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

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ClinicalTrials.gov Identifier: NCT00245466
Recruitment Status : Terminated (The maintenance doses were too low to maintain testosterone suppression)
First Posted : October 28, 2005
Results First Posted : June 11, 2009
Last Update Posted : May 20, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Degarelix Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : October 2001
Primary Completion Date : March 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Degarelix
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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


Secondary Outcome Measures :
  1. Serum Levels of Testosterone After 1, 2, and 3 Years [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245466


Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00245466     History of Changes
Other Study ID Numbers: FE200486 CS02A
First Posted: October 28, 2005    Key Record Dates
Results First Posted: June 11, 2009
Last Update Posted: May 20, 2011
Last Verified: May 2011

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