Phytoserms for Menopause Symptoms and Age-Associated Memory Decline (phytoSERM)
Primary Purpose
Hot Flashes, Memory Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PhytoSERM tablet
placebo
Sponsored by
About this trial
This is an interventional other trial for Hot Flashes
Eligibility 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
Sites / Locations
- USC Keck School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
PhytoSERM 50 mg tablet
PhytoSERM 100 mg tablet
Placebo tablet
Arm Description
Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
Dietary supplement: placebo tablet to be taken once per day for 12 weeks
Outcomes
Primary Outcome Measures
safety and tolerability
as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance
efficacy
change from baseline in neuropsychological (cognitive, functional) test results
efficacy
change from baseline in vasomotor symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT01723917
First Posted
November 6, 2012
Last Updated
April 2, 2019
Sponsor
University of Southern California
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT01723917
Brief Title
Phytoserms for Menopause Symptoms and Age-Associated Memory Decline
Acronym
phytoSERM
Official Title
Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Memory Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PhytoSERM 50 mg tablet
Arm Type
Experimental
Arm Description
Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
Arm Title
PhytoSERM 100 mg tablet
Arm Type
Experimental
Arm Description
Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
Arm Title
Placebo tablet
Arm Type
Placebo Comparator
Arm Description
Dietary supplement: placebo tablet to be taken once per day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
PhytoSERM tablet
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
safety and tolerability
Description
as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance
Time Frame
12 weeks
Title
efficacy
Description
change from baseline in neuropsychological (cognitive, functional) test results
Time Frame
12 weeks
Title
efficacy
Description
change from baseline in vasomotor symptoms
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lon S Schneider, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30889096
Citation
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.
Results Reference
derived
PubMed Identifier
28926513
Citation
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.
Results Reference
derived
Learn more about this trial
Phytoserms for Menopause Symptoms and Age-Associated Memory Decline
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