A Long Term Safety Study of Degarelix in Patients With Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00967018|
Recruitment Status : Completed
First Posted : August 27, 2009
Results First Posted : December 24, 2012
Last Update Posted : January 3, 2013
|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)|
|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|
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.
- 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.
- 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.
- 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)
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967018
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|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|