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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isoflavone | Experimental | Patients will receive daily doses of 150 mg of concentrated extract of soy per os |
|
| Control | Placebo Comparator | Patients will receive daily placebo pills |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of serum DDimer | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Regiane HB Rabelo, MD | Contact | 5511-72307128 | gianehelena@ig.com.br | |
| Teresa R Embiruçu, MD | Contact | 5511-74513521 | embirucu2@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Mauro A Aidar, M.D., PhD. | Universidade Federal de SĂŁo Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AmbulatĂłrio de Ginecologia EndĂłcrina | SĂŁo Paulo | SĂŁo Paulo | 04039-060 | Brazil |
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| Label | URL |
|---|---|
| Universidade Federal de Sao Paulo's web page | View source |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D019851 | Thrombophilia |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D007529 | Isoflavones |
| ID | Term |
|---|---|
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Placebo | Drug | Starch pill |
|
| D006425 |
| Hemic and Lymphatic Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |