 Years to 58 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • post-menopausal women
  • ages 48 - 58 (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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01723917

Locations
United States, California
USC Keck School of Medicine Recruiting
Los Angeles, California, United States, 90033
Contact: Gerson Hernandez, MD    323-442-5775    gersonhe@usc.edu   
Contact: Nadine Diaz, MSW    (323) 442-5775    ndiaz@usc.edu   
Principal Investigator: Lon Schneider, MD         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Lon S Schneider, MD University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01723917     History of Changes
Other Study ID Numbers: AG033288, R01AG033288
Study First Received: November 6, 2012
Last Updated: November 7, 2012
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Additional relevant MeSH terms:
Amnesia
Memory Disorders
Hot Flashes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014