Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-30 @ 1:25 PM
Study NCT ID:
NCT00819156
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2009-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer
Sponsor:
Ferring Pharmaceuticals
Organization:
Study Overview
Official Title:
An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
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 purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.
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.
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?: