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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by University of Southern California.
Recruitment status was  Recruiting
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

November 6, 2012
November 7, 2012
July 2012
June 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01723917 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phytoserms for Menopause Symptoms and Age-Associated Memory Decline
Estrogen Receptor-beta phytoSERMs for Management of Menopause 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Hot Flashes
  • Memory Loss
  • Dietary Supplement: PhytoSERM tablet
  • Dietary Supplement: placebo
  • Experimental: PhytoSERM 50 mg tablet
    Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
    Intervention: Dietary Supplement: PhytoSERM tablet
  • Experimental: PhytoSERM 100 mg tablet
    Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
    Intervention: Dietary Supplement: PhytoSERM tablet
  • Placebo Comparator: Placebo tablet
    Dietary supplement: placebo tablet to be taken once per day for 12 weeks
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
78
September 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
48 Years to 58 Years
No
United States
 
NCT01723917
AG033288, R01AG033288
Yes
University of Southern California
University of Southern California
National Institute on Aging (NIA)
Principal Investigator: Lon S Schneider, MD University of Southern California
University of Southern California
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP