PhytoSERM Efficacy to Prevent Menopause Associated Decline in Brain Metabolism and Cognition: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial
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.
• 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.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
⁃ Ability to take oral medication and be willing to adhere to the PhytoSERM regimen.
⁃ For females of reproductive potential: Negative pregnancy test and use of highly effective contraception by male partner for at least 1 month prior to screening and agreement to use such a method during study participation.
⁃ Fluent in English or Spanish.