Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235924
Status:
UNKNOWN
Last Update Posted:
2005-12-08
First Post:
2005-10-07
Brief Title:
Study Assessing the Effects on Endometrium and Breast of Isoflavone in Post Menopausal Women
Sponsor:
Laboratoires Arkopharma
Organization:
Laboratoires Arkopharma
Study Overview
Official Title:
Study Assessing the Effects on Endometrium and Breast of a Standardized Isoflavone ExtractPhytosoya in Post Menopausal Women
Status:
UNKNOWN
Status Verified Date:
2005-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 yearthe same examinations will be performed
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 yearthe same examinations will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None