phytoSERM: Phytoserms for Menopause Symptoms and Age-Associated Memory Decline

• Sponsor: University of Southern California (Other)
• Overall Status: Completed
• CT.gov ID: NCT01723917
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 71
• Location: 1
• Arms: 3
• Duration (Months): 30
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hot Flashes; Memory Loss	Dietary Supplement: PhytoSERM tablet; Dietary Supplement: placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PhytoSERM 50 mg tablet Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks	Dietary Supplement: PhytoSERM tablet
Experimental: PhytoSERM 100 mg tablet Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks	Dietary Supplement: PhytoSERM tablet
Placebo Comparator: Placebo tablet Dietary supplement: placebo tablet to be taken once per day for 12 weeks	Dietary Supplement: placebo

Outcome Measures

Primary Outcome Measures

1. safety and tolerability [12 weeks]

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

2. efficacy [12 weeks]

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

3. efficacy [12 weeks]

   change from baseline in vasomotor symptoms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC Keck School of Medicine	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Lon S Schneider, MD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lon Schneider, Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT01723917
• Other Study ID Numbers: AG033288; R01AG033288
• First Posted: Nov 8, 2012
• Last Update Posted: Apr 4, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Memory Disorders; Hot Flashes

Study Results

No Results Posted as of Apr 4, 2019