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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Isoflavone

Patients will receive daily doses of 150 mg of concentrated extract of soy per os

Group Type EXPERIMENTAL

Isoflavone

Intervention Type DRUG

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.

Control

Patients will receive daily placebo pills

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Starch pill

Interventions

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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.

Intervention Type DRUG

Placebo

Starch pill

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes