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

Phase 2

Completed

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 Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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

Detailed Description: 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.

Recruitment & Eligibility

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:

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Degarelix (80 mg to 160 mg)	Degarelix	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.
Degarelix (60 mg to 160 mg)	Degarelix	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.

Primary Outcome Measures

Name	Time	Method
Participants With Markedly Abnormal Change in Vital Signs and Body Weight	5 years	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	5 years	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.

Secondary Outcome Measures

Name	Time	Method

Locations (22): Urology Centers of Alabama
🇺🇸
Homewood, Alabama, United States
Advanced Urology Medical Center
🇺🇸
Anaheim, California, United States
West Coast Clinical Research
🇺🇸
Tarzana, California, United States
Western Clinical Research
🇺🇸
Torrance, California, United States
Urology Associate PC'
🇺🇸
Denver, Colorado, United States
South Florida Medical Research
🇺🇸
Aventura, Florida, United States
SW Florida Urological Associates
🇺🇸
Fort Myers, Florida, United States
Northeast Indiana Research, LLC
🇺🇸
Fort Wayne, Indiana, United States
Regional Urology
🇺🇸
Shreveport, Louisiana, United States
Lawrenceville Urology
🇺🇸
Lawrenceville, New Jersey, United States
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Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States