Study Assessing the Effects on Endometrium and Breast of Isoflavone in Post Menopausal Women
|ClinicalTrials.gov Identifier: NCT00235924|
Recruitment Status : Unknown
Verified October 2005 by Laboratoires Arkopharma.
Recruitment status was: Active, not recruiting
First Posted : October 12, 2005
Last Update Posted : December 8, 2005
|Condition or disease||Intervention/treatment||Phase|
|Postmenopause||Drug: soy isoflavone||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study Assessing the Effects on Endometrium and Breast of a Standardized Isoflavone Extract(Phytosoya) in Post Menopausal Women.|
|Study Start Date :||June 2004|
- - Endometrial innocuity (endometrial biopsy result)
- - Mammary innocuity (mammography results)
- - climacteric symptoms
- -Lipid profile
- -gynaecological and general safety
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|