MenopausePhase 2HF-ReliefNCT06186531
PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health
A Phase 2 study testing PhytoSERM in people with Menopause and Hot Flashes, run by NeuTherapeutics at 1 site in United States.
Trial summary
This is a proof-of-concept phase 2 clinical trial to investigate the effect of the phytoestrogenic supplement PhytoSERM on vasomotor symptoms and other symptoms associated with the menopausal transition, and on blood-based biomarkers in peri- and postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause, Hot Flashes
- What is being tested?
- PhytoSERM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2023to 15 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Peri- or postmenopausal women, defined by any of the following:
- Last menstrual period (LMP) completed ≥ 60 days and ≤ 8 years, per the Stages of Reproductive Aging Workshop (STRAW) criteria.
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Arizona
Tucson, Arizona, 85724
Claudia M Lopez, BSc, 520-626-6276, claudiml@arizona.edu
About this study
Official title: PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial
This is a proof-of-concept phase 2 clinical trial to investigate the effect of the phytoestrogenic supplement PhytoSERM on vasomotor symptoms and other symptoms associated with the menopausal transition, and on blood-based biomarkers in peri- and postmenopausal women.
After the screening period, participants will be randomized to PhytoSERM 50 mg pills (administered orally, once per day) or matching placebo, 1:1 allocation, for a period of 12 weeks. After 12 weeks, all participants in the placebo group will be crossed-over to receive PhytoSERM pills for the remainder of the study (open-label phase).
Read the detailed description
This is a double-blinded, randomized, placebo-controlled, parallel designed, proof-of-concept phase 2 clinical trial to determine effect of PhytoSERM on vasomotor symptoms and other symptoms associated with the menopausal transition. PhytoSERM or placebo pills will be administered orally once a day over 24 weeks. Safety and tolerability will also be assessed over the duration of the study.
A total of 132 peri- or postmenopausal women aged 45-60 years and who are experiencing hot flashes will be enrolled in this trial. To determine eligibility, all participants will undergo cognitive assessment, physical assessment, ECG, clinical/safety laboratory assessment, and interviews. After a 2-week screening period, participants will be randomized to study intervention (PhytoSERM 50mg administered orally, once per day) or matching placebo, in a 1:1 allocation. After 12 weeks, participants in the placebo group will be crossed-over to PhytoSERM 50 mg for the remaining 12 weeks (open-label extension period). Hot flashes will be measured both objectively and subjectively. Objective data will be skin conductance levels collected via a wearable device that enables real-time physiological data acquisition, including activity and sleep data. Study participants will be asked to complete a total of 8 study visits. Study visits will occur at 4-week intervals after the baseline, except for visits # 6 and 7 (open-label period) which will occur at 6-week intervals after visit # 5 (final outcomes assessments visit). Visits 1, 2, 5 and 7 will last approximately 2-4 hours; visits 3, 4, 6 and 8 will last approximately 45 minutes.
All participants will be enrolled at a single site, at the University of Arizona (UA) Clinical \& Translational Sciences Research Center (CATS).
- Conditions
- Menopause, Hot Flashes
- Being tested
- PhytoSERM, Placebo
- Keywords
- Phytoestrogen supplement, Menopause, Hot flashes, Cognition
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhytoSERMDietary supplement
PhytoSERM, a formulated dietary supplement, will be an ovalized tablet measuring 8.51 mm x 15.49 mm. Each pill will contain a white PEG coating and an equal mixture of, daidzein, genistein, and S-equol.
PlaceboDrug
Placebo product is of identical shape, size and color with a white PEG coating but without S-equol, daidzein and genistein.
| Study group | Role | What they receive |
|---|---|---|
| PhytoSERM | Experimental | Active intervention group Receives: Dietary Supplement: PhytoSERM |
| Placebo group | Placebo comparator | Control group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot Flash Composite score
Composite score comprised by hot flash frequency and severity (sum of weekly hot flashes weighted by severity: mild, moderate, severe). Higher score indicates a bad outcome. No minimum or maximum values.
