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

NCT00925639 — Phase 3, Unknown, 84 participants, Federal University of São Paulo

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Registry	NCT00925639
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	84 (Estimated)
Sponsor	Federal University of São Paulo (Other)
Conditions	Menopause
Interventions	Isoflavone, Placebo (Drug)
Dates	start 2009-08-01, primary completion 2010-01-01 (estimated), completion 2010-08-01 (estimated), first posted 2009-06-22, last updated 2009-06-22
Locations	1 site in Brazil

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Isoflavone	Experimental	Drug: Isoflavone	Patients will receive daily doses of 150 mg of concentrated extract of soy per os
Control	Placebo comparator	Drug: Placebo	Patients will receive daily placebo pills

Isoflavone (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.
Placebo (Drug): Starch pill

+Outcome measures

Primary outcomes

Concentration of serum DDimer [3 months]

+Eligibility

Sex: Female, ages: 45 Years to 65 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Ambulatório de Ginecologia Endócrina	São Paulo, São Paulo	Brazil

+Investigators

Mauro A Aidar, M.D., PhD., Study chair, Universidade Federal de São Paulo