Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- safety and tolerability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •post-menopausal women
- •ages 45 - 60 (inclusive)
- •must have a vasomotor symptom (e.g., hot flash) and a memory complaint
排除标准
- •history of clinically significant stroke
- •current evidence or history in past 2 years of epilepsy, seizure, focal brain lesion, head injury with loss of consciousness or any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
- •Known allergy to soy derived products; hypersensitivity to estrogens or progestins
研究组 & 干预措施
PhytoSERM 50 mg tablet
Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
干预措施: PhytoSERM tablet (Dietary Supplement)
PhytoSERM 100 mg tablet
Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks
干预措施: PhytoSERM tablet (Dietary Supplement)
Placebo tablet
Dietary supplement: placebo tablet to be taken once per day for 12 weeks
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
safety and tolerability
时间窗: 12 weeks
as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance
efficacy
时间窗: 12 weeks
change from baseline in neuropsychological (cognitive, functional) test results
次要结局
未报告次要终点
研究者
Lon Schneider
Professor
University of Southern California