An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00215683
First received: September 20, 2005
Last updated: November 12, 2010
Last verified: November 2010
  Purpose

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 Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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 (inluding one year in the main study).


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Participants With Markedly Abnormal Change in Vital Signs and Body Weight [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Vital signs and body weight 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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 137
Study Start Date: February 2005
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Degarelix 80 mg
Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Drug: Degarelix
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.
Other Names:
  • Degarelix acetate
  • FE200486
Experimental: Degarelix 120 mg
Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Drug: Degarelix
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.
Other Names:
  • Degarelix acetate
  • FE200486
Experimental: Degarelix 160 mg
Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Drug: Degarelix
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.
Other Names:
  • Degarelix acetate
  • FE200486

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215683

Locations
Belgium
UCL Saint Luc
Bruxelles, Belgium
UZ Gent
Gent, Belgium
UZ Gasthuisberg, Urology Department
Leuven, Belgium
Germany
Vivantes Klinikum am Urban, Klinik für Urologie
Berlin, Germany
Urologische Universitätsklinikum, Klinikum Mannheim GmbH, Fakultät für Klinische Medizin Mannheim
Mannheim, Germany
Hungary
Jahn Ferenc Dél-Pesti Hospital, Dept. of Urology
Budapest, Hungary
Bajcsy-Zsilinszky Hospital, of local Government of Budapest, Dept. of Urology
Budapest, Hungary
Pez Aladar County Hospital, Dept. of Urology
Györ, Hungary
Bács-Kiskun County Hospital, Dept. of Urology
Kecskemét, Hungary
BAZ County Hospital, Dept of Urology
Miskolc, Hungary
Hospital of Local Government of Szeged, Dept. of Urology
Szeged, Hungary
MÁV Hospital, Dept. of Urology
Szolnok, Hungary
Netherlands
Academic Medical Center, Dept. of Urology
Amsterdam, Netherlands
Atrium MC, Dept. of Urology
Heerlen, Netherlands
Romania
"Prof.Dr.Th.Burghele" Hospital - Bucharest
Bucharest, Romania
CF2 Hospital - Bucharest, Urology Department
Bucharest, Romania
Fundeni Clinical Institute - Bucharest, Urology Department
Bucharest, Romania
"Sf. Ioan" Emergency Hospital - Urology Department
Bucharest, Romania
Russian Federation
Russian Medical Academy of Postgraduate Education, Department of Gerontolology and Geriatrics, Moscow City Hospital #60, Urology Department, 84/1, Entuziastov Shosse (Hospital)
Moscow, Russian Federation
Moscow State University of Medicine and Dentistry, Department of Urology, Urogynecology and Andrology, City Hospital #50, Urology Department
Moscow, Russian Federation
Russian Medical Academy of Postgraduate Education, Urology Department, Moscow Clinical Hospital n.a. Botkin, Urology Department, 5/16, 2-oy Botkinsky proezd (Hospital)
Moscow, Russian Federation
Russian State Medical University, Department of Urology and Surgical Nephrology, Moscow City Hospital #1
Moscow, Russian Federation
St.Petersburg Pavlov Medical School, Outpatient Diagnostic Center
St Petersburg, Russian Federation
St. Petersburg Pavlov Medical School, Urology Department
St Petersburg, Russian Federation
City Hospital #26, Urology Department
St Petersburg, Russian Federation
City Hospital #15, Urology Department
St Petersburg, Russian Federation
I.I. Mechnikov St. Petersburg State Medical Academy, Urology Department
St Petersburg, Russian Federation
Research Institute of Urology of the Ministry of Healthcare of the Russian Federation
St Petersburg, Russian Federation
"Andros" Urology Clinic, 36A, Lenina St.
St. Petersburg, Russian Federation, 197136
South Africa
Glenwood Hospital
Durban, South Africa
WITS Medical School, Level 9
Parktown, South Africa
401 B Medical Centre
Pietermaritzburg, South Africa
Pretoria Urology Hospital, Suite 2, Hatfield
Pretoria, South Africa
Sunninghill Clinic, Suite 3
Sunninghill, South Africa
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00215683     History of Changes
Other Study ID Numbers: FE200486 CS12A
Study First Received: September 20, 2005
Results First Received: November 12, 2010
Last Updated: November 12, 2010
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Romania: Ministry of Public Health
Romania: National Authority for Scientific Research
Romania: National Medicines Agency
Romania: State Institute for Drug Control
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
South Africa: Department of Health
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
Hungary: National Institute of Pharmacy

Keywords provided by Ferring Pharmaceuticals:
Prostate Cancer
Androgen ablation therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014