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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000357-20 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection A | Active Comparator | Degarelix s.c. standard injections |
|
| Injection B | Experimental | Degarelix s.c. optimised injections |
|
| Injection C | Experimental | Degarelix i.m. injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| degarelix | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | From baseline to month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From starting dose to 6 days after starting dose |
| Patient reported injection site pain scores after degarelix maintenance doses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampereen yliopistollinen sairaala (there may be other sites in this country) | Tampere | Finland | ||||
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
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Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain) |
| 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 | From baseline to month 6 |
| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |