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

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00117286
First received: June 30, 2005
Last updated: September 29, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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


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

Resource links provided by NLM:

U.S. FDA Resources

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 ]
    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.

  • 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: 57
Study Start Date: March 2005
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Degarelix acetate, FE200486

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117286

  Show 22 Study Locations
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: NCT00117286     History of Changes
Other Study ID Numbers: FE200486 CS14A
Study First Received: June 30, 2005
Results First Received: September 29, 2010
Last Updated: September 29, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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 June 18, 2013