Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215657
Status:
TERMINATED
Last Update Posted:
2011-05-20
First Post:
2005-09-20
Brief Title:
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Sponsor:
Ferring Pharmaceuticals
Organization:
Ferring Pharmaceuticals
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:
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