What side effects are associated with this type of intervention?

Phytoestrogenic supplements, such as those containing soy isoflavones, are generally considered safe but can have side effects including gastrointestinal issues like bloating and constipation. Some studies suggest a potential risk of endometrial hyperplasia with long-term use. Hormone replacement therapy (HRT), another common treatment, can cause side effects such as breast tenderness, headaches, mood swings, and an increased risk of blood clots and certain cancers. Non-hormonal treatments like SSRIs (e.g., paroxetine) and SNRIs (e.g., venlafaxine) can also be used, with side effects including nausea, dizziness, and sexual dysfunction.

What prior FDA approvals exist?

The FDA has approved several treatments for menopausal symptoms, primarily focusing on hormone replacement therapies (HRT) such as 17-beta estradiol and conjugated equine estrogens (CEE). These treatments help alleviate hot flashes, night sweats, and other menopausal symptoms by supplementing estrogen levels. While phytoestrogens like those in PhytoSERM are being studied for their potential benefits in modulating estrogen receptors and influencing brain glucose metabolism, they are not yet FDA-approved for menopause treatment. Current FDA-approved options mainly include synthetic hormones rather than plant-based phytoestrogens.

What other types of research exist?

Promising alternatives to PhytoSERM for menopause patients include hormone replacement therapy (HRT) with estrogen and progestin, which has been shown to improve cognitive function and mood. Additionally, soy isoflavones, particularly genistein, have demonstrated potential benefits for hot flashes and bone health. Melatonin has also been studied for its potential to support brain metabolism and overall health in cancer patients. These alternatives should be discussed with a healthcare provider to tailor treatment to individual needs.

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Phytoestrogenic Supplement

PhytoSERM for Menopause-related Cognitive Impairment

Phase 2

Recruiting

Led By Roberta D Brinton, PhD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to take oral medication and be willing to adhere to the PhytoSERM regimen

Age 45-60 years

Must not have

Thrombophlebitis, thrombosis, thromboembolic disorders, myocardial infarction, ischemic heart disease, cerebrovascular accident, stroke, transient ischemic attack (TIA)

History of epilepsy, focal brain lesion, head injury with loss of consciousness or Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 weeks

Summary

This trial tests PhytoSERM, a plant-based supplement that mimics estrogen, in peri- and postmenopausal women. The goal is to see if it helps the brain use glucose better, potentially improving brain function and reducing menopausal symptoms. Participants will take the supplement for several months, with brain scans before and after to measure effects. PhytoSERM is a formulation of genistein, daidzein, and S-equol that may enhance neuron function and estrogenic mechanisms in the brain.

Who is the study for?

This trial is for peri- or postmenopausal women aged 45-60, experiencing hot flashes at least 7 times a day. Participants must be in good health, fluent in English/Spanish, and willing to follow the study procedures. They can't join if they've had recent cardiovascular issues, are pregnant, have used hormone treatments recently, or have certain cognitive impairments.

What is being tested?

The trial tests PhytoSERM's safety and its effect on brain metabolism compared to a placebo in menopausal women. It measures changes using an imaging technique called 18F-FDG-PET that tracks glucose metabolism in the brain.

What are the potential side effects?

Potential side effects of PhytoSERM may include reactions similar to those from soy products due to its phytoestrogen content. However, specific side effects will be monitored as this is a safety and efficacy study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take pills and will follow the PhytoSERM treatment plan.

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I am between 45 and 60 years old.

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I experience 7 or more hot flashes daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had blood clots, heart attacks, or strokes.

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I have never had epilepsy, severe head injuries, or major psychiatric disorders.

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I have trouble seeing or hearing that makes it hard for me to take tests.

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I have or am at risk for hormone-related cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Standardized uptake value ratio (SUVR) by 18F-FDG PET

Secondary study objectives

Auditory Verbal Learning Test

Beck Depression Inventory - II

Hot flash Frequency Composite

+11 more

Other study objectives

Cerebral blood perfusion

Diabetic biomarker: Hemoglobin A1C (HbA1c)

Fractional Anisotropy

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PhytoSERM groupExperimental Treatment1 Intervention

PhytoSERM 50mg tablet composed of the phytoestrogens daidzein, genistein and S-equol, administered orally every day for 24 weeks.

Group II: Placebo groupPlacebo Group1 Intervention

Placebo product with identical shape, size and color with absence of daidzein, genistein, and S-equol. Administered orally every day for 24 weeks.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Phytoestrogens, such as those in the PhytoSERM supplement, act by binding to estrogen receptors, mimicking the effects of estrogen. This can help alleviate menopausal symptoms like hot flashes and cognitive decline. Additionally, phytoestrogens may influence glucose metabolism in the brain, potentially offering neuroprotective benefits. Understanding these mechanisms is crucial for menopause patients as it provides insight into how these treatments can help manage symptoms and improve quality of life.