Trial record 1 of 1 for:    Estrogen Receptor-beta phytoSERMs for Management
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Phytoserms for Menopause Symptoms and Age-Associated Memory Decline (phytoSERM)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014