Study Assessing the Effects on Endometrium and Breast of a Standardized Isoflavone Extract(Phytosoya) in Post Menopausal Women.
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Laboratoires Arkopharma
- Enrollment
- 300
- Primary Endpoint
- - Endometrial innocuity (endometrial biopsy result)
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
- Endometrial innocuity (endometrial biopsy result)
Secondary Outcomes
- - Mammary innocuity (mammography results)
- -gynaecological and general safety
- - climacteric symptoms
- -Lipid profile