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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Federal University of São Paulo.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00925639
First received: June 19, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 19, 2009
June 19, 2009
August 2009
January 2010   (final data collection date for primary outcome measure)
Concentration of serum DDimer [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause
Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Menopause
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
84
August 2010
January 2010   (final data collection date for primary outcome measure)

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
Female
45 Years to 65 Years
Yes
Contact: Regiane HB Rabelo, MD 5511-72307128 gianehelena@ig.com.br
Contact: Teresa R Embiruçu, MD 5511-74513521 embirucu2@yahoo.com.br
Brazil
 
NCT00925639
CEP/UNIFESP 0728/08
No
Regiane Helena Barros Rabelo, Departamento de Ginecologia da Universidade Federal de São Paulo
Federal University of São Paulo
Not Provided
Study Chair: Mauro A Aidar, M.D., PhD. Universidade Federal de São Paulo
Federal University of São Paulo
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP