Overview

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

Status:
Unknown status
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Federal University of São Paulo
Criteria
Inclusion Criteria:

- > 1 year of amenorrhea

- 45 to 65 years old

- without hormone reposition treatment or herbal medications in the 6 months preceding
the research

Exclusion Criteria:

- 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