Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT00831233
Status:
TERMINATED
Last Update Posted:
2013-11-11
First Post:
2009-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C431566', 'term': 'acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide'}, {'id': 'D017273', 'term': 'Goserelin'}, {'id': 'C053541', 'term': 'bicalutamide'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DK0-Disclosure@ferring.com', 'title': 'Ferring Pharmaceuticals', 'organization': 'Clinical Development Support'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': '12 weeks.', 'description': "Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.", 'eventGroups': [{'id': 'EG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)', 'otherNumAtRisk': 27, 'otherNumAffected': 14, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Goserelin (3.6 mg) + Bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)', 'otherNumAtRisk': 13, 'otherNumAffected': 7, 'seriousNumAtRisk': 13, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Reproductive tract hypoplasia, male', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 16, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Prostatic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Prostatic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)'}, {'id': 'OG001', 'title': 'Goserelin (3.6 mg) + Bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.2', 'spread': '8.29', 'groupId': 'OG000'}, {'value': '-7.69', 'spread': '7.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1973', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.95', 'ciLowerLimit': '-7.51', 'ciUpperLimit': '1.61', 'pValueComment': 'FAS.', 'groupDescription': 'Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.\n\nIf the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used.'}, {'pValue': '0.0398', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.88', 'ciLowerLimit': '-11.5', 'ciUpperLimit': '-0.291', 'pValueComment': 'PP analysis set.', 'groupDescription': 'Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.', 'testedNonInferiority': True, 'nonInferiorityComment': 'The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.\n\nIf the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used.'}], 'paramType': 'MEAN', 'timeFrame': 'After treatment of 12 weeks compared to Baseline', 'description': 'The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) + Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total IPSS at Weeks 4 and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)'}, {'id': 'OG001', 'title': 'Goserelin (3.6 mg) + Bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-7.31', 'spread': '5.83', 'groupId': 'OG000'}, {'value': '-4.62', 'spread': '5.49', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-9.46', 'spread': '6.94', 'groupId': 'OG000'}, {'value': '-8.08', 'spread': '9.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2298', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.47', 'ciLowerLimit': '-6.58', 'ciUpperLimit': '1.64', 'groupDescription': 'Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.', 'testedNonInferiority': False}, {'pValue': '0.6917', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.983', 'ciLowerLimit': '-5.98', 'ciUpperLimit': '4.02', 'groupDescription': 'Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'After treatment of 4 and 8 weeks compared to Baseline', 'description': 'The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)'}, {'id': 'OG001', 'title': 'Goserelin (3.6 mg) + Bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '3.63', 'spread': '7.82', 'groupId': 'OG000'}, {'value': '3.55', 'spread': '3.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '4.74', 'spread': '6.60', 'groupId': 'OG000'}, {'value': '3.52', 'spread': '3.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '3.62', 'spread': '7.37', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '4.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8151', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.553', 'ciLowerLimit': '-5.33', 'ciUpperLimit': '4.22', 'groupDescription': 'Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.', 'testedNonInferiority': False}, {'pValue': '0.455', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.46', 'ciLowerLimit': '-2.46', 'ciUpperLimit': '5.38', 'groupDescription': 'Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.', 'testedNonInferiority': False}, {'pValue': '0.3186', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.02', 'ciLowerLimit': '-2.04', 'ciUpperLimit': '6.08', 'groupDescription': 'Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'After treatment of 4, 8 and 12 weeks compared to Baseline', 'description': 'Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)', 'unitOfMeasure': 'mL/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Residual Volume (Vresidual) at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)'}, {'id': 'OG001', 'title': 'Goserelin (3.6 mg) + Bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-36.2', 'spread': '148', 'groupId': 'OG000'}, {'value': '-19.8', 'spread': '63.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-43.8', 'spread': '133', 'groupId': 'OG000'}, {'value': '-19.6', 'spread': '85.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-50.7', 'spread': '135', 'groupId': 'OG000'}, {'value': '-13.4', 'spread': '85.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.2', 'ciLowerLimit': '-37.8', 'ciUpperLimit': '68.2', 'groupDescription': 'Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.', 'testedNonInferiority': False}, {'pValue': '0.8284', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.91', 'ciLowerLimit': '-49.1', 'ciUpperLimit': '60.9', 'groupDescription': 'Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.', 'testedNonInferiority': False}, {'pValue': '0.5984', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.2', 'ciLowerLimit': '-34.4', 'ciUpperLimit': '58.8', 'groupDescription': 'Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'After treatment of 4, 8 and 12 weeks compared to Baseline', 'description': 'Uroflowmetry was used to quantify the residual volume (Vresidual; mL)', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)'}, {'id': 'OG001', 'title': 'Goserelin (3.6 mg) + Bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.4', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '-13.4', 'spread': '10.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.83', 'ciLowerLimit': '-17.3', 'ciUpperLimit': '1.64', 'groupDescription': 'Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'After 12 weeks treatment compared to Baseline', 'description': 'TRUS is a method of measuring the size of the prostate.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, Observed Cases (OC).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)'}, {'id': 'OG001', 'title': 'Goserelin (3.6 mg) + Bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After treatment of 4, 8 and 12 weeks compared to Baseline', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, OC.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)'}, {'id': 'OG001', 'title': 'Goserelin (3.6 mg) + Bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-85.72', 'groupId': 'OG000', 'lowerLimit': '-97.87', 'upperLimit': '234.97'}, {'value': '-93.44', 'groupId': 'OG001', 'lowerLimit': '-98.33', 'upperLimit': '-87.09'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-89.2', 'groupId': 'OG000', 'lowerLimit': '-99.47', 'upperLimit': '-31.62'}, {'value': '-97.26', 'groupId': 'OG001', 'lowerLimit': '-99.72', 'upperLimit': '-87.56'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-93.87', 'groupId': 'OG000', 'lowerLimit': '-99.83', 'upperLimit': '-64.71'}, {'value': '-97.78', 'groupId': 'OG001', 'lowerLimit': '-99.72', 'upperLimit': '-94.52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'After treatment of 4, 8 and 12 weeks compared to Baseline', 'unitOfMeasure': 'percentage', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)'}, {'id': 'OG001', 'title': 'Goserelin (3.6 mg) + Bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.96', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.54', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '2.20', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-1.77', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '1.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After treatment of 4, 8 and 12 weeks compared to Baseline', 'description': "The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL.", 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, OC.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)'}, {'id': 'OG001', 'title': 'Goserelin (3.6 mg) + Bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)'}], 'classes': [{'title': 'Diastolic blood pressure <=50 and decrease >=15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure >=105 and increase >=15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure <=90 and decrease >=20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure >=180 and increase >=20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate <=50 and decrease >=15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate >=120 and increase >=15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Body weight decrease of >=7 percent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Body weight increase of >=7 percent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 weeks of treatment', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. One participant in the degarelix group did not have any assessment of vital signs or body weight (the number of participants in this group is thus 26).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)'}, {'id': 'OG001', 'title': 'Goserelin (3.6 mg) + Bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)'}], 'classes': [{'title': 'B-Haematocrit (Ratio) <=0.37', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'B-Platelet count (10^9/L) <=75', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'S-Calcium (mmol/L) <=1.8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'S-Potassium (mmol/L) >=5.8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'S-Urea nitrogen (mmol/L) >=10.7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12 weeks of treatment', 'description': 'The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least on participant with one abnormal value are presented, many more variables were included in the trial.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)'}, {'id': 'FG001', 'title': 'Goserelin (3.6 mg) + Bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Intention-to-treat (ITT) population.', 'groupId': 'FG000', 'numSubjects': '29'}, {'comment': 'ITT population.', 'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'comment': '2 participants were randomised but never treated.', 'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Per Protocol (PP) Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Selection Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The participants were recruited by outpatient urologists. 280 participants were to be randomised in a 3:1 ratio to one of two treatment groups (210 patients were to be treated with degarelix; 70 patients were to be treated with goserelin plus bicalutamide). The trial was stopped early due to poor recruitment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)'}, {'id': 'BG001', 'title': 'Goserelin (3.6 mg) + Bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.9', 'spread': '8.68', 'groupId': 'BG000'}, {'value': '71.0', 'spread': '8.39', 'groupId': 'BG001'}, {'value': '70.3', 'spread': '8.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Full Analysis Set (FAS).', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'FAS.', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'FAS.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'FAS.', 'unitOfMeasure': 'participants'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '81.4', 'spread': '14.0', 'groupId': 'BG000'}, {'value': '78.2', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '80.3', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'FAS.', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'spread': '4.06', 'groupId': 'BG000'}, {'value': '26.8', 'spread': '3.75', 'groupId': 'BG001'}, {'value': '26.7', 'spread': '3.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'FAS.', 'unitOfMeasure': 'kilogram per square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gleason Score', 'classes': [{'title': '2-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '5-6', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': '7-10', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'FAS. The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive.', 'unitOfMeasure': 'participants'}, {'title': 'Stage of Prostate Cancer', 'classes': [{'title': 'Localized', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Locally Advanced', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Metastatic', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Not Classifiable', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'FAS. Prostate cancer stage was classified according to the Tumor, Nodes, and Metastatic (TNM) scale to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor. The majority of participants did not have their prostate cancer classified for the complete TNM scale (17 participants) or were known for having metastatic prostate cancer (14 participants).', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'whyStopped': 'Poor recruitment due to rare targeted population', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-18', 'studyFirstSubmitDate': '2009-01-27', 'resultsFirstSubmitDate': '2011-06-14', 'studyFirstSubmitQcDate': '2009-01-27', 'lastUpdatePostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-28', 'studyFirstPostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12', 'timeFrame': 'After treatment of 12 weeks compared to Baseline', 'description': 'The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total IPSS at Weeks 4 and 8', 'timeFrame': 'After treatment of 4 and 8 weeks compared to Baseline', 'description': 'The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.'}, {'measure': 'Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit', 'timeFrame': 'After treatment of 4, 8 and 12 weeks compared to Baseline', 'description': 'Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)'}, {'measure': 'Change From Baseline in Residual Volume (Vresidual) at Each Visit', 'timeFrame': 'After treatment of 4, 8 and 12 weeks compared to Baseline', 'description': 'Uroflowmetry was used to quantify the residual volume (Vresidual; mL)'}, {'measure': 'Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12', 'timeFrame': 'After 12 weeks treatment compared to Baseline', 'description': 'TRUS is a method of measuring the size of the prostate.'}, {'measure': 'Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit', 'timeFrame': 'After treatment of 4, 8 and 12 weeks compared to Baseline'}, {'measure': 'Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit', 'timeFrame': 'After treatment of 4, 8 and 12 weeks compared to Baseline'}, {'measure': 'Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit', 'timeFrame': 'After treatment of 4, 8 and 12 weeks compared to Baseline', 'description': "The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL."}, {'measure': 'Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight', 'timeFrame': 'Baseline to 12 weeks of treatment', 'description': '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.'}, {'measure': 'Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables', 'timeFrame': 'Baseline to 12 weeks of treatment', 'description': 'The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least on participant with one abnormal value are presented, many more variables were included in the trial.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '23258223', 'type': 'RESULT', 'citation': 'Anderson J, Al-Ali G, Wirth M, Gual JB, Gomez Veiga F, Colli E, van der Meulen E, Persson BE. Degarelix versus goserelin (+ antiandrogen flare protection) in the relief of lower urinary tract symptoms secondary to prostate cancer: results from a phase IIIb study (NCT00831233). Urol Int. 2013;90(3):321-8. doi: 10.1159/000345423. Epub 2012 Dec 15.'}, {'pmid': '34350976', 'type': 'DERIVED', 'citation': 'Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients.\n\nPatients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has given written informed consent before any trial-related activity is performed\n* Has a confirmed prostate cancer in which this type of treatment is needed.\n\nExclusion Criteria:\n\n* Previous treatment for prostate cancer\n* Previous trans-urethral resection of the prostate\n* Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.\n* Patients in need of external beam radiotherapy to be started at the same time as hormone therapy\n* Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)\n* History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.\n* Hypersensitivity towards any component of the investigational product\n* Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.\n* Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.'}, 'identificationModule': {'nctId': 'NCT00831233', 'briefTitle': 'Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Reduction in International Prostate Symptom Score (IPSS), in Patients With Lower Urinary Tract Symptoms (LUTS) Secondary to Locally Advanced Prostate Cancer', 'orgStudyIdInfo': {'id': 'FE200486 CS28'}, 'secondaryIdInfos': [{'id': '2008-004338-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Degarelix 240 mg/80 mg', 'description': 'Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)', 'interventionNames': ['Drug: Degarelix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Goserelin (3.6 mg) + bicalutamide (50 mg)', 'description': 'Goserelin (3.6 mg) + bicalutamide (50 mg)', 'interventionNames': ['Drug: Goserelin', 'Drug: Bicalutamide']}], 'interventions': [{'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['FE200486'], 'description': 'The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.', 'armGroupLabels': ['Degarelix 240 mg/80 mg']}, {'name': 'Goserelin', 'type': 'DRUG', 'otherNames': ['Zoladex'], 'description': 'Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The second and third doses of goserelin were administered on Days 31 and 59, respectively.', 'armGroupLabels': ['Goserelin (3.6 mg) + bicalutamide (50 mg)']}, {'name': 'Bicalutamide', 'type': 'DRUG', 'otherNames': ['Casodex'], 'description': 'On Day 0, three days before the first dose of goserelin on Day 3, patients began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin.', 'armGroupLabels': ['Goserelin (3.6 mg) + bicalutamide (50 mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96047', 'city': 'Bamberg', 'country': 'Germany', 'facility': 'Facharztpraxis für Urologie', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'zip': '46325', 'city': 'Borken', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis', 'geoPoint': {'lat': 51.84382, 'lon': 6.85774}}, {'zip': '50667', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '90763', 'city': 'Fürth', 'country': 'Germany', 'facility': 'Euromed Clinic', 'geoPoint': {'lat': 49.47593, 'lon': 10.98856}}, {'zip': '22399', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Urologische Gemeinschaftspraxis', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '04109', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'VITURO Gesellschaft für Klinische Studien', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '63069', 'city': 'Offenbach', 'country': 'Germany', 'facility': 'Klinikum Offenbach GmbH', 'geoPoint': {'lat': 50.10061, 'lon': 8.76647}}, {'zip': '82152', 'city': 'Planegg', 'country': 'Germany', 'facility': 'Urologische Klinik Planegg', 'geoPoint': {'lat': 48.10672, 'lon': 11.42483}}, {'zip': '42103', 'city': 'Wuppertal', 'country': 'Germany', 'facility': 'Wuppertaler Gemeinschaftspraxis', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'city': 'A Coruña', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '28805', 'city': 'Alcalá de Henares-Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Principe de Asturias'}, {'zip': '28922', 'city': 'Alcorcón', 'country': 'Spain', 'facility': 'Fundacion Hospital Alcorcón', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Fundación Puigvert', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '48013', 'city': 'Bilbao (Bizkaia)', 'country': 'Spain', 'facility': 'Hospital de Basurto', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario S. 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