Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-25 @ 12:55 AM
Study NCT ID:
NCT00449150
Status:
TERMINATED
Last Update Posted:
2018-08-03
First Post:
2007-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cetrorelix (CET) Pamoate Regimens 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C062876', 'term': 'cetrorelix'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DCroteau@aezsinc.com', 'phone': '418-652-7669', 'title': 'Daniel Croteau, Medical Manager', 'phoneExt': '272', 'organization': 'AEterna Zentaris'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks.', 'description': 'For severity grading, the following definitions will be used:\n\n* Grade 1 - Mild: awareness of sign, symptom, or event, but easily tolerated\n* Grade 2 - Moderate: discomfort enough to cause interference usual activity and may warrant intervention\n* Grade 3 - Severe: incapacitating with inability to do usual activities or significantly affects clinical status and warrants intervention\n\nA special attention will be given to assess the severity of hot flashes.', 'eventGroups': [{'id': 'EG000', 'title': 'Cetrorelix 78+78', 'description': '78+78 means 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': 219, 'otherNumAffected': 177, 'seriousNumAtRisk': 219, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Cetrorelix 78+52', 'description': '78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)', 'otherNumAtRisk': 230, 'otherNumAffected': 179, 'seriousNumAtRisk': 230, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo on Week 0, 2 26 and 28', 'otherNumAtRisk': 218, 'otherNumAffected': 169, 'seriousNumAtRisk': 218, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'ALT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hot flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hypecholesterolemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'PSA increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'IIIrd nerve paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'carbon monoxide poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'cellulitis of legs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'dislocation of joint prosthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'gastrointestinal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'implant site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'mood disorder due to a general medical condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'muscle contractions involuntary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'vascular headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'vocal cord paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'International Prostate Symptoms Score (IPSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '213', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetrorelix 78+78', 'description': '78+78 means 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': 'Cetrorelix 78+52', 'description': '78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo on Week 0, 2 26 and 28'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'spread': '6.61', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '5.90', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '6.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.7424', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS means estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.198', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '0.98', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.926', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS means estimate', 'ciPctValue': '95', 'paramValue': '0.055', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '1.21', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6699', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS means estimate', 'ciPctValue': '95', 'paramValue': '-0.252', 'ciLowerLimit': '-1.41', 'ciUpperLimit': '0.91', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 weeks', 'description': 'The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated 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 range: 0 points (best) to 35 points (worst)', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-treat (ITT) population included all participants for whom at least one post-baseline efficacy assessment was available; imputation per Last Observation Carried Forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Time Course of Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group A: Cetrorelix (CET) 78 mg + 78 mg', 'description': 'Treatment course 1: Cetrorelix 78 mg + 78 mg\n\n* Week 0: 52 mg CET (2 injections)\n* Week 2: 26 mg CET (1 injection)\n\nTreatment course 2:\n\n* Week 26: 52 mg CET (2 injections)\n* Week 28: 26 mg CET(1 injection)\n\n 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.\n\nCetrorelix 78 mg + 78 mg'}, {'id': 'OG001', 'title': 'Treatment Group B: CET 78 mg + 52 mg', 'description': 'Treatment course 1: Cetrorelix 78 mg + 52 mg\n\n* Week 0: 52 mg CET (2 injections)\n* Week 2: 26 mg CET (1 injection)\n\nTreatment course 2:\n\n* Week 26: 52 mg CET (2 injections)\n* Week 28: Placebo (1 injection)\n\n 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.\n\nCetrorelix 78 mg + 52 mg\n\nPlacebo'}, {'id': 'OG002', 'title': 'Treatment Group C: Placebo', 'description': 'Treatment course 1:\n\n* Week 0: placebo (2 injections)\n* Week 2: placebo (1 injection)\n\nTreatment course 2:\n\n* Week 26: placebo (2 injections)\n* Week 28: placebo (1 injection)\n\n 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.\n\nPlacebo'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '-0.35', 'spread': '1.00', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '-0.47', 'spread': '1.05', 'groupId': 'OG002'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '-0.48', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '-0.46', 'spread': '1.07', 'groupId': 'OG002'}]}]}, {'title': 'Week 30', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '1.24', 'groupId': 'OG002'}]}]}, {'title': 'Week 38', 'categories': [{'measurements': [{'value': '-0.62', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '-0.59', 'spread': '1.22', 'groupId': 'OG002'}]}]}, {'title': 'Week 46', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '1.39', 'groupId': 'OG001'}, {'value': '-0.60', 'spread': '1.11', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Quality of life assessment in the following weeks: 4,12,26,30,38,46,52', 'description': 'The time course of quality of life: assessed by the following disease specific quality of life:"If you were to spend the rest of your life with the urinary conditions just the way it is now, how would you feel about that?" The rating scale is comprising a range of values from 0 to 6, with = delighted, 1 = pleased, 2 = mostly satisfied, 3 = mixed, 4 = mostly dissatisfied, 5 = unhappy, 6 = terrible.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cetrorelix 78+78', 'description': '78+78 means 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': 'Cetrorelix 78+52', 'description': '78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo on Week 0, 2 26 and 28'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}, {'groupId': 'FG001', 'numSubjects': '230'}, {'groupId': 'FG002', 'numSubjects': '218'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Subjects could have more than one reason for not completing.', 'groupId': 'FG000', 'numSubjects': '173'}, {'comment': 'Subjects could have more than one reason for not completing.', 'groupId': 'FG001', 'numSubjects': '177'}, {'comment': 'Subjects could have more than one reason for not completing.', 'groupId': 'FG002', 'numSubjects': '171'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}, {'value': '667', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cetrorelix 78+78', 'description': '78+78 means 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': 'Cetrorelix 78+52', 'description': '78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)'}, {'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': '109', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '346', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '321', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.86', 'spread': '8.27', 'groupId': 'BG000'}, {'value': '64.04', 'spread': '7.54', 'groupId': 'BG001'}, {'value': '64.20', 'spread': '7.76', 'groupId': 'BG002'}, {'value': '64.03', 'spread': '7.84', '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': '219', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}, {'value': '667', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '430', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 667}}, 'statusModule': {'whyStopped': 'Trial did not meet primary efficacy endpoint for double blind phase.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2007-03-15', 'resultsFirstSubmitDate': '2010-10-05', 'studyFirstSubmitQcDate': '2007-03-15', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-12-15', 'studyFirstPostDateStruct': {'date': '2007-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Prostate Symptoms Score (IPSS)', 'timeFrame': 'Baseline and 52 weeks', 'description': 'The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated 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 range: 0 points (best) to 35 points (worst)'}], 'secondaryOutcomes': [{'measure': 'Time Course of Quality of Life', 'timeFrame': 'Quality of life assessment in the following weeks: 4,12,26,30,38,46,52', 'description': 'The time course of quality of life: assessed by the following disease specific quality of life:"If you were to spend the rest of your life with the urinary conditions just the way it is now, how would you feel about that?" The rating scale is comprising a range of values from 0 to 6, with = delighted, 1 = pleased, 2 = mostly satisfied, 3 = mixed, 4 = mostly dissatisfied, 5 = unhappy, 6 = terrible.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cetrorelix'], '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).", 'detailedDescription': 'The objectives of the study are to develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in BPH-related signs and symptoms.\n\nPatients will enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS).\n\nPatients will then be allocated to study drug in a double-blind, randomized, double-dummy, placebo-controlled fashion.\n\nPatients will be administered an IM injection of study drug at Week 0, 2, 26 and 28 and will be followed up to Week 52.\n\nThen, in an open label fashion, patients will be administered an IM injection of study drug at Week 52, 54, 78 and 80 and will be followed up to Week 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': 'NCT00449150', 'briefTitle': 'Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AEterna Zentaris'}, 'officialTitle': 'Cetrorelix Pamoate Intermittent Intramuscular (IM) Dosage Regimens in Patients With Symptomatic BPH: a 1 Year Placebo-controlled Efficacy Study and Long-term Safety Assessment', 'orgStudyIdInfo': {'id': 'Z033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group A: CET 78 mg + 78 mg', 'description': 'Treatment course 1: Cetrorelix 78 mg + 78 mg\n\n* Week 0: 52 mg CET (2 injections)\n* Week 2: 26 mg CET (1 injection)\n\nTreatment course 2:\n\n* Week 26: 52 mg CET (2 injections)\n* Week 28: 26 mg CET(1 injection)\n\n 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.', 'interventionNames': ['Drug: Cetrorelix 78 mg + 78 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group B: CET 78 mg + 52 mg', 'description': 'Treatment course 1: Cetrorelix 78 mg + 52 mg\n\n* Week 0: 52 mg CET (2 injections)\n* Week 2: 26 mg CET (1 injection)\n\nTreatment course 2:\n\n* Week 26: 52 mg CET (2 injections)\n* Week 28: Placebo (1 injection)\n\n 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.', 'interventionNames': ['Drug: Cetrorelix 78 mg + 52 mg', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment Group C: Placebo', 'description': 'Treatment course 1:\n\n* Week 0: placebo (2 injections)\n* Week 2: placebo (1 injection)\n\nTreatment course 2:\n\n* Week 26: placebo (2 injections)\n* Week 28: placebo (1 injection)\n\n 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cetrorelix 78 mg + 78 mg', 'type': 'DRUG', 'otherNames': ['CET', 'AEZS-102'], 'armGroupLabels': ['Treatment Group A: CET 78 mg + 78 mg']}, {'name': 'Cetrorelix 78 mg + 52 mg', 'type': 'DRUG', 'otherNames': ['CET', 'AEZS-102'], 'armGroupLabels': ['Treatment Group B: CET 78 mg + 52 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo (PLA)'], 'armGroupLabels': ['Treatment Group B: CET 78 mg + 52 mg', 'Treatment Group C: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Medical Affiliated Research Center, Inc.', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '72901', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Urology Group of Westrn Arkansas', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'South Orange County Medical Research Center', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'California Professionnal Research', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'William G. Moseley', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Clinical Research', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Western Clinical Research, Inc.', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Urology Research Options', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045-0510', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Urologic Oncology', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Genitourinary Surgical Consultants', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06762', 'city': 'Middlebury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Clincal Research Center', 'geoPoint': {'lat': 41.52787, 'lon': -73.12761}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Medical Research', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa Bay Medical Research', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32114', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Atlantic Urological Associates', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '33125-1693', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami VACM', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Healthcare Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '34237', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Urologist Specialists', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Southeastern Research Group', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southwestern Medical Research Institute', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medecine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Welborn Clinic', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46825', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Northeast Indiana Research, LLC', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Urology Care', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '42003', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Four Rivers Clinical Research', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '20770', 'city': 'Greenbelt', 'state': 'Maryland', 'country': 'United States', 'facility': 'Myron I. Murdock M.D. LLC', 'geoPoint': {'lat': 39.00455, 'lon': -76.87553}}, {'zip': '48081', 'city': 'Saint Clair Shores', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Institute of Urology', 'geoPoint': {'lat': 42.49698, 'lon': -82.88881}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63136', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Metropolitan Urological Specialists', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Quality Clinical Research', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08060', 'city': 'Woodlane', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Delaware Valley Urology, LLC', 'geoPoint': {'lat': 40.01178, 'lon': -74.80155}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Urology Group Of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11706', 'city': 'Bay Shore', 'state': 'New York', 'country': 'United States', 'facility': 'Medical & Clinical Research Associates', 'geoPoint': {'lat': 40.7251, 'lon': -73.24539}}, {'zip': '11530', 'city': 'Garden City', 'state': 'New York', 'country': 'United States', 'facility': 'Urological Surgeons of Long Island, Clinical Research Division', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medecine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'University Urology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Hudson Valley Urology', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '28025', 'city': 'Concord', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Northeast Urology Research', 'geoPoint': {'lat': 35.40888, 'lon': -80.58158}}, {'zip': '73008', 'city': 'Bethany', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Parkhurst Research Oganization Inc.', 'geoPoint': {'lat': 35.51867, 'lon': -97.63226}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Urologic Research Center', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78404', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Corpus Christi Urology Group', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology Clinics of North Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390-9110', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center, Department of Urology', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Institute and the Texas Prostate Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology San Antonio Research, PA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98043', 'city': 'Mountlake Terrace', 'state': 'Washington', 'country': 'United States', 'facility': 'Integrity Medical Research', 'geoPoint': {'lat': 47.78815, 'lon': -122.30874}}, {'zip': '1756', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'National Oncological Hospital', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'V1Y 2H4', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Southern Interior Medical Research Inc.', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V3V 1N1', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Andreou Research Inc.', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V8T 5G1', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Can-Med Clinical Reserach Inc.', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'L4M 7G1', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Male / FemaleHealth and Research Center', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'K7L 3J7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Advanced Urological Research', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N2M 5N4', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Urologic Associates, Urologic Medical Research', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'P1B 7K8', 'city': 'North Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Canada Place Building', 'geoPoint': {'lat': 46.3168, 'lon': -79.46633}}, {'zip': 'L6H 3P1', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Fe/Male Health Centers', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6A 3B5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Male Health Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J4V 2H3', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Urology South Shore Research', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H2X 3J4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM, Hopital St-Luc', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H9R 3J1', 'city': 'Pointe-Claire', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Dynamik Research', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CRCEO', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '12627', 'city': 'Berlin', 'country': 'Germany', 'facility': 'ClinPharm International GmbH Prufzentrum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44787', 'city': 'Bochum', 'country': 'Germany', 'facility': 'ClinPharm International GmbH Prufzentrum Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '01067', 'city': 'Dresden', 'country': 'Germany', 'facility': 'ClinPharm International GmbH Prufzentrum Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '60596', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'ClinPharm International GmbH Prufzentrum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '02826', 'city': 'Görlitz', 'country': 'Germany', 'facility': 'ClinPharm International GmbH Prufzentrum Gorlitz', 'geoPoint': {'lat': 51.15518, 'lon': 14.98853}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'ClinPharm International GmbH Prufzentrum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '39104', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'ClinPharm International GmbH Prufzentrum Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}], 'overallOfficials': [{'name': 'Dr. Hebert Lepor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AEterna Zentaris', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}