Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

• Liver Function Tests [ Time Frame: 3 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.
• Participants With Markedly Abnormal Change in Vital Signs and Body Weight [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  Vital signs and body weight 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 patients in each group with normal baseline and markedly abnormal value post-baseline.

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

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.

• Drug: Degarelix
  Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
  Other Name: FE200486
• Drug: Degarelix
  Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
  Other Name: FE200486
• Drug: Degarelix
  Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
  Other Name: FE200486
• Drug: Degarelix
  Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
  Other Name: FE200486
• Drug: Degarelix
  Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
  Other Name: FE200486
• Drug: Degarelix
  Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
  Other Name: FE200486
• Drug: Degarelix
  Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
  Other Name: FE200486
• Drug: Degarelix
  Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
  Other Name: FE200486

• Experimental: Degarelix 120 mg (20 mg/mL)
  Degarelix 120 mg (20 mg/mL)
  Intervention: Drug: Degarelix
• Experimental: Degarelix 120 mg (40 mg/mL)
  Degarelix 120 mg (40 mg/mL)
  Intervention: Drug: Degarelix
• Experimental: Degarelix 160 mg (40 mg/mL)
  Degarelix 160 mg (40 mg/mL)
  Intervention: Drug: Degarelix
• Experimental: Degarelix 200 mg (40 mg/mL)
  Degarelix 200 mg (40 mg/mL)
  Intervention: Drug: Degarelix
• Experimental: Degarelix 200 mg (60 mg/mL)
  Degarelix 200 mg (60 mg/mL)
  Intervention: Drug: Degarelix
• Experimental: Degarelix 240 mg (40 mg/mL)
  Degarelix 240 mg (40 mg/mL)
  Intervention: Drug: Degarelix
• Experimental: Degarelix 240 mg (60 mg/mL)
  Degarelix 240 mg (60 mg/mL)
  Intervention: Drug: Degarelix
• Experimental: Degarelix 320 mg (60 mg/mL)
  Degarelix 320 mg (60 mg/mL)
  Intervention: Drug: Degarelix

Inclusion Criteria:

• Males aged 18 or over
• Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
• Has completed Study FE200486 CS07
• Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07