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Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients

This study has been terminated.
(The maintenance doses were too low to maintain testosterone suppression)
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00245466
First received: October 26, 2005
Last updated: May 18, 2011
Last verified: May 2011
History of Changes
  Purpose

To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients


Condition Intervention Phase
Prostate Cancer
 Drug: Degarelix
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients.

Resource links provided by NLM:

Drug Information available for: Degarelix
U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Liver Function Tests [ Time Frame: 3 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.

  • Participants With Markedly Abnormal Change in Vital Signs and Body Weight [ Time Frame: 3 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 patients in each group with normal baseline and markedly abnormal value post-baseline.


Secondary Outcome Measures:
  • Serum Levels of Testosterone After 1, 2, and 3 Years [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: October 2001
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Degarelix 80/80 + 40
In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
 Drug: Degarelix
Given as a subcutaneous injection once every 4 weeks.
Other Name: FE200486
Experimental: Degarelix 40/40 + 40
In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
 Drug: Degarelix
Given as a subcutaneous injection once every 4 weeks.
Other Name: FE200486
Experimental: Degarelix 80 + 20
In the main study (FE200486 CS02; NCT00819247) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
 Drug: Degarelix
Given as a subcutaneous injection once every 4 weeks.
Other Name: FE200486

Detailed Description:

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").

The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.

  Eligibility

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

Inclusion Criteria:

  • Has completed study treatment in study FE200486 CS02.
  • Has completed visit 16 in study FE200486 CS02.
  • Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245466

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: NCT00245466     History of Changes
Other Study ID Numbers: FE200486 CS02A
Study First Received: October 26, 2005
Results First Received: January 22, 2009
Last Updated: May 18, 2011
Health Authority: United Kingdom: National Health Service

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 May 23, 2013