Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT01269320
Status:
WITHDRAWN
Last Update Posted:
2012-08-28
First Post:
2011-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Natural Soybean-derived Femarelle ®for Patients With Non Alcoholic Fatty Liver Disease
Sponsor:
Hadassah Medical Organization
Organization:
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsors decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Single -arm, open-label, before-and after exploratory trial of 90 days of Femarelle ® to improve NAFLD and the metabolic syndrome.
Ingestion of Femarelle will improve non alcoholic steatohepatitis and the metabolic syndrome in patients suffering from these conditions.
Subjects will receive treatment with Femarele 530 mg (1 capsule twice a day) for 90 days and will then be monitored off study treatment for an additional 4 weeks.
Ingestion of Femarelle will improve non alcoholic steatohepatitis and the metabolic syndrome in patients suffering from these conditions.
Subjects will receive treatment with Femarele 530 mg (1 capsule twice a day) for 90 days and will then be monitored off study treatment for an additional 4 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: