Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT00245466
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients

Detailed Description

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 CS02; NCT00819247) and the extension study FE200486 CS02A.

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-28
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Results First Submitted: 2009-01-22
• Results First Submitted QC: 2009-04-23
• Results First Posted: 2009-06-11
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 88

Inclusion Criteria

• Has completed study treatment in study FE200486 CS02.
• Has completed visit 16 in study FE200486 CS02.
• Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Degarelix 40/40 + 40	Degarelix	In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
Degarelix 80/80 + 40	Degarelix	In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
Degarelix 80 + 20	Degarelix	In the main study (FE200486 CS02; NCT00819247) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

Primary Outcome Measures

Name	Time	Method
Participants With Markedly Abnormal Change in Vital Signs and Body Weight	3 years	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.
Liver Function Tests	3 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
Serum Levels of Testosterone After 1, 2, and 3 Years	3 years