NCT06186531

PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: NeuTherapeutics · Industry
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Menopause
• Hot Flashes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PhytoSERM	PhytoSERM, a formulated dietary supplement, will be an ovalized tablet measuring 8.51 mm x 15.49 mm. Each pill will contain a white PEG coating and an equal mixture of, daidzein, genistein, and S-equol.
DRUG	Placebo	Placebo product is of identical shape, size and color with a white PEG coating but without S-equol, daidzein and genistein.

Timeline

• Start date: 2023-11-17
• Primary completion: 2024-11-15
• Completion: 2024-11-15
• First posted: 2024-01-02
• Last updated: 2024-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study