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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
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hot Flashes

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
November 6, 2012
Last Updated
April 2, 2019
Sponsor
University of Southern California
Collaborators
National Institute on Aging (NIA)
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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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