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Phytoestrogen Supplement

PhytoSERM for Hot Flashes (HF-Relief Trial)

Phase 2

Recruiting

Led By Fei Yin, PhD

Research Sponsored by NeuTherapeutics

Eligibility Criteria Checklist

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

Must have

Age 45-60 years

Peri- or postmenopausal women, defined by specific criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4, 8, 12, 18, 24 and 28.

Awards & highlights

HF-Relief Trial Summary

This trial is testing the effects of a supplement called PhytoSERM on menopausal symptoms in women. Participants will either take PhytoSERM pills or a placebo for 12 weeks. After

Who is the study for?

This trial is for peri- and postmenopausal women experiencing hot flashes. Participants will be randomly assigned to receive either the PhytoSERM supplement or a placebo daily for 12 weeks, with those initially on placebo switching to PhytoSERM afterwards.Check my eligibility

What is being tested?

The study tests if PhytoSERM, a phytoestrogenic supplement, can alleviate menopausal symptoms like hot flashes and positively affect blood biomarkers related to brain health in menopausal women.See study design

What are the potential side effects?

Potential side effects of PhytoSERM are not detailed here but may include reactions similar to other estrogenic supplements such as digestive issues, mood changes, or headaches.

HF-Relief Trial Eligibility Criteria

Inclusion Criteria

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

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I am between 45 and 60 years old.

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I am a woman who has gone through menopause.

Select...

I experience 7 or more hot flashes daily.

HF-Relief Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4, 8, 12, 18, 24 and 28.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4, 8, 12, 18, 24 and 28.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, 8, 12, 18, 24 and 28. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hot Flash Composite score

Secondary outcome measures

Body Mass Index (BMI)

Bone Mineral Content (BMC)

Bone Mineral Density (BMD)

+9 more

Other outcome measures

Aß40:Aß42 ratio

Cholesterol levels

Digital hot flash frequency

+6 more

HF-Relief Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PhytoSERMExperimental Treatment1 Intervention

Active intervention group

Group II: Placebo groupPlacebo Group1 Intervention

Control group

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArizonaOTHER

515 Previous Clinical Trials

148,582 Total Patients Enrolled

NeuTherapeuticsLead Sponsor

Fei Yin, PhDPrincipal InvestigatorUniversity of Arizona

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"Indeed, as per the information available on clinicaltrials.gov, this research investigation is currently seeking eligible participants. The initial posting of the study took place on November 17th, 2023 and it was last revised on December 15th, 2023."

Answered by AI

Which individuals are eligible to take part in this research study?

"Eligible participants for this clinical trial should be experiencing menopause and fall within the age range of 45 to 60. The study aims to recruit a total of 132 individuals."

Answered by AI

Are individuals who are 55 years or older eligible to participate in this clinical trial?

"To participate in this trial, patients must be within the age range of 45 to 60. It is worth noting that there are separate clinical trials available for individuals under the age of 18 (consisting of 4 trials) and those aged over 65 (comprising of 43 trials)."

Answered by AI

Has the FDA granted approval for PhytoSERM to be used as a medical treatment?

"Based on the Power team's evaluation, PhytoSERM's safety is rated as a 2. This rating reflects that there is limited data supporting its safety in this Phase 2 trial, while no evidence of efficacy has been established yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health

2023. "PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06186531.

All > Hot Flashes > Menopause