Hot Flashes, Memory Loss
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPhytoSERM tablet
DIETARY_SUPPLEMENTplacebo
Sponsors
National Institute on Aging (NIA)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety and tolerability | 12 weeks | as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance |
| efficacy | 12 weeks | change from baseline in neuropsychological (cognitive, functional) test results |
Countries
United States
Outcome results
None listed