Measured: Daily from baseline to week 24
Secondary outcomes (12)
Trail Making Test score
Test that involves visual scanning and working memory. Score is the amount of seconds taken to complete the test; the greater the time the worse the score.
Measured: Baseline, week 4, 8, 12 and 24.
NIH Toolbox List Sorting Working Memory Test score
An assessment of working memory administered on an iPad. Scores range from 0 to 26, with higher being better.
Measured: Baseline, week 4, 8, 12 and 24.
NIH Toolbox Picture Sequence Memory Test
An assessment of episodic memory administered on an iPad. The participants are asked to recall the sequence of pictures demonstrated over two learning trials; sequence length varies from 6-18 pictures. Participants are given credit for each adjacent pair of pictures they correctly place up to the maximum value for the sequence, which is one less than the sequence length. Range is 0-17.
Measured: Baseline, week 4, 8, 12 and 24.
NIH Toolbox Auditory Verbal Learning Test
An assessment of immediate memory and verbal learning administered on an iPad.Possible range is 0-45 words, with higher scores representing better performance.
Measured: Baseline, week 4, 8, 12 and 24.
NIH Toolbox Oral Symbol Digit Test
An assessment of processing speed administered on an iPad. Scored as the number of items answered correctly in 120 seconds (possible range is 0-144).
Measured: Baseline, week 4, 8, 12 and 24.
Pittsburgh Sleep Quality Index (PSQI)
Instrument used to measure the quality patterns of sleep in the older adult. A global sum of "5" or greater indicates a "poor" sleeper.
Measured: Baseline, week 4, 8, 12, 18, 24 and 28.
Menopause Rating Scale score
A a health-related quality of life scale measuring the impact of menopausal symptoms. The total score of the MRS ranges between 0 (asymptomatic) and 44 (highest degree of complaints).
Measured: At screening, weeks 12, 24 and 28.
Bone Mineral Density (BMD)
BMD in g/cm2 will be measured with a Dual-energy X-ray absorptiometry (DXA) scan. Expected range is 0.5-1.5 g/cm2, with higher being better.
Measured: Baseline, week 12 and 24
Bone Mineral Content (BMC)
BMC in grams will be measured with a Dual-energy X-ray absorptiometry (DXA) scan. Expected range is 2,000 - 3,500 g, with higher being better.
Measured: Baseline, week 12 and 24
Body Mass Index (BMI)
BMI will be measured with a Dual-energy X-ray absorptiometry (DXA) scan. Range is 10-45.
Measured: Baseline, week 12 and 24
Total Fat Mass (TFM)
TFM in grams will be measured with a Dual-energy X-ray absorptiometry (DXA) scan.
Measured: Baseline, week 12 and 24
Total Lean Mass (TLM)
TLM in grams will be measured with a Dual-energy X-ray absorptiometry (DXA) scan.
Measured: Baseline, week 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start17 Nov 2023
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, placebo-controlled, parallel group design with open-label extension.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuTherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Arizona
- Responsible party
- Sponsor
- Investigators
- Fei Yin, PhD, Principal investigator, University of ArizonaGerson D Hernandez, MD, MPH, Study director, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186531
- Sponsor's protocol ID
- Phyto-HF-2022-01
- Acronym
- HF-Relief
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT06186531
- Acronym / sponsor ID
- HF-Relief / Phyto-HF-2022-01
- Conditions
- Menopause, Hot Flashes
- Keywords
- Phytoestrogen supplement, Menopause, Hot flashes, Cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- NeuTherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- University of Arizona
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a proof-of-concept phase 2 clinical trial to investigate the effect of the phytoestrogenic supplement PhytoSERM on vasomotor symptoms and other symptoms associated with the menopausal transition, and on blood-based biomarkers in peri- and postmenopausal women.
After the screening period, participants will be randomized to PhytoSERM 50 mg pills (administered orally, once per day) or matching placebo, 1:1 allocation, for a period of 12 weeks. After 12 weeks, all participants in the placebo group will be crossed-over to receive PhytoSERM pills for the remainder of the study (open-label phase).
