Status:
UNKNOWN
Study Assessing the Effects on Endometrium and Breast of Isoflavone in Post Menopausal Women
Lead Sponsor:
Laboratoires Arkopharma
Conditions:
Postmenopause
Eligibility:
FEMALE
45-65 years
Phase:
PHASE3
Brief Summary
The main objective of this study is to determine the effects on the endometrium and breast of 70 mg daily dose of isoflavones.
Detailed Description
This is an international multicentre open study, assessing the innocuity on breast and endometrium of a 70 mg daily dose of isoflavones standardized extract (Phytosoya). This study follows the Europe...
Eligibility Criteria
Inclusion
- Not hysterectomised women
- 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
- History of endometrial hyperplasia
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00235924
Start Date
June 1 2004
Last Update
December 8 2005
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