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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights
Study Summary
This trial studies the effects of a natural supplement on brain metabolism in menopausal women. It will use scans to measure results.
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.Check my eligibility
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.See study design
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 belowSelect...
I can take pills and will follow the PhytoSERM treatment plan.
Select...
I am between 45 and 60 years old.
Select...
I experience 7 or more hot flashes daily.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Standardized uptake value ratio (SUVR) by 18F-FDG PET
Secondary outcome measures
Auditory Verbal Learning Test
Beck Depression Inventory - II
Hot flash Frequency Composite
+11 moreOther outcome measures
Cerebral blood perfusion
Diabetic biomarker: Hemoglobin A1C (HbA1c)
Fractional Anisotropy
+8 moreTrial 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.
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Who is running the clinical trial?
University of ArizonaLead Sponsor
515 Previous Clinical Trials
148,614 Total Patients Enrolled
1 Trials studying Menopause
132 Patients Enrolled for Menopause
Roberta BrintonLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,785 Total Patients Enrolled
16 Trials studying Menopause
3,113 Patients Enrolled for Menopause
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lab test results need to be normal, or if they're not, the doctor will decide if it's not a big problem.I have never had epilepsy, severe head injuries, or major psychiatric disorders.I am not pregnant and will use effective birth control during the study.I do not have any significant health issues or abnormal lab results.I have not had blood clots, heart attacks, or strokes.You are not able to have PET scans.You cannot have an MRI scan.I have trouble seeing or hearing that makes it hard for me to take tests.I am willing and able to follow all study rules and attend all appointments.I can take pills and will follow the PhytoSERM treatment plan.I have not used estrogen or progestin compounds in the last 8 weeks.You currently smoke or have had issues with drinking too much alcohol in the past.I am a woman who has not had a menstrual period for at least 60 days but no more than 4 years.You have trouble with your memory or thinking, as shown by a test score below 27.You are allergic to isoflavones or soy-based products.I am fluent in either English or Spanish.My medications have not changed in the last 4 weeks.I have or am at risk for hormone-related cancer.You are allergic to soy-based products or certain over-the-counter products, or you have a strong reaction to estrogen or progestin.I am between 45 and 60 years old.I experience 7 or more hot flashes daily.I haven't used any treatments for menopause or memory problems in the last 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: PhytoSERM group
- Group 2: Placebo group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical study open to senior citizens?
"This clinical trial only permits individuals aged 45 to 60 years old, in compliance with the eligibility criteria."
Answered by AI
Are there vacancies available for participants in this clinical trial?
"According to the clinicaltrials.gov database, this particular trial is no longer recruiting patients. It was first posted on September 15th 2023 and last updated August 3rd of that same year. Nonetheless, there are still 224 other studies actively seeking participants at present."
Answered by AI
What adverse effects might patients encounter when using products in the PhytoSERM category?
"Our assessment of PhytoSERM's safety was considered to be a 2, since the Phase 2 trial provided some assurance surrounding its security but not much in terms of efficacy."
Answered by AI
Is it possible for me to partake in this research endeavor?
"This trial is currently looking for 100 participants between the ages of 45 and 60 who are experiencing menopause. Furthermore, these patients must fulfill a number of criteria in order to be suitable: they must have completed their last menstrual period at least 60 days ago but no later than 4 years ago; present with hot flashes 7 times daily or more; demonstrate general good health upon medical examination; possess clinical laboratory values that align with norms or that do not negatively influence participation if deemed abnormal by investigator; lack any form of medical contraindication which would bar them from taking part in the study; remain on stable medication for four weeks prior to baseline"
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
The Alzheimer's Prevention Program / Weill Cornell Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I SUFFER with hot flashes and need help.
PatientReceived 2+ prior treatments
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