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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
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.
Placebo product is of identical shape, size and color with a white PEG coating but without S-equol, daidzein and genistein.
University of Arizona
Tucson, Arizona, United States
RECRUITINGHot 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.
Time frame: Daily from baseline to week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 12 and 24
Total Fat Mass (TFM)
TFM in grams will be measured with a Dual-energy X-ray absorptiometry (DXA) scan.
Time frame: Baseline, week 12 and 24
Total Lean Mass (TLM)
TLM in grams will be measured with a Dual-energy X-ray absorptiometry (DXA) scan.
Time frame: Baseline, week 12 and 24