Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

September 29, 2010 updated by: Ferring Pharmaceuticals

An Open-Label, Multi-Center, Extension Study Investigating 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 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants who completed the main FE200486 CS14 study initially continued with the same dose in the FE200486 CS14A extension study. A protocol amendment changed the dosage to 160 mg (40 mg/mL) for all study participants.

The data include data from the participants who participated in both the main study (FE200486 CS14; NCT00116779) and the extension study FE200486 CS14A.

Study Type

Interventional

Enrollment (Actual)

57

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

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8T5G1
        • Can-Med Clinical Research, Inc.
    • Ontario
      • Barrie, Ontario, Canada, L4M7G1
        • The Male and Female Health and Research Centers
      • Brantford, Ontario, Canada, N3R4N3
        • Brantford Urology Research
      • Burlington, Ontario, Canada, L7N3V2
        • Burlington Professional Care
      • Oakville, Ontario, Canada, L6H3P1
        • The Female/Male Health Centres
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers Of Alabama
    • California
      • Anaheim, California, United States, 92801
        • Advanced Urology Medical Center
      • Tarzana, California, United States, 91356
        • West Coast Clinical Research
      • Torrance, California, United States, 90505
        • Western Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80210
        • Urology Associate PC'
    • Florida
      • Aventura, Florida, United States, 33180
        • South Florida Medical Research
      • Fort Myers, Florida, United States, 33907
        • SW Florida Urological Associates
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Northeast Indiana Research, LLC
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrenceville Urology
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • The Urology Center
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • State College Urologic Association
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • University Urological Research Institute
    • Texas
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • University of Vermont, Dept of Surgery
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Virginia Urology Center
    • Washington
      • Seattle, Washington, United States, 98166
        • Investigational Site

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:

  • Has given written consent prior to any study-related activity being performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
  • Has completed study FE200486 CS14 through visit 22.

Exclusion Criterion:

  • Has been withdrawn from the FE200486 CS14 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 (60 mg to 160 mg)
Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
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 (80 mg to 160 mg)
Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Time Frame: 5 years
This outcome measure 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

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

March 1, 2005

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

June 30, 2005

First Posted (Estimate)

July 6, 2005

Study Record Updates

Last Update Posted (Estimate)

October 21, 2010

Last Update Submitted That Met QC Criteria

September 29, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE200486 CS14A

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.

Clinical Trials on Prostate Cancer

Clinical Trials on Degarelix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe