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

March 12, 2015 updated by: Ferring Pharmaceuticals

An Open-Label, Multi-Centre, Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer.

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 Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • UCL Saint Luc
      • Gent, Belgium
        • UZ Gent
      • Leuven, Belgium
        • UZ Gasthuisberg, Urology Department
  • Germany
      • Berlin, Germany
        • Vivantes Klinikum am Urban, Klinik für Urologie
      • Mannheim, Germany
        • Urologische Universitätsklinikum, Klinikum Mannheim GmbH, Fakultät für Klinische Medizin Mannheim
  • Hungary
      • Budapest, Hungary
        • Bajcsy-Zsilinszky Hospital, of local Government of Budapest, Dept. of Urology
      • Budapest, Hungary
        • Jahn Ferenc Dél-Pesti Hospital, Dept. of Urology
      • Györ, Hungary
        • Pez Aladar County Hospital, Dept. of Urology
      • Kecskemét, Hungary
        • Bács-Kiskun County Hospital, Dept. of Urology
      • Miskolc, Hungary
        • BAZ County Hospital, Dept of Urology
      • Szeged, Hungary
        • Hospital of Local Government of Szeged, Dept. of Urology
      • Szolnok, Hungary
        • MÁV Hospital, Dept. of Urology
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center, Dept. of Urology
      • Heerlen, Netherlands
        • Atrium MC, Dept. of Urology
  • Romania
      • Bucharest, Romania
        • "Prof.Dr.Th.Burghele" Hospital - Bucharest
      • Bucharest, Romania
        • "Sf. Ioan" Emergency Hospital - Urology Department
      • Bucharest, Romania
        • CF2 Hospital - Bucharest, Urology Department
      • Bucharest, Romania
        • Fundeni Clinical Institute - Bucharest, Urology Department
  • Russian Federation
      • 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, Department of Gerontolology and Geriatrics, Moscow City Hospital #60, Urology Department, 84/1, Entuziastov Shosse (Hospital)
      • 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
      • St Petersburg, Russian Federation
        • City Hospital #15, Urology Department
      • St Petersburg, Russian Federation
        • City Hospital #26, 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
        • St. Petersburg Pavlov Medical School, Urology Department
      • St Petersburg, Russian Federation
        • St.Petersburg Pavlov Medical School, Outpatient Diagnostic Center
      • St. Petersburg, Russian Federation, 197136
        • "Andros" Urology Clinic, 36A, Lenina St.
  • South Africa
      • Durban, South Africa
        • Glenwood Hospital
      • Parktown, South Africa
        • WITS Medical School, Level 9
      • Pietermaritzburg, South Africa
        • 401 B Medical Centre
      • Pretoria, South Africa
        • Pretoria Urology Hospital, Suite 2, Hatfield
      • Sunninghill, South Africa
        • Sunninghill Clinic, Suite 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • FE200486
  • Degarelix acetate
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:
  • FE200486
  • Degarelix acetate
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:
  • FE200486
  • Degarelix acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Time Frame: 5 years
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.
5 years
Liver Function Tests
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE200486 CS12A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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