NCT01723917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

November 6, 2012

Last Update Submit

April 2, 2019

Conditions

Hot FlashesMemory Loss

Outcome Measures

Primary Outcomes (3)

  • safety and tolerability

    as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance

    12 weeks

  • efficacy

    change from baseline in neuropsychological (cognitive, functional) test results

    12 weeks

  • efficacy

    change from baseline in vasomotor symptoms

    12 weeks

Study Arms (3)

PhytoSERM 50 mg tablet

EXPERIMENTAL

Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks

Dietary Supplement: PhytoSERM tablet

PhytoSERM 100 mg tablet

EXPERIMENTAL

Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks

Dietary Supplement: PhytoSERM tablet

Placebo tablet

PLACEBO COMPARATOR

Dietary supplement: placebo tablet to be taken once per day for 12 weeks

Dietary Supplement: placebo

Interventions

PhytoSERM tabletDIETARY_SUPPLEMENT
PhytoSERM 100 mg tabletPhytoSERM 50 mg tablet
placeboDIETARY_SUPPLEMENT
Placebo tablet

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • post-menopausal women
  • ages 45 - 60 (inclusive)
  • must have a vasomotor symptom (e.g., hot flash) and a memory complaint

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Related Publications (2)

  • 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.

    PMID: 30889096DERIVED

  • 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.

    PMID: 28926513DERIVED

MeSH Terms

Conditions

Hot FlashesMemory Disorders

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System Diseases

Study Officials

  • Lon S Schneider, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 6, 2012

First Posted

November 8, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 4, 2019

Record last verified: 2019-04

Locations

US(1)