Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer
1 other identifier
interventional
57
2 countries
22
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 Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 prostate-cancer
Started Mar 2005
Typical duration for phase_2 prostate-cancer
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 6, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
October 21, 2010
CompletedDecember 18, 2025
September 1, 2010
4.5 years
June 30, 2005
September 29, 2010
December 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
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.
5 years
Liver Function Tests
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.
5 years
Study Arms (2)
Degarelix (60 mg to 160 mg)
EXPERIMENTALParticipants 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.
Degarelix (80 mg to 160 mg)
EXPERIMENTALParticipants 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.
Interventions
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
Eligibility Criteria
You may qualify if:
- 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.
- Has been withdrawn from the FE200486 CS14 study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Advanced Urology Medical Center
Anaheim, California, 92801, United States
West Coast Clinical Research
Tarzana, California, 91356, United States
Western Clinical Research
Torrance, California, 90505, United States
Urology Associate PC'
Denver, Colorado, 80210, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
SW Florida Urological Associates
Fort Myers, Florida, 33907, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, 46825, United States
Regional Urology
Shreveport, Louisiana, 71106, United States
Lawrenceville Urology
Lawrenceville, New Jersey, 08648, United States
The Urology Center
Greensboro, North Carolina, 27401, United States
State College Urologic Association
State College, Pennsylvania, 16801, United States
University Urological Research Institute
Providence, Rhode Island, 02904, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
University of Vermont, Dept of Surgery
South Burlington, Vermont, 05403, United States
Virginia Urology Center
Richmond, Virginia, 23235, United States
Investigational site
Seattle, Washington, 98166, United States
Can-Med Clinical Research, Inc.
Victoria, British Columbia, V8T5G1, Canada
The Male and Female Health and Research Centers
Barrie, Ontario, L4M7G1, Canada
Brantford Urology Research
Brantford, Ontario, N3R4N3, Canada
Burlington Professional Care
Burlington, Ontario, L7N3V2, Canada
The Female/Male Health Centres
Oakville, Ontario, L6H3P1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ferring Pharmaceuticals
- Organization
- Clinical Development Support
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 6, 2005
Study Start
March 1, 2005
Primary Completion
September 1, 2009
Study Completion
November 1, 2009
Last Updated
December 18, 2025
Results First Posted
October 21, 2010
Record last verified: 2010-09