An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT00215683
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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 (including one year in the main study).

Detailed Description

Participants who completed the main FE200486 CS12 study initially continued with the same dose in the FE200486 CS12A extension study. After a protocol amendment all study participants were treated with 160 mg (40 mg/mL).

The data include data from the participants who participated in both the main study (FE200486 CS12; NCT00819156) and the extension study FE200486 CS12A.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2009-10
• Study Completion: 2009-11
• Results First Submitted: 2010-11-12
• Results First Submitted QC: 2010-11-12
• Results First Posted: 2010-12-14
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 137

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Degarelix 80 mg	Degarelix	Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Degarelix 120 mg	Degarelix	Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Degarelix 160 mg	Degarelix	Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).

Primary Outcome Measures

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

Trial Locations

Locations (34)

UCL Saint Luc; 🇧🇪 Bruxelles, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

UZ Gasthuisberg, Urology Department; 🇧🇪 Leuven, Belgium

Vivantes Klinikum am Urban, Klinik für Urologie; 🇩🇪 Berlin, Germany

Urologische Universitätsklinikum, Klinikum Mannheim GmbH, Fakultät für Klinische Medizin Mannheim; 🇩🇪 Mannheim, Germany

Bajcsy-Zsilinszky Hospital, of local Government of Budapest, Dept. of Urology; 🇭🇺 Budapest, Hungary

Jahn Ferenc Dél-Pesti Hospital, Dept. of Urology; 🇭🇺 Budapest, Hungary

Pez Aladar County Hospital, Dept. of Urology; 🇭🇺 Györ, Hungary

Bács-Kiskun County Hospital, Dept. of Urology; 🇭🇺 Kecskemét, Hungary

BAZ County Hospital, Dept of Urology; 🇭🇺 Miskolc, Hungary

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