Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-29 @ 4:20 PM
Study NCT ID:
NCT00663858
Status:
COMPLETED
Last Update Posted:
2011-01-17
First Post:
2008-04-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'HSindermann@aezsinc.com', 'phone': '+49 69 42602 3429', 'title': 'Herbert Sindermann', 'organization': 'Aeterna Zentaris'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cetrorelix 78+78', 'description': '78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)', 'otherNumAtRisk': 212, 'otherNumAffected': 10, 'seriousNumAtRisk': 212, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'CET 78+Placebo', 'description': '78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.', 'otherNumAtRisk': 106, 'otherNumAffected': 5, 'seriousNumAtRisk': 106, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo on Week 0, 2, 26 and 28.', 'otherNumAtRisk': 102, 'otherNumAffected': 6, 'seriousNumAtRisk': 102, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cystitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Herpes zoster ophtalmic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Intervertebral disc protusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Myocardial infartion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 10.1'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'International Prostate Symptom Score (IPSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetrorelix 78+78', 'description': '78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)'}, {'id': 'OG001', 'title': 'CET 78+Placebo', 'description': '78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo on Week 0, 2, 26 and 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.2', 'spread': '5.68', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '5.18', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '6.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.371', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.592', 'ciLowerLimit': '-1.894', 'ciUpperLimit': '0.709', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.662', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3253', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.711', 'ciLowerLimit': '-0709', 'ciUpperLimit': '2.132', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.722', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0333', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.324', 'ciLowerLimit': '-2.542', 'ciUpperLimit': '-0.106', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.620', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 weeks', 'description': 'IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total overall score range: 0 points (best) to 35 points (worst)', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cetrorelix 78+78', 'description': '78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)'}, {'id': 'FG001', 'title': 'CET 78+Placebo', 'description': '78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo on Week 0, 2, 26 and 28.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '106'}, {'groupId': 'FG002', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '420', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cetrorelix 78+78', 'description': '78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)'}, {'id': 'BG001', 'title': 'CET 78+Placebo', 'description': '78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo on Week 0, 2, 26 and 28.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '183', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '237', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.58', 'spread': '8.16', 'groupId': 'BG000'}, {'value': '66.50', 'spread': '7.29', 'groupId': 'BG001'}, {'value': '67.72', 'spread': '7.17', 'groupId': 'BG002'}, {'value': '66.83', 'spread': '7.71', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '420', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Belarus', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}, {'title': 'Macedonia, The Former Yugoslav Republic of', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-15', 'studyFirstSubmitDate': '2008-04-17', 'resultsFirstSubmitDate': '2010-11-11', 'studyFirstSubmitQcDate': '2008-04-17', 'lastUpdatePostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-15', 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Prostate Symptom Score (IPSS)', 'timeFrame': 'Baseline and 52 weeks', 'description': 'IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total overall score range: 0 points (best) to 35 points (worst)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Benign Prostatic Hypertrophy']}, 'descriptionModule': {'briefSummary': "Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.\n\nFor this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90)."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Benign Prostatic Hyperplasia, based on medical history\n* Voiding symptoms\n\nExclusion Criteria:\n\n* Urgent need for prostate surgery or prior surgical treatment of the prostate or bladder\n* Major organ dysfunction\n* Eczema (atopic dermatitis) treated during the last 6 months\n* Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior randomization or with α blockers or saw palmetto within the last 6 weeks prior to randomization\n* Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy\n* History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months'}, 'identificationModule': {'nctId': 'NCT00663858', 'briefTitle': 'Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AEterna Zentaris'}, 'officialTitle': 'Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-blind Placebo-controlled Efficacy Study', 'orgStudyIdInfo': {'id': 'AEZS-102-036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cetrorelix 78+78', 'interventionNames': ['Drug: Cetrorelix 78+78']}, {'type': 'EXPERIMENTAL', 'label': 'Cetrorelix 78 + Placebo', 'interventionNames': ['Drug: Cetrorelix 78 + Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Cetrorelix 78+78', 'type': 'DRUG', 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