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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT00117286
• Lead Sponsor: Ferring Pharmaceuticals

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 Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-06
• Primary Completion: 2009-09
• Study Completion: 2009-11
• Status Verified: 2010-09
• Results First Submitted: 2010-09-29
• Results First Submitted QC: 2010-09-29
• Last Update Submitted: 2010-09-29
• Results First Posted: 2010-10-21
• Last Update Posted: 2010-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 57

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• Has been withdrawn from the FE200486 CS14 study.

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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 (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.

Trial Locations

Locations (22)

Regional Urology; 🇺🇸 Shreveport, Louisiana, United States

Lawrenceville Urology; 🇺🇸 Lawrenceville, New Jersey, United States

The Male and Female Health and Research Centers; 🇨🇦 Barrie, Ontario, Canada

West Coast Clinical Research; 🇺🇸 Tarzana, California, United States

Western Clinical Research; 🇺🇸 Torrance, California, United States

The Urology Center; 🇺🇸 Greensboro, North Carolina, United States

University Urological Research Institute; 🇺🇸 Providence, Rhode Island, United States

SW Florida Urological Associates; 🇺🇸 Fort Myers, Florida, United States

Urology Associate PC'; 🇺🇸 Denver, Colorado, United States

South Florida Medical Research; 🇺🇸 Aventura, Florida, United States

Northeast Indiana Research, LLC; 🇺🇸 Fort Wayne, Indiana, United States

Advanced Urology Medical Center; 🇺🇸 Anaheim, California, United States

Urology Centers of Alabama; 🇺🇸 Homewood, Alabama, United States

Investigational site; 🇺🇸 Seattle, Washington, United States

State College Urologic Association; 🇺🇸 State College, Pennsylvania, United States

University of Vermont, Dept of Surgery; 🇺🇸 South Burlington, Vermont, United States

Urology San Antonio Research; 🇺🇸 San Antonio, Texas, United States

Virginia Urology Center; 🇺🇸 Richmond, Virginia, United States

Can-Med Clinical Research, Inc.; 🇨🇦 Victoria, British Columbia, Canada

Brantford Urology Research; 🇨🇦 Brantford, Ontario, Canada

The Female/Male Health Centres; 🇨🇦 Oakville, Ontario, Canada

Burlington Professional Care; 🇨🇦 Burlington, Ontario, Canada