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

Federal University of São Paulo

Status and phase: Unknown; Phase 3

Conditions: Menopause

Treatments: Drug: Placebo; Drug: Isoflavone

Study type: Interventional

Funder types: Other

Identifiers

NCT00925639

CEP/UNIFESP 0728/08

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

Isoflavone

Experimental group

Description:

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

Treatment:

Drug: Isoflavone

Control

Placebo Comparator group

Description:

Patients will receive daily placebo pills

Treatment:

Drug: Placebo