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PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health

NCT06186531 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2024-01-02

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Arizona

    collaborator OTHER

  • NeuTherapeutics

    lead INDUSTRY

Principal Investigators

  • Fei Yin, PhD · University of Arizona

  • Gerson D Hernandez, MD, MPH · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-17
Primary Completion
2024-11-15
Completion
2024-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06186531 on ClinicalTrials.gov