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Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00117286
First received: June 30, 2005
Last updated: September 29, 2010
Last verified: September 2010

June 30, 2005
September 29, 2010
March 2005
September 2009   (final data collection date for primary outcome measure)
  • Participants With Markedly Abnormal Change in Vital Signs and Body Weight [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.
  • Liver Function Tests [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.
To demonstrate the efficacy of degarelix to evaluate safety and tolerability
Complete list of historical versions of study NCT00117286 on ClinicalTrials.gov Archive Site
Not Provided
To evaluate the pharmacokinetics and safety of degarelix
Not Provided
Not Provided
 
Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer

This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.

The study was terminated when all ongoing participants had been treated for at least 5 years.

Participants who completed the main FE200486 CS14 study initially continued with the same dose in the FE200486 CS14A extension study. A protocol amendment changed the dosage to 160 mg (40 mg/mL) for all study participants.

The data include data from the participants who participated in both the main study (FE200486 CS14; NCT00116779) and the extension study FE200486 CS14A.

Interventional
Phase 2
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 supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
Other Name: Degarelix acetate, FE200486
  • Experimental: Degarelix (60 mg to 160 mg)
    Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
    Intervention: Drug: Degarelix
  • Experimental: Degarelix (80 mg to 160 mg)
    Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
    Intervention: Drug: Degarelix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
November 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has given written consent prior to any study-related activity being performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
  • Has completed study FE200486 CS14 through visit 22.

Exclusion Criterion:

  • Has been withdrawn from the FE200486 CS14 study.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00117286
FE200486 CS14A
No
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
September 2010

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