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A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00967018
Recruitment Status : Completed
First Posted : August 27, 2009
Results First Posted : December 24, 2012
Last Update Posted : January 3, 2013
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Degarelix Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer
Study Start Date : August 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Degarelix
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
Drug: Degarelix



Primary Outcome Measures :
  1. Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables [ Time Frame: Up to 22.5 months ]
    The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.

  2. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: Up to 22.5 months ]
    This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.


Other Outcome Measures:
  1. Serum Levels of Prostate Specific Antigen (PSA)Over Time [ Time Frame: from baseline to 72 weeks ]
    PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)

  2. Serum Levels of Testosterone Over Time [ Time Frame: from baseline to week 72 ]
    Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)



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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:

  • Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31

Exclusion Criteria:

  • Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31

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): NCT00967018


  Show 62 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00967018     History of Changes
Other Study ID Numbers: FE200486 CS34
EudraCT No: 2008-006827-29
First Posted: August 27, 2009    Key Record Dates
Results First Posted: December 24, 2012
Last Update Posted: January 3, 2013
Last Verified: January 2013

Keywords provided by Ferring Pharmaceuticals:
Safety parameters
ECG, blood and urine samples
general health state

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases