Study Assessing the Effects on Endometrium and Breast of Isoflavone in Post Menopausal Women
NCT ID: NCT00235924
Last Updated: 2005-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
2004-06-30
Brief Summary
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Detailed Description
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This study follows the European guidelines :one-year treatment duration, biopsy and mammography performed at the beginning and at the end of the trial, recruitment of enough subjects in order to have 300 patients with an evaluable biopsy after one year of treatment.
After 3 weeks of screening phase, the patients will be taken Phytosoya during 52 weeks. At the end of the first year of treatment, an endometrial biopsy, an endovaginal ultrasonography, a mammography, breast ultrasounds, a clinical examination and a biological assessment will be performed.
In addition, it will be proposed to patients to continue treatment during 2 additional years. At the end of the third year,the same examinations will be performed.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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soy isoflavone
Eligibility Criteria
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Inclusion Criteria
* Post menopausal (at least 2 years)
* FSH superior to 30 UI/l and oestradiol inferior to 35 ng/ml
* Presenting with hot flushes (but not incapacitating) or climacteric symptoms
Exclusion Criteria
* Known hormono-dependent malignant tumours
* BMI superior to 30 Kg/m2
* Uncontrolled arterial hypertension
* Known renal or liver insufficiency
* Recent or evolutive thromboembolic disease
* Unexplained bleeding, endometrial polyps, submucous myomas, active endometriosis, ovarian cyst superior to 30 mm
* Local hormonal treatment, raloxifene,tibolone within the 3 months before V1 and during the study
* HRT and DHEA within the 3 months before V2 and during the study
* isoflavones within the 2 months before V2 and during the study
* clonidine, beta-alanine, veralipride within 1 month before V1 and during the study.
45 Years
65 Years
FEMALE
No
Sponsors
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Laboratoires Arkopharma
INDUSTRY
Principal Investigators
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Pierre MARES, Professor
Role: STUDY_CHAIR
Hospital of Caremeau, Nîmes, FRANCE
Santiago PALACIOS, Professor
Role: PRINCIPAL_INVESTIGATOR
Instituto Palacios, Madrid, SPAIN
Bruno PORNEL, Doctor
Role: PRINCIPAL_INVESTIGATOR
Brussels Menopause Center, Bruxelles, BELGIUM
John EDEN, Professor
Role: PRINCIPAL_INVESTIGATOR
Sydney Menopause Center, Sydney, AUSTRALIA
Other Identifiers
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PHY04GE01
Identifier Type: -
Identifier Source: org_study_id