Study Assessing the Effects on Endometrium and Breast of Isoflavone in Post Menopausal Women
Recruitment status was: Active, not recruiting
|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
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235924
|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|