Clinical trial NCT00215683: An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer
Official title: An Open-Label, Multi-Centre, Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots 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: 2005-09-22
Enrollment: 137
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: 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 Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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.

Eligibility criteria: Inclusion criteria:

* Had given written consent before any study-related activity was performed (a study-related activity was defined as any procedure that would not have been performed during the normal management of the participant)
* Had completed the FE200486 CS12 study

Exclusion criterion:

* Had been withdrawn from the FE200486 CS12 study

Primary outcomes:
measure: Participants With Markedly Abnormal Change in Vital Signs and Body Weight
timeFrame: 5 years
measure: Liver Function Tests
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: UCL Saint Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Gasthuisberg, Urology Department
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban, Klinik für Urologie
city: Mannheim
country: Germany
facility: Urologische Universitätsklinikum, Klinikum Mannheim GmbH, Fakultät für Klinische Medizin Mannheim
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Hospital, of local Government of Budapest, Dept. of Urology
city: Budapest
country: Hungary
facility: Jahn Ferenc Dél-Pesti Hospital, Dept. of Urology
city: Györ
country: Hungary
facility: Pez Aladar County Hospital, Dept. of Urology
city: Kecskemét
country: Hungary
facility: Bács-Kiskun County Hospital, Dept. of Urology
city: Miskolc
country: Hungary
facility: BAZ County Hospital, Dept of Urology
city: Szeged
country: Hungary
facility: Hospital of Local Government of Szeged, Dept. of Urology
city: Szolnok
country: Hungary
facility: MÁV Hospital, Dept. of Urology
city: Amsterdam
country: Netherlands
facility: Academic Medical Center, Dept. of Urology
city: Heerlen
country: Netherlands
facility: Atrium MC, Dept. of Urology
city: Bucharest
country: Romania
facility: "Prof.Dr.Th.Burghele" Hospital - Bucharest
city: Bucharest
country: Romania
facility: "Sf. Ioan" Emergency Hospital - Urology Department
city: Bucharest
country: Romania
facility: CF2 Hospital - Bucharest, Urology Department
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute - Bucharest, Urology Department
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry, Department of Urology, Urogynecology and Andrology, City Hospital #50, Urology Department
city: Moscow
country: Russian Federation
facility: Russian Medical Academy of Postgraduate Education, Department of Gerontolology and Geriatrics, Moscow City Hospital #60, Urology Department, 84/1, Entuziastov Shosse (Hospital)
city: Moscow
country: Russian Federation
facility: Russian Medical Academy of Postgraduate Education, Urology Department, Moscow Clinical Hospital n.a. Botkin, Urology Department, 5/16, 2-oy Botkinsky proezd (Hospital)
city: Moscow
country: Russian Federation
facility: Russian State Medical University, Department of Urology and Surgical Nephrology, Moscow City Hospital #1
city: St Petersburg
country: Russian Federation
facility: City Hospital #15, Urology Department
city: St Petersburg
country: Russian Federation
facility: City Hospital #26, Urology Department
city: St Petersburg
country: Russian Federation
facility: I.I. Mechnikov St. Petersburg State Medical Academy, Urology Department
city: St Petersburg
country: Russian Federation
facility: Research Institute of Urology of the Ministry of Healthcare of the Russian Federation
city: St Petersburg
country: Russian Federation
facility: St. Petersburg Pavlov Medical School, Urology Department
city: St Petersburg
country: Russian Federation
facility: St.Petersburg Pavlov Medical School, Outpatient Diagnostic Center
city: St. Petersburg
country: Russian Federation
facility: "Andros" Urology Clinic, 36A, Lenina St.
city: Durban
country: South Africa
facility: Glenwood Hospital
city: Parktown
country: South Africa
facility: WITS Medical School, Level 9
city: Pietermaritzburg
country: South Africa
facility: 401 B Medical Centre
city: Pretoria
country: South Africa
facility: Pretoria Urology Hospital, Suite 2, Hatfield
city: Sunninghill
country: South Africa
facility: Sunninghill Clinic, Suite 3
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: