PhytoSERM for managing menopausal hot flashes and supporting brain health

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

This study is testing if a supplement called PhytoSERM can help reduce hot flashes and improve brain health in women going through menopause.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 45 Years to 60 Years
• Sex: Female
• Sponsor: NeuTherapeutics (Industry-sponsored)
• Locations: 1 site (Tucson, Arizona)
• Trial ID: NCT06186531 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial investigates the effects of the phytoestrogen supplement PhytoSERM on hot flashes and other menopausal symptoms in peri- and postmenopausal women. Participants will be randomly assigned to receive either PhytoSERM or a placebo for 12 weeks, followed by an open-label phase where all participants will receive PhytoSERM for an additional 12 weeks. The study will assess both subjective and objective measures of hot flashes, including physiological data collected via a wearable device. Safety and tolerability will also be monitored throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are peri- or postmenopausal women aged 45-60 experiencing at least 7 hot flashes per day.

Not a fit: Patients who are not peri- or postmenopausal or those with significant medical contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective non-hormonal treatment option for managing menopausal symptoms and improving cognitive health.

How similar studies have performed: Other studies have shown promise with phytoestrogen supplements for menopausal symptoms, but this specific approach is still being evaluated.

Eligibility criteria

Inclusion Criteria:

* Peri- or postmenopausal women, defined by any of the following:

  1. Last menstrual period (LMP) completed ≥ 60 days and ≤ 8 years, per the Stages of Reproductive Aging Workshop (STRAW) criteria.
  2. 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.

Exclusion Criteria:

* 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.)
* Evidence of any significant clinical disorder or laboratory finding, including clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality.
* Known allergy to soy-derived products/ proteins or branded over the counter products; hypersensitivity to estrogens or progestins.

Where this trial is running

Tucson, Arizona

• University of Arizona — Tucson, Arizona, United States (Recruiting)

Study contacts

• Principal investigator: Fei Yin, PhD — University of Arizona
• Study coordinator: Claudia M Lopez, BSc

Conditions Menopause; Hot Flashes; Phytoestrogen supplement; Hot flashes; Cognition