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A Degarelix Trial in Patients With Prostate Cancer

This study has been terminated.
(Inadequate recruitment resulting in a too low patient number for collection of long term efficacy data.)
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01242748
First received: November 16, 2010
Last updated: December 20, 2012
Last verified: December 2012
History of Changes

November 16, 2010
December 20, 2012
October 2010
December 2011   (final data collection date for primary outcome measure)
PSA level [ Time Frame: Every 3 months during 27 months of treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01242748 on ClinicalTrials.gov Archive Site
  • Testosterone level [ Time Frame: Every three months during 27 months of treatment ] [ Designated as safety issue: No ]
  • Blood sample assessment [ Time Frame: Every 6 months during 27 months of treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Degarelix Trial in Patients With Prostate Cancer
An Open-label, Multi-Centre, Extension Trial, Evaluating the Long-Term Progression-Free Survival of Degarelix or Goserelin Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Degarelix
  • Drug: Zoladex
  • Experimental: A.
    Intervention: Drug: Degarelix
  • Active Comparator: B.
    Intervention: Drug: Zoladex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
288
January 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has given written consent prior to any trial-related activity is performed. (A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
  • Has completed the CS35 trial.

Exclusion Criteria:

  • Has been withdrawn from the CS35 trial.
  • Has had end of trial visit in CS35 prior to approval of the CS35A protocol.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Czech Republic,   Finland,   Germany,   Hungary,   Mexico,   Netherlands,   Poland,   Romania,   Ukraine,   United Kingdom
Russian Federation
 
NCT01242748
FE200486 CS35A, 2010-021434-55
Yes
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP