PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health

NCT06186531 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: Phyto-HF-2022-01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Menopause; Hot Flashes

Keywords

Phytoestrogen supplement; Menopause; Hot flashes; Cognition

Outcome Measures

Primary Outcomes (1)

• Hot Flash Composite score

  Composite score comprised by hot flash frequency and severity (sum of weekly hot flashes weighted by severity: mild, moderate, severe). Higher score indicates a bad outcome. No minimum or maximum values.

  Daily from baseline to week 24

Secondary Outcomes (12)

• Trail Making Test score

  Baseline, week 4, 8, 12 and 24.

• NIH Toolbox List Sorting Working Memory Test score

  Baseline, week 4, 8, 12 and 24.

• NIH Toolbox Picture Sequence Memory Test

  Baseline, week 4, 8, 12 and 24.

• NIH Toolbox Auditory Verbal Learning Test

  Baseline, week 4, 8, 12 and 24.

• NIH Toolbox Oral Symbol Digit Test

  Baseline, week 4, 8, 12 and 24.

Other Outcomes (9)

• Digital hot flash frequency

  Daily from baseline to week 28.

• Follicle-Stimulating Hormone (FSH) levels

  Baseline, weeks 12 and 24

• Estrodiol levels

  Baseline, weeks 12 and 24

Study Arms (2)

PhytoSERM

EXPERIMENTAL

Active intervention group

Dietary Supplement: PhytoSERM

Placebo group

PLACEBO COMPARATOR

Control group

Drug: Placebo

Interventions

PhytoSERM DIETARY_SUPPLEMENT

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.

PhytoSERM

Placebo DRUG

Placebo product is of identical shape, size and color with a white PEG coating but without S-equol, daidzein and genistein.

Placebo group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: Peri and postmenopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Use of isoflavone containing supplements.
• Known allergies to isoflavones or soy-based products.
• Montreal Cognitive Assessment total score \< 22.
• Pregnancy
• Use of estrogen or progestin compounds within 8 weeks of baseline.
• Use of investigational agent within 12 weeks of baseline.
• Concurrent neurologic, systemic, or psychiatric disease that would influence cognition or ability to provide informed consent and to participate.
• Known or suspected estrogen-dependent neoplasia (breast, ovarian and uterine cancers), active neoplastic disease, history of breast cancer, and endometrial hyperplasia.
• History within the last 5 years of any other primary or recurrent malignant disease, with the exception of resected cutaneous squamous cell carcinoma in situ, and basal cell carcinoma.
• History of epilepsy, focal brain lesion, head injury with loss of consciousness or DSM IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol, or substance abuse.
• Thrombophlebitis, thrombosis, thromboembolic disorders, myocardial infarction, ischemic heart disease, cerebrovascular accident, stroke, TIA.
• Current use of tobacco or a history of alcohol abuse.
• Use of anticoagulants.
• Chronic use of most benzodiazepines
• Use of drugs, herbs, or dietary supplements to treat menopausal or cognitive symptoms less than 8 weeks prior to baseline (e.g., SSRIs, rhubarb, red clover, licorice, kudzu, black cohosh, ginseng or other similar roots, etc.)

Sponsors & Collaborators

• NeuTherapeutics: lead
• University of Arizona: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fei Yin, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Gerson D Hernandez, MD, MPH

  University of Arizona

  STUDY DIRECTOR

Central Study Contacts

Claudia M Lopez, BSc

CONTACT

520-626-6276; claudiml@arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, placebo-controlled, parallel group design with open-label extension.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 2, 2024
• Study Start: November 17, 2023
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

US (1)