Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2009
CompletedFirst Posted
Study publicly available on registry
June 22, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedJune 22, 2009
June 1, 2009
5 months
June 19, 2009
June 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concentration of serum DDimer
3 months
Study Arms (2)
Isoflavone
EXPERIMENTALPatients will receive daily doses of 150 mg of concentrated extract of soy per os
Control
PLACEBO COMPARATORPatients will receive daily placebo pills
Interventions
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.
Eligibility Criteria
You may qualify if:
- \> 1 year of amenorrhea
- to 65 years old
- without hormone reposition treatment or herbal medications in the 6 months preceding the research
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ambulatório de Ginecologia Endócrina
São Paulo, São Paulo, 04039-060, Brazil
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mauro A Aidar, M.D., PhD.
Universidade Federal de São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 19, 2009
First Posted
June 22, 2009
Study Start
August 1, 2009
Primary Completion
January 1, 2010
Study Completion
August 1, 2010
Last Updated
June 22, 2009
Record last verified: 2009-06