Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 71
- Locations
- 2
- Primary Endpoint
- safety and tolerability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 60 Years (Adult)
- Sex
- 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
Arms & Interventions
PhytoSERM 50 mg tablet
Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
Intervention: PhytoSERM tablet (Dietary Supplement)
PhytoSERM 100 mg tablet
Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
Intervention: PhytoSERM tablet (Dietary Supplement)
Placebo tablet
Dietary supplement: placebo tablet to be taken once per day for 12 weeks
Intervention: placebo (Dietary Supplement)
Outcomes
Primary Outcomes
safety and tolerability
Time Frame: 12 weeks
as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance
efficacy
Time Frame: 12 weeks
change from baseline in neuropsychological (cognitive, functional) test results
Secondary Outcomes
No secondary outcomes reported
Investigators
Lon Schneider
Professor
University of Southern California