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

• 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.

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 Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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.

• 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

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.