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
  Purpose

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
Menopause
Drug: Isoflavone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925639

Contacts
Contact: Regiane HB Rabelo, MD 5511-72307128 gianehelena@ig.com.br
Contact: Teresa R Embiruçu, MD 5511-74513521 embirucu2@yahoo.com.br

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

Additional Information:
No publications provided

Responsible Party: Regiane Helena Barros Rabelo, Departamento de Ginecologia da Universidade Federal de São Paulo
ClinicalTrials.gov Identifier: NCT00925639     History of Changes
Other Study ID Numbers: CEP/UNIFESP 0728/08
Study First Received: June 19, 2009
Last Updated: June 19, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
phytoestrogen
coagulation
menopause
ddimer
antithrombin
hypercoagulation

ClinicalTrials.gov processed this record on August 18, 2014