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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Federal University of São Paulo.
Recruitment status was:  Not yet recruiting
Information provided by:
Federal University of São Paulo Identifier:
First received: June 19, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
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.

Condition Intervention Phase
Drug: Isoflavone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause

Resource links provided by NLM:

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Concentration of serum DDimer [ Time Frame: 3 months ]

Estimated Enrollment: 84
Study Start Date: August 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Isoflavone
Patients will receive daily doses of 150 mg of concentrated extract of soy per os
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.
Placebo Comparator: Control
Patients will receive daily placebo pills
Drug: Placebo
Starch pill


Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00925639

Contact: Regiane HB Rabelo, MD 5511-72307128
Contact: Teresa R Embiruçu, MD 5511-74513521

Ambulatório de Ginecologia Endócrina Recruiting
São Paulo, Brazil, 04039-060
Contact: Maria Cecília Santos, Nurse    5511-55496174   
Principal Investigator: Regiane HB Rabelo, M.D.         
Sponsors and Collaborators
Federal University of São Paulo
Study Chair: Mauro A Aidar, M.D., PhD. Universidade Federal de São Paulo
  More Information

Additional Information:
Responsible Party: Regiane Helena Barros Rabelo, Departamento de Ginecologia da Universidade Federal de São Paulo Identifier: NCT00925639     History of Changes
Other Study ID Numbers: CEP/UNIFESP 0728/08
Study First Received: June 19, 2009
Last Updated: June 19, 2009

Keywords provided by Federal University of São Paulo:
hypercoagulation processed this record on May 25, 2017