Clinical trial NCT00268892: Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer
Official title: An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Different Three-Month Degarelix Dosing Regimens in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Androgen ablation therapy
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 278
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix.

Detailed description: The data include data from the participants who participated in both the main study FE200486 CS15 (NCT00113753) and the extension study FE200486 CS15A.

Eligibility criteria: Inclusion Criteria:

* Has given written consent prior to any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
* Has successfully completed the main study.

Exclusion Criterion:

- Has been withdrawn from the main study.

Primary outcomes:
measure: Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
timeFrame: Baseline and up to 4.5 years
measure: Liver Function Tests
timeFrame: 4.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Gasthuisberg Leuven
city: Helsinki
country: Finland
facility: Helsinki University Hospital, Maria Hospital, Building 11
city: Joensuu
country: Finland
facility: Central Hospital, North Karelian
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Nice
country: France
facility: Fédération d'Urologie et Néphrologie, BP69 Hôpital Pasteur
city: Aachen
country: Germany
facility: Gemeinschaftspraxis Dres Effert und Benedic
city: Novi Sad
country: Montenegro
facility: Clinical Center Novi Sad, Clinic of Urology
city: Amsterdam
country: Netherlands
facility: Academic Medical Center, Urology
city: Tilburg
country: Netherlands
facility: St. Elisabeth Hospital
city: Arad
country: Romania
facility: "Centrul Medical Privat" Prof. Dr. Ioiart Ioan"
city: Bucharest
country: Romania
facility: Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department
city: Bucharest
country: Romania
facility: University CF Hospital No. 2
city: St. Petersburg
country: Russian Federation
facility: Andros Clinic
city: St. Petersburg
country: Russian Federation
facility: City Hospital #15
city: St. Petersburg
country: Russian Federation
facility: City Hospital #26
city: St. Petersburg
country: Russian Federation
facility: Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department
city: St. Petersburg
country: Russian Federation
facility: Pavlov State Medical University, Urology Department
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia, Institute of Urology and Nephrology
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre, Marie Cuire Research Wing
state: Middlesex
city: Hull
country: United Kingdom
facility: Castle Hill Hospital
state: North Humberside
city: Falkirk
country: United Kingdom
facility: Ward 13, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary, Majors Loans
city: Plymouth
country: United Kingdom
facility: Level 7, Urology Research Unit, Derriford Hospital
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: