- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00925639
Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause
June 19, 2009 updated by: Federal University of São Paulo
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
84
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Regiane HB Rabelo, MD
- Phone Number: 5511-72307128
- Email: gianehelena@ig.com.br
Study Contact Backup
- Name: Teresa R Embiruçu, MD
- Phone Number: 5511-74513521
- Email: embirucu2@yahoo.com.br
Study Locations
-
-
-
São Paulo, Brazil, 04039-060
- Ambulatório de Ginecologia Endócrina
-
Principal Investigator:
- Regiane HB Rabelo, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Isoflavone
Patients will receive daily doses of 150 mg of concentrated extract of soy per os
|
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
|
Starch pill
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Concentration of serum DDimer
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mauro A Aidar, M.D., PhD., Universidade Federal de Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Anticipated)
January 1, 2010
Study Completion (Anticipated)
August 1, 2010
Study Registration Dates
First Submitted
June 19, 2009
First Submitted That Met QC Criteria
June 19, 2009
First Posted (Estimate)
June 22, 2009
Study Record Updates
Last Update Posted (Estimate)
June 22, 2009
Last Update Submitted That Met QC Criteria
June 19, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- CEP/UNIFESP 0728/08
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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