PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health — HF-Relief  

Menopause Clinical Trial

Official title: PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

This is a double-blinded, randomized, placebo-controlled, parallel designed, proof-of-concept phase 2 clinical trial to determine effect of PhytoSERM on vasomotor symptoms and other symptoms associated with the menopausal transition. PhytoSERM or placebo pills will be administered orally once a day over 24 weeks. Safety and tolerability will also be assessed over the duration of the study.

A total of 132 peri- or postmenopausal women aged 45-60 years and who are experiencing hot flashes will be enrolled in this trial. To determine eligibility, all participants will undergo cognitive assessment, physical assessment, ECG, clinical/safety laboratory assessment, and interviews. After a 2-week screening period, participants will be randomized to study intervention (PhytoSERM 50mg administered orally, once per day) or matching placebo, in a 1:1 allocation. After 12 weeks, participants in the placebo group will be crossed-over to PhytoSERM 50 mg for the remaining 12 weeks (open-label extension period). Hot flashes will be measured both objectively and subjectively. Objective data will be skin conductance levels collected via a wearable device that enables real-time physiological data acquisition, including activity and sleep data. Study participants will be asked to complete a total of 8 study visits. Study visits will occur at 4-week intervals after the baseline, except for visits # 6 and 7 (open-label period) which will occur at 6-week intervals after visit # 5 (final outcomes assessments visit). Visits 1, 2, 5 and 7 will last approximately 2-4 hours; visits 3, 4, 6 and 8 will last approximately 45 minutes.

All participants will be enrolled at a single site, at the University of Arizona (UA) Clinical & Translational Sciences Research Center (CATS). ;

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

• NCT number: NCT06186531
• Study type: Interventional
• Source: NeuTherapeutics
• Contact: Claudia M Lopez, BSc
• Phone: 520-626-6276
• Email: claudiml@arizona.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: November 17, 2023
• Completion date: November 15, 2024