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
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 19, 2009 | ||||||||
| Last Updated Date | June 19, 2009 | ||||||||
| Start Date ICMJE | August 2009 | ||||||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Concentration of serum DDimer [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause | ||||||||
| Official Title ICMJE | Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Menopause | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 84 | ||||||||
| Estimated Completion Date | August 2010 | ||||||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 45 Years to 65 Years (Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Brazil | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00925639 | ||||||||
| Other Study ID Numbers ICMJE | CEP/UNIFESP 0728/08 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Plan to Share Data | Not Provided | ||||||||
| IPD Description | Not Provided | ||||||||
| Responsible Party | Regiane Helena Barros Rabelo, Departamento de Ginecologia da Universidade Federal de São Paulo | ||||||||
| Study Sponsor ICMJE | Federal University of São Paulo | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Federal University of São Paulo | ||||||||
| Verification Date | June 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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