Phytoserms for Menopause Symptoms and Age-Associated Memory Decline

Hot Flashes Clinical Trial

— phytoSERM  

Official title:

Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723917
• Other study ID #: AG033288
• Secondary ID: R01AG033288
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: January 2015

Study information

• Verified date: April 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hot Flashes
• Memory Disorders
• Memory Loss

Intervention

Dietary Supplement:
• PhytoSERM tablet

• placebo

Locations

Country	Name	City	State
United States	USC Keck School of Medicine	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability	as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance	12 weeks
Primary	efficacy	change from baseline in neuropsychological (cognitive, functional) test results	12 weeks
Primary	efficacy	change from baseline in vasomotor symptoms	12 weeks