Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT01130532
Status:
COMPLETED
Last Update Posted:
2013-01-04
First Post:
2010-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study in Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil', 'description': '2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.', 'otherNumAtRisk': 205, 'otherNumAffected': 46, 'seriousNumAtRisk': 205, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '5 mg Tadalafil', 'description': '5.0 mg Tadalafil for 12 weeks during double-blind treatment period.', 'otherNumAtRisk': 205, 'otherNumAffected': 68, 'seriousNumAtRisk': 205, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo for 12 weeks during double-blind treatment period.', 'otherNumAtRisk': 207, 'otherNumAffected': 50, 'seriousNumAtRisk': 207, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': '5 mg Tadalafil Open-Label Extension', 'description': '5 mg Tadalafil for 4 weeks during open-label treatment extension period.', 'otherNumAtRisk': 546, 'otherNumAffected': 23, 'seriousNumAtRisk': 546, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Suprapubic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 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'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tooth repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 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'seriousEvents': [{'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 546, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil (Period III)', 'description': '2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).'}, {'id': 'OG001', 'title': '5 mg Tadalafil (Period III)', 'description': '5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).'}, {'id': 'OG002', 'title': 'Placebo (Period III)', 'description': 'Placebo for 12 weeks during double-blind treatment period (Period III).'}], 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000'}, {'value': '39.6', 'groupId': 'OG001'}, {'value': '12.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 12 weeks', 'description': 'Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil (Period III)', 'description': '2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).'}, {'id': 'OG001', 'title': '5 mg Tadalafil (Period III)', 'description': '5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).'}, {'id': 'OG002', 'title': 'Placebo (Period III)', 'description': 'Placebo for 12 weeks during double-blind treatment period (Period III).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '0.49', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '6.1', 'pValueComment': 'Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '6.2', 'pValueComment': 'Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.68', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil (Period III)', 'description': '2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).'}, {'id': 'OG001', 'title': '5 mg Tadalafil (Period III)', 'description': '5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).'}, {'id': 'OG002', 'title': 'Placebo (Period III)', 'description': 'Placebo for 12 weeks during double-blind treatment period (Period III).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '2.1', 'pValueComment': 'Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '2.0', 'pValueComment': 'Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Self-reported intercourse satisfaction over the past 4 weeks. IIEF-IS is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-IS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil (Period III)', 'description': '2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).'}, {'id': 'OG001', 'title': '5 mg Tadalafil (Period III)', 'description': '5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).'}, {'id': 'OG002', 'title': 'Placebo (Period III)', 'description': 'Placebo for 12 weeks during double-blind treatment period (Period III).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '1.7', 'pValueComment': 'Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '1.7', 'pValueComment': 'Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Self-reported overall satisfaction over the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14; each question scored as 1 (low/no satisfaction) through 5 (high satisfaction) with total subscore for the 2 questions of 2 to 10. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-OS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil (Period III)', 'description': '2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).'}, {'id': 'OG001', 'title': '5 mg Tadalafil (Period III)', 'description': '5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).'}, {'id': 'OG002', 'title': 'Placebo (Period III)', 'description': 'Placebo for 12 weeks during double-blind treatment period (Period III).'}], 'classes': [{'title': 'Question 1: Able to Achieve Erection', 'categories': [{'measurements': [{'value': '12.2', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '1.62', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.62', 'groupId': 'OG002'}]}]}, {'title': 'Question 2: Able to Insert', 'categories': [{'measurements': [{'value': '26.2', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '26.1', 'spread': '2.23', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '2.23', 'groupId': 'OG002'}]}]}, {'title': 'Question 3: Successful Intercourse', 'categories': [{'measurements': [{'value': '37.3', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '39.4', 'spread': '2.50', 'groupId': 'OG001'}, {'value': '12.6', 'spread': '2.51', 'groupId': 'OG002'}]}]}, {'title': 'Question 4: Satisfied with Hardness', 'categories': [{'measurements': [{'value': '44.2', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '42.8', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '11.5', 'spread': '2.71', 'groupId': 'OG002'}]}]}, {'title': 'Question 5: Overall Satisfaction with Experience', 'categories': [{'measurements': [{'value': '43.6', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '41.2', 'spread': '2.68', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '2.68', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '10.4', 'pValueComment': 'P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '9.6', 'pValueComment': 'P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.26', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '19.3', 'pValueComment': 'P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '19.3', 'pValueComment': 'P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '24.7', 'pValueComment': 'P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.53', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '26.8', 'pValueComment': 'P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.50', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '32.7', 'pValueComment': 'P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.82', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '31.3', 'pValueComment': 'P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.79', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '33.0', 'pValueComment': 'P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.78', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '30.5', 'pValueComment': 'P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.75', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Questions 1-5. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.', 'unitOfMeasure': 'percentage of "yes" responses', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline SEP Questions assessment, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil (Period III)', 'description': '2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).'}, {'id': 'OG001', 'title': '5 mg Tadalafil (Period III)', 'description': '5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).'}, {'id': 'OG002', 'title': 'Placebo (Period III)', 'description': 'Placebo for 12 weeks during double-blind treatment period (Period III).'}], 'classes': [{'title': 'Confidence to complete sexual activity', 'categories': [{'measurements': [{'value': '27.0', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '29.2', 'spread': '1.78', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '1.77', 'groupId': 'OG002'}]}]}, {'title': 'Ease of erection', 'categories': [{'measurements': [{'value': '24.0', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '24.7', 'spread': '1.69', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '1.68', 'groupId': 'OG002'}]}]}, {'title': 'Pleasure from sexual activity', 'categories': [{'measurements': [{'value': '22.6', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '22.7', 'spread': '1.58', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '1.57', 'groupId': 'OG002'}]}]}, {'title': 'Erectile function satisfaction', 'categories': [{'measurements': [{'value': '31.0', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '33.6', 'spread': '1.81', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '1.81', 'groupId': 'OG002'}]}]}, {'title': 'Satisfaction with orgasm', 'categories': [{'measurements': [{'value': '25.6', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '1.88', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '23.1', 'pValueComment': 'P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.49', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '25.4', 'pValueComment': 'P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.48', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '19.9', 'pValueComment': 'P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '20.6', 'pValueComment': 'P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.35', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '19.3', 'pValueComment': 'P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.21', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '19.5', 'pValueComment': 'P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.20', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '26.0', 'pValueComment': 'P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.54', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '28.7', 'pValueComment': 'P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.53', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '19.3', 'pValueComment': 'P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.65', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '20.1', 'pValueComment': 'P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.64', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The TSS measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TSS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil (Period III)', 'description': '2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).'}, {'id': 'OG001', 'title': '5 mg Tadalafil (Period III)', 'description': '5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).'}, {'id': 'OG002', 'title': 'Placebo (Period III)', 'description': 'Placebo for 12 weeks during double-blind treatment period (Period III).'}], 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '55.9', 'spread': '1.98', 'groupId': 'OG001'}, {'value': '24.8', 'spread': '1.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '28.9', 'pValueComment': 'Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.77', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '31.0', 'pValueComment': 'Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.76', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'The TSS - patient satisfaction with medication measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline participant\'s satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil (Period III)', 'description': '2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).'}, {'id': 'OG001', 'title': '5 mg Tadalafil (Period III)', 'description': '5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).'}, {'id': 'OG002', 'title': 'Placebo (Period III)', 'description': 'Placebo for 12 weeks during double-blind treatment period (Period III).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '0.9', 'pValueComment': 'Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '1.0', 'pValueComment': 'Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Self-reported erectile function over the past 4 weeks. Question 15, confidence in the ability to get an erection, is scored from 1 (very low confidence) to 5 (very high confidence). Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF question 15 (Sexual Confidence) assessment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil (Period III)', 'description': '2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).'}, {'id': 'OG001', 'title': '5 mg Tadalafil (Period III)', 'description': '5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).'}, {'id': 'OG002', 'title': 'Placebo (Period III)', 'description': 'Placebo for 12 weeks during double-blind treatment period (Period III).'}], 'classes': [{'title': 'Confidence to complete sexual activity', 'categories': [{'measurements': [{'value': '23.7', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '27.2', 'spread': '1.99', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.99', 'groupId': 'OG002'}]}]}, {'title': 'Ease of erection', 'categories': [{'measurements': [{'value': '23.1', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.75', 'groupId': 'OG002'}]}]}, {'title': 'Pleasure from sexual activity', 'categories': [{'measurements': [{'value': '18.2', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.68', 'groupId': 'OG002'}]}]}, {'title': 'Erectile function satisfaction', 'categories': [{'measurements': [{'value': '28.6', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '28.5', 'spread': '1.83', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '1.83', 'groupId': 'OG002'}]}]}, {'title': 'Satisfaction with orgasm', 'categories': [{'measurements': [{'value': '18.7', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '2.05', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '2.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '21.7', 'pValueComment': 'P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.81', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '25.2', 'pValueComment': 'P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.78', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '22.3', 'pValueComment': 'P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.46', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '24.5', 'pValueComment': 'P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '16.9', 'pValueComment': 'P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.37', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '17.2', 'pValueComment': 'P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.35', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '25.2', 'pValueComment': 'P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.57', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '25.1', 'pValueComment': 'P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.56', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '15.1', 'pValueComment': 'P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.88', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '17.3', 'pValueComment': 'P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.86', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': "The TSS measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner\'s TSS measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Treatment Satisfaction Scale (TSS) - Partner Satisfaction With Medication Score at Week 12 Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil (Period III)', 'description': '2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).'}, {'id': 'OG001', 'title': '5 mg Tadalafil (Period III)', 'description': '5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).'}, {'id': 'OG002', 'title': 'Placebo (Period III)', 'description': 'Placebo for 12 weeks during double-blind treatment period (Period III).'}], 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '55.7', 'spread': '1.96', 'groupId': 'OG001'}, {'value': '27.5', 'spread': '1.96', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '25.1', 'pValueComment': 'Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.76', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '28.2', 'pValueComment': 'Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.74', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': "The TSS - partner satisfaction with medication measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner\'s satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Having International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 From 12 to 16 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil (Period IV)', 'description': '5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).'}, {'id': 'OG001', 'title': '5 mg Tadalafil (Period IV)', 'description': '5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).'}, {'id': 'OG002', 'title': 'Placebo (Period IV)', 'description': '5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).'}], 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '59.8', 'groupId': 'OG001'}, {'value': '62.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks through 16 weeks', 'description': 'Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of open-label extension treatment period (Period IV).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': "Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil (Period IV)', 'description': '5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).'}, {'id': 'OG001', 'title': '5 mg Tadalafil (Period IV)', 'description': '5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).'}, {'id': 'OG002', 'title': 'Placebo (Period IV)', 'description': '5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).'}], 'classes': [{'title': 'End of Week 12', 'categories': [{'measurements': [{'value': '22.4', 'spread': '6.71', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '7.07', 'groupId': 'OG001'}, {'value': '16.0', 'spread': '7.39', 'groupId': 'OG002'}]}]}, {'title': 'End of Week 16', 'categories': [{'measurements': [{'value': '24.1', 'spread': '6.44', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '6.46', 'groupId': 'OG001'}, {'value': '24.4', 'spread': '6.73', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciPctValue': '95', 'pValueComment': 'Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002'], 'ciPctValue': '95', 'pValueComment': 'Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 16 weeks', 'description': 'Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Change From Week 12 to Week 16 Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil (Period IV)', 'description': '5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).'}, {'id': 'OG001', 'title': '5 mg Tadalafil (Period IV)', 'description': '5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).'}, {'id': 'OG002', 'title': 'Placebo (Period IV)', 'description': '5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).'}], 'classes': [{'title': 'End of Week 12', 'categories': [{'measurements': [{'value': '68.3', 'spread': '38.25', 'groupId': 'OG000'}, {'value': '69.0', 'spread': '37.88', 'groupId': 'OG001'}, {'value': '43.1', 'spread': '39.03', 'groupId': 'OG002'}]}]}, {'title': 'End of Week 16', 'categories': [{'measurements': [{'value': '75.0', 'spread': '34.49', 'groupId': 'OG000'}, {'value': '75.5', 'spread': '34.89', 'groupId': 'OG001'}, {'value': '80.0', 'spread': '34.37', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG001'], 'ciPctValue': '95', 'pValueComment': 'Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002'], 'ciPctValue': '95', 'pValueComment': 'Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 weeks and 16 weeks', 'description': 'Assessed the percentage of Yes responses to the SEP diary Question 3 "Did your erection last long enough for you to have successful intercourse?" from Week 12 (end of double-Blind treatment) to Week 16 (end of open-label treatment).', 'unitOfMeasure': 'percentage of "yes" responses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 SEP diary Question 3 measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil', 'description': '2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.'}, {'id': 'FG001', 'title': '5 mg Tadalafil', 'description': '5.0 mg Tadalafil for 12 weeks during double-blind treatment period.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo for 12 weeks during double-blind treatment period.'}, {'id': 'FG003', 'title': '5 mg Tadalafil Open-Label Extension', 'description': '5 mg Tadalafil for 4 weeks during open-label treatment extension period.'}], 'periods': [{'title': 'Period III (Weeks 0-12)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '207'}, {'groupId': 'FG002', 'numSubjects': '209'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'groupId': 'FG001', 'numSubjects': '205'}, {'groupId': 'FG002', 'numSubjects': '207'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '189'}, {'groupId': 'FG002', 'numSubjects': '190'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period IV (Weeks 13-16)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Three participants who completed Period III chose not to continue into Period IV.', 'groupId': 'FG003', 'numSubjects': '562'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '546'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '552'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'This study consisted of 4 periods. Period I was a 4-week, as needed, run-in period. Period II was a 4-week, non-drug, wash-out period. Period III was a 12-week (Weeks 0-12), double-blind treatment. Period IV was a 4-week (Weeks 13-16), open-label treatment extension. Only participants completing Period III were eligible to continue into Period IV.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '623', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '2.5 mg Titrated to 5 mg Tadalafil', 'description': '2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.'}, {'id': 'BG001', 'title': '5 mg Tadalafil', 'description': '5.0 mg Tadalafil for 12 weeks during double-blind treatment period.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo for 12 weeks during double-blind treatment period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'spread': '10.68', 'groupId': 'BG000'}, {'value': '58.1', 'spread': '10.36', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '10.17', 'groupId': 'BG002'}, {'value': '57.6', 'spread': '10.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '623', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}, {'value': '596', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}, {'value': '517', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}, {'value': '585', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 623}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-03', 'studyFirstSubmitDate': '2010-05-24', 'resultsFirstSubmitDate': '2012-12-03', 'studyFirstSubmitQcDate': '2010-05-24', 'lastUpdatePostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-03', 'studyFirstPostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period)', 'timeFrame': 'Baseline through 12 weeks', 'description': 'Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.'}, {'measure': 'Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Self-reported intercourse satisfaction over the past 4 weeks. IIEF-IS is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.'}, {'measure': 'Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Self-reported overall satisfaction over the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14; each question scored as 1 (low/no satisfaction) through 5 (high satisfaction) with total subscore for the 2 questions of 2 to 10. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.'}, {'measure': 'Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Questions 1-5. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.'}, {'measure': 'Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The TSS measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.'}, {'measure': 'Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint', 'timeFrame': 'Week 12', 'description': 'The TSS - patient satisfaction with medication measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.'}, {'measure': 'Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Self-reported erectile function over the past 4 weeks. Question 15, confidence in the ability to get an erection, is scored from 1 (very low confidence) to 5 (very high confidence). Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.'}, {'measure': 'Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner', 'timeFrame': 'Baseline, 12 weeks', 'description': "The TSS measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction."}, {'measure': 'Treatment Satisfaction Scale (TSS) - Partner Satisfaction With Medication Score at Week 12 Endpoint', 'timeFrame': 'Week 12', 'description': "The TSS - partner satisfaction with medication measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study."}, {'measure': 'Percentage of Participants Having International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 From 12 to 16 Weeks', 'timeFrame': '12 weeks through 16 weeks', 'description': 'Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of open-label extension treatment period (Period IV).'}, {'measure': "Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score", 'timeFrame': '12 weeks and 16 weeks', 'description': 'Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function.'}, {'measure': 'Change From Week 12 to Week 16 Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 3', 'timeFrame': '12 weeks and 16 weeks', 'description': 'Assessed the percentage of Yes responses to the SEP diary Question 3 "Did your erection last long enough for you to have successful intercourse?" from Week 12 (end of double-Blind treatment) to Week 16 (end of open-label treatment).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erectile Dysfunction', 'ED', 'Impotence'], 'conditions': ['Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '25455432', 'type': 'DERIVED', 'citation': 'Kim E, Seftel A, Goldfischer E, Baygani S, Burns P. Comparative efficacy of tadalafil once daily in men with erectile dysfunction who demonstrated previous partial responses to as-needed sildenafil, tadalafil, or vardenafil. Curr Med Res Opin. 2015 Feb;31(2):379-89. doi: 10.1185/03007995.2014.989317. Epub 2014 Dec 2.'}, {'pmid': '23841532', 'type': 'DERIVED', 'citation': 'Kim ED, Seftel AD, Goldfischer ER, Ni X, Burns PR. A return to normal erectile function with tadalafil once daily after an incomplete response to as-needed PDE5 inhibitor therapy. J Sex Med. 2014 Mar;11(3):820-30. doi: 10.1111/jsm.12253. Epub 2013 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to evaluate if treatment with tadalafil once daily will allow men to return to normal erectile function in those who did not have normal erectile function following as-needed (PRN) Phosphodiesterase Type 5 (PDE5) Inhibitor treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least a 3-month history of erectile dysfunction (ED).\n* Are able to read, understand and provide signed informed consent.\n* Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is greater than or equal to 17 and less than 26 at screening.\n* Have been taking a maximum dose of sildenafil citrate (100 milligram \\[mg\\]), vardenafil (20 mg), or tadalafil (20 mg) on as needed basis for at least one month prior to screening.\n* Anticipate having the same female sexual partner during the study who is willing to participate in the required number of sexual intercourse attempts and complete study measures during the study.\n* Agree to make at least four sexual intercourse attempts during both the 4-week as needed run-in period and the 4-week non-drug run-in period.\n* Agree not to use any other erectile dysfunction (ED) treatment, including herbal therapy during the 4-week non-drug, run-in, the double-blind treatment period, the open label period and for 96 hours after the end of the study.\n\nPartner Inclusion Criteria:\n\n* Are female and at least 18 years of age at screening.\n* Anticipate having the same male study subject as her sexual partner during the study.\n* Able to read, understand and provide signed informed consent.\n* Agree to make the required number of sexual intercourse attempts with the male sexual study partner during the study.\n* Willing to participate in recording responses to the treatment satisfaction scale.\n\nExclusion Criteria:\n\n* Have an IIEF-EF domain score of greater than or equal to 26 at screening.\n* Prior ineffective treatment with (or nonresponder to) any PDE5 Inhibitor\n* Have previously used or are currently using any PDE5 inhibitor once daily.\n* Present with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease.\n* Partner unwilling to complete all study requirements.\n* History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator\n* Exhibit evidence of clinically significant renal insufficiency or hepatobiliary disease, or significant cardiac history as determined by the investigator\n* Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens\n* Have previously completed or withdrawn from this study or any other study investigating tadalafil for once-daily use.'}, 'identificationModule': {'nctId': 'NCT01130532', 'briefTitle': 'A Study in Erectile Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Tadalafil Once Daily Following As-Needed Phosphodiesterase Type 5 Inhibitor Treatment, an Assessment of Return to Normal Erectile Function', 'orgStudyIdInfo': {'id': '13461'}, 'secondaryIdInfos': [{'id': 'H6D-US-LVIP', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2.5 milligram (mg) titrated to 5 mg Tadalafil', 'description': '2.5 mg for 4 weeks, followed by 5 mg for 8 weeks with option to continue treatment at 5 mg for an additional 4 weeks', 'interventionNames': ['Drug: Tadalafil']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5 mg Tadalafil', 'description': '5.0 mg for 12 weeks with option to continue treatment for additional 4 weeks', 'interventionNames': ['Drug: Tadalafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tadalafil', 'type': 'DRUG', 'otherNames': ['Cialis', 'LY450190'], 'description': 'Administer orally', 'armGroupLabels': ['2.5 milligram (mg) titrated to 5 mg Tadalafil', '5 mg Tadalafil']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administer orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '06052', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32765', 'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'zip': '83646', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '83686', 'city': 'Nampa', 'state': 'Idaho', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.54072, 'lon': -116.56346}}, {'zip': '66043', 'city': 'Lansing', 'state': 'Kansas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.24861, 'lon': -94.90024}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '01830', 'city': 'Haverhill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.7762, 'lon': -71.07728}}, {'zip': '48085', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '08753', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '11530', 'city': 'Garden City', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '28025', 'city': 'Concord', 'state': 'North Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.40888, 'lon': -80.58158}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '44124', 'city': 'Lyndhurst', 'state': 'Ohio', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.52005, 'lon': -81.48873}}, {'zip': '19004', 'city': 'Bala-Cynwyd', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.00761, 'lon': -75.23407}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84015', 'city': 'Clinton', 'state': 'Utah', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.13967, 'lon': -112.0505}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98166', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99220', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': 'V3A 4H9', 'city': 'Langley', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.10107, 'lon': -122.65883}}, {'zip': 'V8T 5G1', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'L7N 3V2', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'M3B 3S6', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': 'H2X 1N8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'S7K 7H9', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}