Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer
NCT ID: NCT00268892
Last Updated: 2010-12-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
278 participants
INTERVENTIONAL
2006-01-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Degarelix 240/240@40(1-3-6-9)
Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Degarelix
Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.
Degarelix 240/240@60(1-3-6-9)
Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Degarelix
Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.
Degarelix 240/240@60(1-4-7-10)
Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Degarelix
Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.
Interventions
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Degarelix
Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.
Degarelix
Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.
Degarelix
Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has successfully completed the main study.
Exclusion Criterion:
\- Has been withdrawn from the main study.
18 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Ferring Pharmaceuticals
Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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UZ Gasthuisberg Leuven
Leuven, , Belgium
Helsinki University Hospital, Maria Hospital, Building 11
Helsinki, , Finland
Central Hospital, North Karelian
Joensuu, , Finland
Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Fédération d'Urologie et Néphrologie, BP69 Hôpital Pasteur
Nice, , France
Gemeinschaftspraxis Dres Effert und Benedic
Aachen, , Germany
Clinical Center Novi Sad, Clinic of Urology
Novi Sad, , Montenegro
Academic Medical Center, Urology
Amsterdam, , Netherlands
St. Elisabeth Hospital
Tilburg, , Netherlands
"Centrul Medical Privat" Prof. Dr. Ioiart Ioan"
Arad, , Romania
Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department
Bucharest, , Romania
University CF Hospital No. 2
Bucharest, , Romania
Andros Clinic
Saint Petersburg, , Russia
City Hospital #15
Saint Petersburg, , Russia
City Hospital #26
Saint Petersburg, , Russia
Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department
Saint Petersburg, , Russia
Pavlov State Medical University, Urology Department
Saint Petersburg, , Russia
Clinical Center of Serbia, Institute of Urology and Nephrology
Belgrade, , Serbia
Mount Vernon Cancer Centre, Marie Cuire Research Wing
Northwood, Middlesex, United Kingdom
Castle Hill Hospital
Hull, North Humberside, United Kingdom
Ward 13, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary, Majors Loans
Falkirk, , United Kingdom
Level 7, Urology Research Unit, Derriford Hospital
Plymouth, , United Kingdom
Countries
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Other Identifiers
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FE200486 CS15A
Identifier Type: -
Identifier Source: org_study_id