Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause
- Registration Number
- NCT00925639
- Lead Sponsor
- Federal University of São Paulo
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 84
- > 1 year of amenorrhea
- 45 to 65 years old
- without hormone reposition treatment or herbal medications in the 6 months preceding the research
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Placebo Patients will receive daily placebo pills Isoflavone Isoflavone Patients will receive daily doses of 150 mg of concentrated extract of soy per os
- Primary Outcome Measures
Name Time Method Concentration of serum DDimer 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ambulatório de Ginecologia Endócrina
🇧🇷São Paulo, Brazil