Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Concentration of serum DDimer
研究概览
简要总结
Hypoestrogenism, common in menopause, is responsible for systemic and metabolic changes affecting women's wellness, favoring hot flashes, urogenital atrophy and bone mass loss. Hormone reposition therapy (HRT) with estrogen or estrogen associated to progesterone is administered to minimize these effects. Meanwhile, the beneficial effects of HRT are known, there is still concern about its adverse effects such as thromboembolic and cardiovascular effects, increased risk of breast and endometrial cancer. Thus, there is an increasing interest in the development of phytohormonal HRT. The aim of the investigators' study is to evaluate the effects of concentrated extract of soy on hypercoagulation markers in menopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •> 1 year of amenorrhea
- •45 to 65 years old
- •without hormone reposition treatment or herbal medications in the 6 months preceding the research
排除标准
- •history of thromboembolism
- •history of cardiovascular disease
- •presence of estrogen dependent neoplasia
- •presence of abnormal genital bleeding
- •uncontrolled metabolic diseases
- •smoking or drinking habits
- •use of anticoagulants or acetyl salicylic acid
研究组 & 干预措施
Isoflavone
Patients will receive daily doses of 150 mg of concentrated extract of soy per os
干预措施: Isoflavone (Drug)
Control
Patients will receive daily placebo pills
干预措施: Placebo (Drug)
结局指标
主要结局
Concentration of serum DDimer
时间窗: 3 months
次要结局
未报告次要终点
