Menopause
Conditions
Keywords
phytoestrogen, coagulation, menopause, ddimer, antithrombin, hypercoagulation
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.
Interventions
DRUGIsoflavone
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.
DRUGPlacebo
Starch pill
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of serum DDimer | 3 months |
Countries
Brazil
Contacts
Primary ContactRegiane HB Rabelo, MD
Backup ContactTeresa R Embiruçu, MD
Outcome results
None listed