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

Tracking Information
First Submitted Date ICMJE	June 19, 2009
First Posted Date ICMJE	June 22, 2009
Last Update Posted Date	June 22, 2009
Study Start Date ICMJE	August 2009
Estimated Primary Completion Date	January 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 19, 2009)	Concentration of serum DDimer [ Time Frame: 3 months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause
Official Title ICMJE	Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Menopause
Intervention ICMJE	Drug: Isoflavone 150 mg of concentrated extract of soy containing 60 mg of isoflavone comprising 40 mg of genistein, 14,55 mg of daidizein, 3,02 mg of daidzine, 1,14 mg of glicitine, 0,91 mg genistine and 0,38 mg of glicetein.; Drug: Placebo Starch pill
Study Arms	Experimental: Isoflavone Patients will receive daily doses of 150 mg of concentrated extract of soy per os Intervention: Drug: Isoflavone; Placebo Comparator: Control Patients will receive daily placebo pills Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: June 19, 2009)	84
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	August 2010
Estimated Primary Completion Date	January 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Female
Ages	45 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Brazil
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00925639
Other Study ID Numbers ICMJE	CEP/UNIFESP 0728/08
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Regiane Helena Barros Rabelo, Departamento de Ginecologia da Universidade Federal de São Paulo
Study Sponsor ICMJE	Federal University of São Paulo
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Mauro A Aidar, M.D., PhD. Universidade Federal de São Paulo
PRS Account	Federal University of São Paulo
Verification Date	June 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP