The purpose of this trial is to compare the severity of ISRs (Injection Site Reactions) following degarelix subcutaneous (s.c.) administrations with two different injection techniques and intramuscular (i.m.) administration in patients with hormone dependent prostate cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Tampereen yliopistollinen sairaala (there may be other sites in this country)
Tampere, Finland
Groupe Hospitalier Pellegrin Tripode (there may be other sites in this country)
Bordeaux, France
Universitaetsklinikum Freiburg (there may be other sites in this country)
Freiburg im Breisgau, Germany
Difference in the average patient reported injection site pain score between patients receiving the optimised and standard s.c. injections, as well as between patients receiving the i.m. and standard s.c. injections
Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)
Time frame: From baseline to month 6
Patient reported injection site pain scores after degarelix starting dose
Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)
Time frame: From starting dose to 6 days after starting dose
Patient reported injection site pain scores after degarelix maintenance doses
Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)
Time frame: From first maintenance dose (month 1) to 6 days after last maintenance dose (month 6)
Difference in skin colour values between pre- and post-injection
Average of 4 measurements on skin redness at the injection site using DSM II ColorMeter
Time frame: From baseline to month 6
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