Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Federal University of São Paulo.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Federal University of São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00925639
First received: June 19, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Menopause |
Drug: Isoflavone Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause |
Resource links provided by NLM:
Further study details as provided by Federal University of São Paulo:
Primary Outcome Measures:
- Concentration of serum DDimer [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 84 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Isoflavone
Patients will receive daily doses of 150 mg of concentrated extract of soy per os
|
Drug: Isoflavone
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 Comparator: Control
Patients will receive daily placebo pills
|
Drug: Placebo
Starch pill
|
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925639
Contacts
| Contact: Regiane HB Rabelo, MD | 5511-72307128 | gianehelena@ig.com.br |
| Contact: Teresa R Embiruçu, MD | 5511-74513521 | embirucu2@yahoo.com.br |
Locations
| Brazil | |
| Ambulatório de Ginecologia Endócrina | Recruiting |
| São Paulo, Brazil, 04039-060 | |
| Contact: Maria Cecília Santos, Nurse 5511-55496174 mc.santos@hotmail.com | |
| Principal Investigator: Regiane HB Rabelo, M.D. | |
Sponsors and Collaborators
Federal University of São Paulo
Investigators
| Study Chair: | Mauro A Aidar, M.D., PhD. | Universidade Federal de São Paulo |
More Information
Additional Information:
No publications provided
| Responsible Party: | Regiane Helena Barros Rabelo, Departamento de Ginecologia da Universidade Federal de São Paulo |
| ClinicalTrials.gov Identifier: | NCT00925639 History of Changes |
| Other Study ID Numbers: | CEP/UNIFESP 0728/08 |
| Study First Received: | June 19, 2009 |
| Last Updated: | June 19, 2009 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
phytoestrogen coagulation menopause |
ddimer antithrombin hypercoagulation |
ClinicalTrials.gov processed this record on May 21, 2013