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

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

Tracking Information

First Received Date ^ICMJE

June 19, 2009

Last Updated Date

June 19, 2009

Start Date ^ICMJE

August 2009

Estimated Primary Completion Date

January 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 Blind (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

Estimated 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)

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

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

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