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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
Must not have
Chronic use of most benzodiazepines
Known or suspected estrogen-dependent neoplasia, active neoplastic disease, history of breast cancer, and endometrial hyperplasia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, 8, 12, 18, 24 and 28.
Awards & highlights

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.
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.
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.

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.
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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 regularly use benzodiazepines.
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I have or might have cancer that grows with estrogen, including breast cancer.
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I have no history of severe brain injuries, epilepsy, or major psychiatric disorders.
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I use supplements that contain isoflavones.
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I have not had blood clots, heart attacks, strokes, or similar conditions.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hot Flash Composite score
Secondary study objectives
Body Mass Index (BMI)
Bone Mineral Content (BMC)
Bone Mineral Density (BMD)
+9 more
Other study objectives
Aß40:Aß42 ratio
Cholesterol levels
Digital hot flash frequency
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PhytoSERMExperimental Treatment1 Intervention
Active intervention group
Group II: Placebo groupPlacebo Group1 Intervention
Control group

Find a Location

Who is running the clinical trial?

University of ArizonaOTHER
525 Previous Clinical Trials
155,116 Total Patients Enrolled
NeuTherapeuticsLead Sponsor
Fei Yin, PhDPrincipal InvestigatorUniversity of Arizona
~12 spots leftby Nov 2024
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