Detailed description
This is a double-blinded, randomized, placebo-controlled, parallel designed, proof-of-concept phase 2 clinical trial to determine effect of PhytoSERM on vasomotor symptoms and other symptoms associated with the menopausal transition. PhytoSERM or placebo pills will be administered orally once a day over 24 weeks. Safety and tolerability will also be assessed over the duration of the study.
A total of 132 peri- or postmenopausal women aged 45-60 years and who are experiencing hot flashes will be enrolled in this trial. To determine eligibility, all participants will undergo cognitive assessment, physical assessment, ECG, clinical/safety laboratory assessment, and interviews. After a 2-week screening period, participants will be randomized to study intervention (PhytoSERM 50mg administered orally, once per day) or matching placebo, in a 1:1 allocation. After 12 weeks, participants in the placebo group will be crossed-over to PhytoSERM 50 mg for the remaining 12 weeks (open-label extension period). Hot flashes will be measured both objectively and subjectively. Objective data will be skin conductance levels collected via a wearable device that enables real-time physiological data acquisition, including activity and sleep data. Study participants will be asked to complete a total of 8 study visits. Study visits will occur at 4-week intervals after the baseline, except for visits # 6 and 7 (open-label period) which will occur at 6-week intervals after visit # 5 (final outcomes assessments visit). Visits 1, 2, 5 and 7 will last approximately 2-4 hours; visits 3, 4, 6 and 8 will last approximately 45 minutes.
All participants will be enrolled at a single site, at the University of Arizona (UA) Clinical \& Translational Sciences Research Center (CATS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled, parallel group design with open-label extension.
| Arm | Type | Receives |
|---|---|---|
| PhytoSERM | Experimental | Dietary Supplement: PhytoSERMActive intervention group |
| Placebo group | Placebo comparator | Drug: PlaceboControl group |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Peri- or postmenopausal women, defined by any of the following:
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhytoSERMPhytoSERM, a formulated dietary supplement, will be an ovalized tablet measuring 8.51 mm x 15.49 mm. Each pill will contain a white PEG coating and an equal mixture of, daidzein, genistein, and S-equol. | Dietary supplement | PhytoSERM |
| PlaceboPlacebo product is of identical shape, size and color with a white PEG coating but without S-equol, daidzein and genistein. | Drug | Placebo group |
Primary outcome
Hot Flash Composite score
Time frame: Daily from baseline to week 24
Composite score comprised by hot flash frequency and severity (sum of weekly hot flashes weighted by severity: mild, moderate, severe). Higher score indicates a bad outcome. No minimum or maximum values.
12 secondary outcomes
Trail Making Test score
Time frame: Baseline, week 4, 8, 12 and 24.
NIH Toolbox List Sorting Working Memory Test score
Time frame: Baseline, week 4, 8, 12 and 24.
NIH Toolbox Picture Sequence Memory Test
Time frame: Baseline, week 4, 8, 12 and 24.
NIH Toolbox Auditory Verbal Learning Test
Time frame: Baseline, week 4, 8, 12 and 24.
NIH Toolbox Oral Symbol Digit Test
Time frame: Baseline, week 4, 8, 12 and 24.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, week 4, 8, 12, 18, 24 and 28.
Menopause Rating Scale score
Time frame: At screening, weeks 12, 24 and 28.
Bone Mineral Density (BMD)
Time frame: Baseline, week 12 and 24
Bone Mineral Content (BMC)
Time frame: Baseline, week 12 and 24
Body Mass Index (BMI)
Time frame: Baseline, week 12 and 24
Total Fat Mass (TFM)
Time frame: Baseline, week 12 and 24
Total Lean Mass (TLM)
Time frame: Baseline, week 12 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Yin, PhD principal investigator
University of Arizona
Gerson D Hernandez, MD, MPH study director
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PhytoSERM in people with Menopause and Hot Flashes, run by NeuTherapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia M Lopez, BSc (520-626-6276, claudiml@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot Flash Composite score (time frame: Daily from baseline to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.