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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

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

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: 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

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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