Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause
Phase 3
45 Years
65 Years
45 Years
65 Years
Not Enrolling
Female
Menopause
Female
Menopause
Trial Information
Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Concentration of serum DDimer
Outcome Time Frame:
3 months
Safety Issue:
Yes
Principal Investigator
Mauro A Aidar, M.D., PhD.
Investigator Role:
Study Chair
Investigator Affiliation:
Universidade Federal de São Paulo
Authority:
Brazil: National Committee of Ethics in Research
Study ID:
CEP/UNIFESP 0728/08
NCT ID:
NCT00925639
Start Date:
August 2009
Completion Date:
August 2010
Related Keywords:
- Menopause
- phytoestrogen
- coagulation
- menopause
- ddimer
- antithrombin
- hypercoagulation
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