Study Assessing the Effects on Endometrium and Breast of Isoflavone in Post Menopausal Women
Recruitment status was Active, not recruiting
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Purpose
The main objective of this study is to determine the effects on the endometrium and breast of 70 mg daily dose of isoflavones.
| Condition | Intervention | Phase |
|---|---|---|
|
Postmenopause |
Drug: soy isoflavone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study Assessing the Effects on Endometrium and Breast of a Standardized Isoflavone Extract(Phytosoya) in Post Menopausal Women. |
- - Endometrial innocuity (endometrial biopsy result)
- - Mammary innocuity (mammography results)
- - climacteric symptoms
- -Lipid profile
- -gynaecological and general safety
| Estimated Enrollment: | 300 |
| Study Start Date: | June 2004 |
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.
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | 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.
Contacts and Locations| Study Chair: | Pierre MARES, Professor | Hospital of Caremeau, Nîmes, FRANCE |
| Principal Investigator: | Santiago PALACIOS, Professor | Instituto Palacios, Madrid, SPAIN |
| Principal Investigator: | Bruno PORNEL, Doctor | Brussels Menopause Center, Bruxelles, BELGIUM |
| Principal Investigator: | John EDEN, Professor | Sydney Menopause Center, Sydney, AUSTRALIA |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00235924 History of Changes |
| Other Study ID Numbers: | PHY04GE01 |
| Study First Received: | October 7, 2005 |
| Last Updated: | December 7, 2005 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Spain: Spanish Agency of Medicines Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Laboratoires Arkopharma:
|
menopause isoflavone endometrial safety breast innocuity assessment hot flushes |
ClinicalTrials.gov processed this record on May 23, 2013