Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-27 @ 9:08 PM
Study NCT ID:
NCT00245466
Status:
TERMINATED
Last Update Posted:
2011-05-20
First Post:
2005-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients
Sponsor:
Ferring Pharmaceuticals
Organization:
Study Overview
Official Title:
An Open-Label, Multi-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients.
Status:
TERMINATED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The maintenance doses were too low to maintain testosterone suppression
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the long-term safety and tolerability of repeated doses of degarelix to 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 CS02; NCT00819247) and the extension study FE200486 CS02A.
The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.
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?: