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Trial record 1 of 1 for:    phytoserm
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Phytoserms for Menopause Symptoms and Age-Associated Memory Decline (phytoSERM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01723917
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Lon Schneider, University of Southern California

Brief Summary:
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 or disease Intervention/treatment Phase
Hot Flashes Memory Loss Dietary Supplement: PhytoSERM tablet Dietary Supplement: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline
Study Start Date : July 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Menopause

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



Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723917


Locations
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United States, California
USC Keck School of Medicine
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Lon S Schneider, MD University of Southern California
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lon Schneider, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01723917    
Other Study ID Numbers: AG033288
R01AG033288 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Memory Disorders
Hot Flashes
Signs and Symptoms
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases