Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT01777269
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2013-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prospective Sexual Function Study for BPH Subjects
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': 'D000068538', 'term': 'Dutasteride'}, {'id': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D001378', 'term': 'Azasteroids'}, {'id': 'D013260', 'term': 'Steroids, Heterocyclic'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to approximately 18 months).', 'description': 'On-treatment SAEs and non-serious AEs are reported for ITT Population.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months', 'otherNumAtRisk': 246, 'otherNumAffected': 28, 'seriousNumAtRisk': 246, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months', 'otherNumAtRisk': 243, 'otherNumAffected': 66, 'seriousNumAtRisk': 243, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Retrograde ejaculation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ejaculation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Infected cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebrospinal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thalamic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pelvi-ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Testicular cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months", 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months'}, {'id': 'OG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.00', 'ciLowerLimit': '-10.22', 'ciUpperLimit': '-5.79', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'Total MSHQ score is composed of 3 domain scores: Erection score(ES)=sum of score for Questions (Q) 1 to 3(ranges from 0 to 15), Ejaculation score(EjS)=sum of scores for Q5 to 11(ranges from 1 to 35), Satisfaction score(SS)=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS. The total MSHQ score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analyzed using a mixed model repeated measures (MMRM) analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest double-blind (DB) treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT): All randomized par. regardless of whether or not treatment was administered. Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles).'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months", 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months'}, {'id': 'OG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months'}], 'classes': [{'title': 'Month 1, n=193, 192', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, n= 184, 181', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Month 6, n=179, 164', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-9.9', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Month 9, n=166, 146', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-9.6', 'spread': '0.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.11', 'ciLowerLimit': '-6.01', 'ciUpperLimit': '-2.21', 'estimateComment': 'Month 1', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.43', 'ciLowerLimit': '-8.45', 'ciUpperLimit': '-4.41', 'estimateComment': 'Month 3', 'statisticalMethod': 'Adjusted mean difference', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.04', 'ciLowerLimit': '-11.31', 'ciUpperLimit': '-6.77', 'estimateComment': 'Month 6', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.82', 'ciLowerLimit': '-10.96', 'ciUpperLimit': '-6.67', 'estimateComment': 'Month 9', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 1, 3, 6, and 9', 'description': 'Total MSHQ score is composed of 3 domain scores: ES=sum of score for Q 1 to 3(ranges from 0 to 15), EjS=sum of scores for Q5 to 11(ranges from 1 to 35), SS=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analysed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months'}, {'id': 'OG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months'}], 'classes': [{'title': '>= 25', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '>= 20', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '>= 10', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '<= -25', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '<= -20', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '<= -10', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 months', 'description': 'Participants reaching thresholds of change in total MSHQ were assessed. Threshold values are defined as multiplicative factor. Threshold included +10 points, +20 points, +25 points, -10 points, -20 points, -25 points; where "+" indicates improvement and "-"indicates worsening. Treatment comparisons were done based on categories defined by these thresholds using Mantel-Haenszel test', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months'}, {'id': 'OG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months'}], 'classes': [{'title': 'Month 1, n=209, 215', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, n= 202, 208', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Month 6, n= 193, 188', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Month 9, n=182, 169', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Month 12, n= 175, 168', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.23', 'estimateComment': 'Month 1', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.24', 'estimateComment': 'Month 3', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '0.15', 'estimateComment': 'Month 6', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '-0.17', 'estimateComment': 'Month 9', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '0.07', 'estimateComment': 'Month 12', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 1, 3, 6, 9 and 12', 'description': 'Erection scale is a domain of MSHQ to assess erectile dysfunction. ES is the sum of score for questions 1 to 3. The score ranges from 0 (no erection) to 15 (strong erection). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months'}, {'id': 'OG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months'}], 'classes': [{'title': 'Month 1, n=210, 208', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, n= 197, 196', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'Month 6, n= 191, 179', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'Month 9, n=177, 161', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Month 12, n= 173, 164', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '0.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.89', 'ciLowerLimit': '-4.07', 'ciUpperLimit': '-1.70', 'estimateComment': 'Month 1', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.24', 'ciLowerLimit': '-6.59', 'ciUpperLimit': '-3.90', 'estimateComment': 'Month 3', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.82', 'ciLowerLimit': '-8.30', 'ciUpperLimit': '-5.34', 'estimateComment': 'Month 6', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.05', 'ciLowerLimit': '-8.51', 'ciUpperLimit': '-5.59', 'estimateComment': 'Month 9', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.92', 'ciLowerLimit': '-8.47', 'ciUpperLimit': '-5.38', 'estimateComment': 'Month 12', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 1, 3, 6, 9 and 12', 'description': 'Ejaculation scale is a domain of MSHQ to assess ejaculatory dysfunction. EjS is the sum of score for questions 5 to 11. The score ranges from 1 (could not ejaculate) to 35 (strong ejaculation). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months'}, {'id': 'OG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months'}], 'classes': [{'title': 'Month 1, n=200, 197', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, n= 189, 182', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Month 6, n= 185, 168', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Month 9, n=173, 153', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Month 12, n= 169, 152', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.94', 'ciLowerLimit': '-1.67', 'ciUpperLimit': '-0.21', 'estimateComment': 'Month 1', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.93', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '-0.17', 'estimateComment': 'Month 3', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.73', 'ciLowerLimit': '-2.57', 'ciUpperLimit': '-0.88', 'estimateComment': 'Month 6', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.15', 'ciLowerLimit': '-2.01', 'ciUpperLimit': '-0.30', 'estimateComment': 'Month 9', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-1.65', 'ciUpperLimit': '-0.01', 'estimateComment': 'Month 12', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 1, 3, 6, 9 and 12', 'description': 'Satisfaction scale is a domain of MSHQ to assess sexual relationship. SS is the sum of score for questions 13 to 18. The score ranges from 6 (extremely dissatisfied) to 30 (extremely satisfied). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) Scores Using the Observed Cases Approach at 2 Weeks, 1, 3, 6, 9, and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months'}, {'id': 'OG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months'}], 'classes': [{'title': 'Week 2, n=232, 234', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Month1, n=222, 231', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, n=217, 224', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Month 6, n=206, 203', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'Month 9, n=193, 185', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Month 12, n=187, 184', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.65', 'ciLowerLimit': '-2.45', 'ciUpperLimit': '-0.85', 'estimateComment': 'Week 2', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '0.37', 'estimateComment': 'Month 1', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.27', 'ciLowerLimit': '-2.19', 'ciUpperLimit': '-0.36', 'estimateComment': 'Month 3', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.73', 'ciLowerLimit': '-2.74', 'ciUpperLimit': '-0.72', 'estimateComment': 'Month 6', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.34', 'ciLowerLimit': '-2.40', 'ciUpperLimit': '-0.28', 'estimateComment': 'Month 9', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.97', 'ciLowerLimit': '-3.12', 'ciUpperLimit': '-0.83', 'estimateComment': 'Month 12', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 1, 3, 6, 9 and 12', 'description': 'The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify urinary symptoms: Q1, incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. The score can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months'}, {'id': 'OG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months'}], 'classes': [{'title': 'Week 2, n=226, 227', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Month1, n=216, 223', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, n=211, 217', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Month 6, n=201, 195', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Month 9, n=188, 179', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Month 12, n=183, 177', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '-0.03', 'estimateComment': 'Week 2', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.37', 'estimateComment': 'Month 1', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.15', 'estimateComment': 'Month 3', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '-0.15', 'estimateComment': 'Month 6', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.056', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '0.01', 'estimateComment': 'Month 9', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '-0.08', 'estimateComment': 'Month 12', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 1, 3, 6, 9 and 12', 'description': 'The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating the impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Perception of Treatment Benefit/Satisfaction With Treatment (Patient Perception of Study Medication - PPSM Questionnaire Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months'}, {'id': 'OG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months'}], 'classes': [{'title': 'Week 2, n=225, 227', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Month1, n=216, 223', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, n=211, 217', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '0.41', 'groupId': 'OG001'}]}]}, {'title': 'Month 6, n=201, 195', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Month 9, n=188, 179', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'Month 12, n=182, 177', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '0.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.00', 'ciLowerLimit': '-3.89', 'ciUpperLimit': '-2.10', 'estimateComment': 'Week 2', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.10', 'ciLowerLimit': '-3.15', 'ciUpperLimit': '-1.06', 'estimateComment': 'Month 1', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.11', 'ciLowerLimit': '-3.25', 'ciUpperLimit': '-0.98', 'estimateComment': 'Month 3', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.53', 'ciLowerLimit': '-3.76', 'ciUpperLimit': '-1.30', 'estimateComment': 'Month 6', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.30', 'ciLowerLimit': '-2.56', 'ciUpperLimit': '-0.05', 'estimateComment': 'Month 9', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.51', 'ciLowerLimit': '-4.87', 'ciUpperLimit': '-2.14', 'estimateComment': 'Month 12', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Month 1, 3, 6, 9 and 12', 'description': "Patient Perception of Study Medication (PPSM) is a 12-item questionnaire designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms. The total PPSM score ranges from 7 to 49, with higher scores indicating lower satisfaction. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9, 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months'}, {'id': 'OG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months'}], 'classes': [{'title': 'IPSS improvement of >=2, n=152, 142', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'IPSS improvement of >=3, n=138,136', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '0.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.78', 'ciLowerLimit': '-10.07', 'ciUpperLimit': '-5.49', 'estimateComment': 'Par. with IPSS change from baseline \\>=2 points improvement at any time post-baseline visit', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.39', 'ciLowerLimit': '-9.79', 'ciUpperLimit': '-4.99', 'estimateComment': 'Par. with IPSS change from baseline \\>=3 points improvement at any time post-baseline visit', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Total MSHQ score is composed of 3 domain scores: ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Par. with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed. Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months'}, {'id': 'OG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.79', 'ciLowerLimit': '-10.22', 'ciUpperLimit': '-5.35', 'estimateComment': 'Par. with IPSS change from baseline \\>=25 points improvement at any time post-baseline visit', 'statisticalMethod': 'mixed-model repeated-measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Participants with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed.Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months'}, {'id': 'FG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 milligrams (mg) and tamsulosin 0.4 mg plus lifestyle advice for 12 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}, {'groupId': 'FG001', 'numSubjects': '243'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}, {'groupId': 'FG001', 'numSubjects': '184'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '59'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Participants reached stopping criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'This is a European double-blind, placebo-controlled, parallel-group study to assess the impact of dutasteride treatment on sexual function in men with moderate/severe Benign Prostatic Hyperplasia (BPH)', 'preAssignmentDetails': 'Eligible participants (par.) entered a 4-week Placebo Run-in Phase, and were randomised in 1:1 ratio to receive DUODART (fixed dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg) and placebo one capsule daily for 52 weeks. Follow-up was performed 6 months after the last dose of study medication'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '489', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received a matching placebo for Duodart plus lifestyle advice for 12 months'}, {'id': 'BG001', 'title': 'Duodart', 'description': 'Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'spread': '6.49', 'groupId': 'BG000'}, {'value': '65.7', 'spread': '6.59', 'groupId': 'BG001'}, {'value': '65.5', 'spread': '6.53', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Male', 'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '489', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White - Arabic/North African Heritage', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'White - White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '239', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '476', 'groupId': 'BG002'}]}]}, {'title': 'Mixed Race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 489}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-20', 'studyFirstSubmitDate': '2013-01-24', 'resultsFirstSubmitDate': '2016-11-15', 'studyFirstSubmitQcDate': '2013-01-24', 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-17', 'studyFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months", 'timeFrame': 'Baseline and 12 months', 'description': 'Total MSHQ score is composed of 3 domain scores: Erection score(ES)=sum of score for Questions (Q) 1 to 3(ranges from 0 to 15), Ejaculation score(EjS)=sum of scores for Q5 to 11(ranges from 1 to 35), Satisfaction score(SS)=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS. The total MSHQ score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analyzed using a mixed model repeated measures (MMRM) analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest double-blind (DB) treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s)'}], 'secondaryOutcomes': [{'measure': "Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months", 'timeFrame': 'Baseline and Month 1, 3, 6, and 9', 'description': 'Total MSHQ score is composed of 3 domain scores: ES=sum of score for Q 1 to 3(ranges from 0 to 15), EjS=sum of scores for Q5 to 11(ranges from 1 to 35), SS=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analysed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)'}, {'measure': 'Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months', 'timeFrame': 'Baseline and 12 months', 'description': 'Participants reaching thresholds of change in total MSHQ were assessed. Threshold values are defined as multiplicative factor. Threshold included +10 points, +20 points, +25 points, -10 points, -20 points, -25 points; where "+" indicates improvement and "-"indicates worsening. Treatment comparisons were done based on categories defined by these thresholds using Mantel-Haenszel test'}, {'measure': 'Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months', 'timeFrame': 'Baseline and Month 1, 3, 6, 9 and 12', 'description': 'Erection scale is a domain of MSHQ to assess erectile dysfunction. ES is the sum of score for questions 1 to 3. The score ranges from 0 (no erection) to 15 (strong erection). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)'}, {'measure': 'Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months', 'timeFrame': 'Baseline and Month 1, 3, 6, 9 and 12', 'description': 'Ejaculation scale is a domain of MSHQ to assess ejaculatory dysfunction. EjS is the sum of score for questions 5 to 11. The score ranges from 1 (could not ejaculate) to 35 (strong ejaculation). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)'}, {'measure': 'Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months', 'timeFrame': 'Baseline and Month 1, 3, 6, 9 and 12', 'description': 'Satisfaction scale is a domain of MSHQ to assess sexual relationship. SS is the sum of score for questions 13 to 18. The score ranges from 6 (extremely dissatisfied) to 30 (extremely satisfied). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)'}, {'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) Scores Using the Observed Cases Approach at 2 Weeks, 1, 3, 6, 9, and 12 Months', 'timeFrame': 'Baseline and Month 1, 3, 6, 9 and 12', 'description': 'The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify urinary symptoms: Q1, incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. The score can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)'}, {'measure': 'Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months', 'timeFrame': 'Baseline and Month 1, 3, 6, 9 and 12', 'description': 'The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating the impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)'}, {'measure': 'Change From Baseline in Perception of Treatment Benefit/Satisfaction With Treatment (Patient Perception of Study Medication - PPSM Questionnaire Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months', 'timeFrame': 'Baseline, Week 2, Month 1, 3, 6, 9 and 12', 'description': "Patient Perception of Study Medication (PPSM) is a 12-item questionnaire designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms. The total PPSM score ranges from 7 to 49, with higher scores indicating lower satisfaction. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9, 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)"}, {'measure': 'Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points', 'timeFrame': 'Baseline and Month 12', 'description': 'Total MSHQ score is composed of 3 domain scores: ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Par. with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed. Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)'}, {'measure': 'Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent', 'timeFrame': 'Baseline and Month 12', 'description': 'Participants with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed.Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '29044968', 'type': 'DERIVED', 'citation': 'Roehrborn CG, Manyak MJ, Palacios-Moreno JM, Wilson TH, Roos EPM, Santos JC, Karanastasis D, Plastino J, Giuliano F, Rosen RC. A prospective randomised placebo-controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int. 2018 Apr;121(4):647-658. doi: 10.1111/bju.14057. Epub 2017 Nov 16.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudydatarequest.com', 'label': 'IPD for this study will be made available via the Clinical Study Data Request site.'}]}, 'descriptionModule': {'briefSummary': 'This is an European double-blind, placebo controlled parallel group comparison of DUODART (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and placebo.\n\nPRIMARY OBJECTIVE:\n\nTo assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH who are treated with DUODART, compared to men treated with placebo .', 'detailedDescription': "This is an European double-blind, placebo controlled parallel group comparison of DUODART (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and placebo. Men eligible at screening will be randomised, after a 4 week placebo run-in, to the 2 treatment groups in a 1:1 ratio. All men will receive standardised lifestyle advice (primarily concerning weight management and exercise) relevant to maintaining sexual function. Men will also receive a standardised lifestyle advice leaflet for BPH. The double blind phase will continue for 12 months, with assessment visits at 2 weeks and at months 1, 3, 6, 9 and a final visit at month 12. Subjects with sexual adverse events during the double blind phase will continue to be followed at scheduled study visits until resolution of the adverse event or at a visit 6 months after the last dose of study medication, whichever is sooner.\n\nPRIMARY OBJECTIVE:\n\nTo assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH (international prostate symptom score - IPSS = or \\> 12) who are treated with DUODART, compared to men treated with placebo . Change in sexual function will be assessed by change in total score from the full men's sexual health questionnaire (MSHQ) which has domains for erectile dysfunction, ejaculatory function and libido."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males aged ≥50 years.\n* Men must be sexually active. A man is considered sexually active if he has been engaged in sexual activity with a partner during the past 4 weeks (at least once) and plans to be active during the next 4 weeks (unless due to travel or other practical reasons). Men should confirm that they are in a stable relationship and expect to maintain their sexual activity over the next year.\n* A confirmed clinical diagnosis of BPH.\n* International Prostate Symptom Score (IPSS) ≥12 at Visit 1 (screening), with bother score 4 or less (score from the IPSS Quality of Life question 8).\n* Prostate volume ≥30 cc (by transrectal ultrasonography; TRUS). Measurement should be available by the baseline visit and should have been made /arranged at the screening visit or within the previous 6 months.\n* Total serum prostate specific antigen (PSA ≥1.5 ng/mL (see exclusion criteria 1) at Visit 1 (screening).\n* Willing and able to give signed written informed consent and comply with study procedures, including the ability to participate in the study for the full 1 year (or 18 months if necessary because of a persistent sexual AE).\n* Fluent and literate in local language with the ability to read, comprehend and record information on the MSHQ, IPSS, PPSM, BPH Impact Index (BII) and C-SSRS questionnaires.\n* Able to swallow and retain oral medication.\n* Men with a female partner of childbearing potential must either agree to use effective contraception or have had a prior vasectomy. Contraception must be used from 2 weeks prior to administration of the first dose of study treatment until at least 5 half-lives for the drug (45 days) plus 3 months (i.e. a total of 4.5 months) to allow clearance of any altered sperm after the last dose of study treatment.\n* French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.\n\nExclusion Criteria:\n\n* Total serum PSA \\>10.0 ng/mL at Visit 1 (screening).\n* History or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE and/or rising PSA). Subjects with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.\n\nNote: If total serum PSA is \\>4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, including consideration of prostate biopsy.\n\nExcluded medication and therapies\n\n* Current or prior use (within the periods given) of the following prohibited medications\n* Any prior use of a 5α-reductase inhibitor (finasteride or dutasteride),\n* Anti-cholinergics (e.g. oxybutynin, propantheline, tolerodine, solifenacin or darifenacin) within 1 month prior to visit 2 (baseline)\n* An alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 1 month prior to visit 2 (baseline)\n* Use of any drugs with anti-androgenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents) within the 6 months prior to visit 1 (screening).\n* Use of any drugs noted for propensity to cause gynaecomastia, or which could affect prostate volume, within 6 months prior to Visit 1 (screening).\n* Use of any investigational or marketed study drug within 30 days or 5 half-lives of the drug in question, (whichever is longer), preceding visit 2 (baseline).\n* Current use (at the baseline visit or within the prior 1month) of:\n* PDE-5 inhibitors for Erectile Dysfunction.\n* Anabolic steroids.\n* Drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin.\n* Use of phytotherapy for BPH within 2 weeks prior to Visit 1 (screening) and/or predicted to need phytotherapy during the study.\n* History of a known (immediate or delayed) hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to the study medication or excipients that, in the opinion of the Investigator or GSK, contraindicate their participation.\n* Previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive or minimally invasive procedures to treat BPH.\n\nRecent Medical Procedures\n\n\\- History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to Visit 1 (screening). Catheterisation (\\<10F) is acceptable with no time restriction.\n\nMedical history\n\n* Presence of structural abnormalities in the Lower Urinary Tract or sexual organs (e.g. urethral stricture, Peyronie's Disease etc) that may cause LUTS or sexual dysfunction.\n* History of AUR.\n* Post-void residual volume \\>100 mL (suprapubic ultrasound) at Visit 1 (screening) or a recorded PVR above this level on any previous examination. Measurement should be available by the baseline visit and should have been made /arranged at the screening visit or within the previous 6 months.\n* Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections).\n* History of 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy.\n* History of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.\n* History of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy.\n* Prior history of malignancies (other than basal cell carcinoma or squamous cell carcinoma of the skin) within the past 5 years. Subjects with an earlier history of malignancy who have had no evidence of disease for at least the past 5 years are eligible.\n* History of hepatic impairment or abnormal liver function tests at Visit 1 (screening) (defined as ALT, AST or alkaline phosphatase \\>2 times the ULN, or total bilirubin \\>1.5 times the ULN (unless associated with predominantly indirect bilirubin elevation or Gilbert's syndrome).\n* History of renal insufficiency, or serum creatinine \\>1.5 times the upper limit of normal at Visit 1 (screening).\n* Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to the Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.\n* History or current evidence of drug or alcohol abuse within the previous 12 months.\n* History or presence of any serious and/or unstable pre-existing psychiatric disorder or other conditions that in the opinion of the Investigator or GSK Medical Monitor, could interfere with subject's safety, obtaining informed consent, compliance to the study procedures, or confound the results of the study."}, 'identificationModule': {'nctId': 'NCT01777269', 'briefTitle': 'Prospective Sexual Function Study for BPH Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Prospective Study of Sexual Function in Sexually Active Men Treated for BPH', 'orgStudyIdInfo': {'id': '116115'}, 'secondaryIdInfos': [{'id': '2012-002047-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duodart', 'description': 'Fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg. A capsule once daily during 12 months', 'interventionNames': ['Drug: Dutasteride plus tamsulosin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar Pill', 'description': 'A capsule once daily during 12 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dutasteride plus tamsulosin', 'type': 'DRUG', 'description': 'Take 1 capsule daily', 'armGroupLabels': ['Duodart']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Take one capsule daily', 'armGroupLabels': ['Sugar Pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2076', 'city': 'Wahroonga', 'state': 'New South Wales', 'country': 'Australia', 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