Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT00215657
Status:
TERMINATED
Last Update Posted:
2011-05-20
First Post:
2005-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Sponsor:
Ferring Pharmaceuticals
Organization:
Study Overview
Official Title:
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Status:
TERMINATED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The doses were not effective in maintaining testosterone suppression
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Detailed Description:
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").
The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.
The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.
Study Oversight
Has Oversight DMC:
False
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?: