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临床试验/NCT00925639
NCT00925639Unknown3 期

Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Patients will receive daily doses of 150 mg of concentrated extract of soy per os

干预措施: Isoflavone (Drug)

Control

Placebo Comparator

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

研究者

发起方
Federal University of São Paulo
申办方类型
Other

研究点 (1)

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