Phytoserms for Menopause Symptoms and Age-Associated Memory Decline
NCT ID: NCT01723917
Last Updated: 2019-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2012-07-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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PhytoSERM 50 mg tablet
Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
PhytoSERM tablet
PhytoSERM 100 mg tablet
Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
PhytoSERM tablet
Placebo tablet
Dietary supplement: placebo tablet to be taken once per day for 12 weeks
placebo
Interventions
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PhytoSERM tablet
placebo
Eligibility Criteria
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Inclusion Criteria
* ages 45 - 60 (inclusive)
* must have a vasomotor symptom (e.g., hot flash) and a memory complaint
Exclusion Criteria
* 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
45 Years
60 Years
FEMALE
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of Southern California
OTHER
Responsible Party
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Lon Schneider
Professor
Principal Investigators
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Lon S Schneider, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Keck School of Medicine
Los Angeles, California, United States
Countries
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References
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Schneider LS, Hernandez G, Zhao L, Franke AA, Chen YL, Pawluczyk S, Mack WJ, Brinton RD. Safety and feasibility of estrogen receptor-beta targeted phytoSERM formulation for menopausal symptoms: phase 1b/2a randomized clinical trial. Menopause. 2019 Aug;26(8):874-884. doi: 10.1097/GME.0000000000001325.
Hernandez G, Zhao L, Franke AA, Chen YL, Mack WJ, Brinton RD, Schneider LS. Pharmacokinetics and safety profile of single-dose administration of an estrogen receptor beta-selective phytoestrogenic (phytoSERM) formulation in perimenopausal and postmenopausal women. Menopause. 2018 Feb;25(2):191-196. doi: 10.1097/GME.0000000000000984.
Other Identifiers
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AG033288
Identifier Type: -
Identifier Source: org_study_id
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