PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial
This is a proof-of-concept phase 2 clinical trial to investigate the effect of the phytoestrogenic supplement PhytoSERM on vasomotor symptoms and other symptoms associated with the menopausal transition, and on blood-based biomarkers in peri- and postmenopausal women. After the screening period, participants will be randomized to PhytoSERM 50 mg pills (administered orally, once per day) or matching placebo, 1:1 allocation, for a period of 12 weeks. After 12 weeks, all participants in the placebo group will be crossed-over to receive PhytoSERM pills for the remainder of the study (open-label phase).
• Peri- or postmenopausal women, defined by any of the following:
‣ Last menstrual period (LMP) completed ≥ 60 days and ≤ 8 years, per the Stages of Reproductive Aging Workshop (STRAW) criteria.
⁃ Post-hysterectomy or endometrial ablation ≥ 3 months and supported by FSH levels.
• Age 45-60 years.
• Presence of hot flashes ≥ 7 per day.
• Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be not clinically significant by the investigator.
• Mammogram within normal limits in the past 2 years: Breast Imaging Reporting and Data System (BI-RADS) category 1-2 or 3 with findings stable for 3 years.
• No medical contraindications to study participation.
• Stable medications for 4 weeks prior to the baseline visits.
• 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.