PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition (NCT05664477) | Clinical Trial Compass
Active — Not RecruitingPhase 2
PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition
United States100 participantsStarted 2024-01-10
Plain-language summary
This is a proof-of-concept phase 2 clinical trial to investigate the safety and effect of the phytoestrogenic supplement PhytoSERM on regional brain metabolism by fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in peri- and postmenopausal women. The investigators hypothesize that there will be a significant difference between the PhytoSERM group and placebo group in glucose brain metabolism.
Who can participate
Age range45 Years – 60 Years
SexALL
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Inclusion criteria
✓. Peri- or postmenopausal women with the latter defined as last menstrual period (LMP) completed ≥ 60 days and ≤ 4 years, per the Stages of Reproductive Aging Workshop (STRAW) criteria.
✓. Age 45-60 years.
✓. Presence of hot flashes ≥ 7 per day.
✓. In good general health as evidenced by medical history.
✓. Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be not clinically significant by the investigator.
✓. No medical contraindications to study participation.
✓. Stable medications for 4 weeks prior to the baseline visits.
✓. Provision of signed and dated informed consent form.
Exclusion criteria
✕. Known allergies to isoflavones or soy-based products.
✕. Evidence of cognitive impairment on the Mini-Mental State Examination (total score \< 27).
✕. Pregnancy
✕. Use of estrogen or progestin compounds within 8 weeks of baseline.
✕. Use of investigational agent within 12 weeks of baseline.
✕
What they're measuring
1
Standardized uptake value ratio (SUVR) by 18F-FDG PET
. Concurrent neurologic, systemic, or psychiatric disease that would influence cognition or ability to provide informed consent and to participate.
✕. Known or suspected estrogen-dependent neoplasia, active neoplastic disease, history of breast cancer, or at risk of developing breast cancer, endometrial hyperplasia.
✕. History of epilepsy, focal brain lesion, head injury with loss of consciousness or Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.