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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG033288 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to evaluate the safety and efficacy of a soy based dietary supplement (phytoSERM) for hot flashes and age associated memory loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PhytoSERM 50 mg tablet | Experimental | Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks |
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| PhytoSERM 100 mg tablet | Experimental | Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks |
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| Placebo tablet | Placebo Comparator | Dietary supplement: placebo tablet to be taken once per day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PhytoSERM tablet | Dietary Supplement |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability | as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance | 12 weeks |
| efficacy | change from baseline in neuropsychological (cognitive, functional) test results | 12 weeks |
| efficacy | change from baseline in vasomotor symptoms | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lon S Schneider, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Keck School of Medicine | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30889096 | Derived | Schneider LS, Hernandez G, Zhao L, Franke AA, Chen YL, Pawluczyk S, Mack WJ, Brinton RD. Safety and feasibility of estrogen receptor-beta targeted phytoSERM formulation for menopausal symptoms: phase 1b/2a randomized clinical trial. Menopause. 2019 Aug;26(8):874-884. doi: 10.1097/GME.0000000000001325. | |
| 28926513 | Derived | Hernandez G, Zhao L, Franke AA, Chen YL, Mack WJ, Brinton RD, Schneider LS. Pharmacokinetics and safety profile of single-dose administration of an estrogen receptor beta-selective phytoestrogenic (phytoSERM) formulation in perimenopausal and postmenopausal women. Menopause. 2018 Feb;25(2):191-196. doi: 10.1097/GME.0000000000000984. |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| Dietary Supplement |
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| D009422 | Nervous System Diseases |