Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT01037218
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2009-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Erectile Dysfunction II
Sponsor:
Organization:
Raw JSON
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{'timeFrame': 'Twelve weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets', 'otherNumAtRisk': 147, 'otherNumAffected': 43, 'seriousNumAtRisk': 147, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets', 'otherNumAtRisk': 148, 'otherNumAffected': 51, 'seriousNumAtRisk': 148, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets', 'otherNumAtRisk': 150, 'otherNumAffected': 49, 'seriousNumAtRisk': 154, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo tablets', 'otherNumAtRisk': 150, 'otherNumAffected': 11, 'seriousNumAtRisk': 150, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sinus Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blood Creatine Phosphokinase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'seriousEvents': [{'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Lung Squamous Cell Carcinoma Stage Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'OG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'OG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '3.79', 'groupId': 'OG000', 'lowerLimit': '2.58', 'upperLimit': '5.00'}, {'value': '6.14', 'groupId': 'OG001', 'lowerLimit': '4.92', 'upperLimit': '7.37'}, {'value': '7.94', 'groupId': 'OG002', 'lowerLimit': '6.75', 'upperLimit': '9.12'}, {'value': '0.41', 'groupId': 'OG003', 'lowerLimit': '-0.81', 'upperLimit': '1.62'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.38', 'ciLowerLimit': '1.70', 'ciUpperLimit': '5.07', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.74', 'ciLowerLimit': '4.05', 'ciUpperLimit': '7.43', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.53', 'ciLowerLimit': '5.86', 'ciUpperLimit': '9.20', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get \\& keep your erection?', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT, LOCF'}, {'type': 'PRIMARY', 'title': 'Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'OG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'OG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '14.47', 'groupId': 'OG000', 'lowerLimit': '9.60', 'upperLimit': '19.33'}, {'value': '19.34', 'groupId': 'OG001', 'lowerLimit': '14.46', 'upperLimit': '24.23'}, {'value': '27.12', 'groupId': 'OG002', 'lowerLimit': '22.39', 'upperLimit': '31.85'}, {'value': '-5.72', 'groupId': 'OG003', 'lowerLimit': '-10.57', 'upperLimit': '-0.86'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.19', 'ciLowerLimit': '13.44', 'ciUpperLimit': '26.93', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values were obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.06', 'ciLowerLimit': '18.32', 'ciUpperLimit': '31.81', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values were obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.84', 'ciLowerLimit': '26.18', 'ciUpperLimit': '39.50', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values were obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1-12', 'description': "Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.", 'unitOfMeasure': 'Percentage of Yes Reponses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'PRIMARY', 'title': 'Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'OG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'OG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '33.24', 'groupId': 'OG000', 'lowerLimit': '27.81', 'upperLimit': '38.67'}, {'value': '38.34', 'groupId': 'OG001', 'lowerLimit': '32.89', 'upperLimit': '43.80'}, {'value': '46.93', 'groupId': 'OG002', 'lowerLimit': '41.66', 'upperLimit': '52.20'}, {'value': '11.53', 'groupId': 'OG003', 'lowerLimit': '6.10', 'upperLimit': '16.95'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.72', 'ciLowerLimit': '14.19', 'ciUpperLimit': '29.24', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values were obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.82', 'ciLowerLimit': '19.27', 'ciUpperLimit': '34.37', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values were obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.41', 'ciLowerLimit': '27.98', 'ciUpperLimit': '42.83', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values were obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1-12', 'description': 'Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.', 'unitOfMeasure': 'Percentage of Yes Responses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'OG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'OG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '1.49', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '2.00'}, {'value': '2.25', 'groupId': 'OG001', 'lowerLimit': '1.73', 'upperLimit': '2.76'}, {'value': '2.86', 'groupId': 'OG002', 'lowerLimit': '2.36', 'upperLimit': '3.36'}, {'value': '-0.04', 'groupId': 'OG003', 'lowerLimit': '-0.55', 'upperLimit': '0.47'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '0.81', 'ciUpperLimit': '2.23', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.29', 'ciLowerLimit': '1.58', 'ciUpperLimit': '3.00', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.90', 'ciLowerLimit': '2.20', 'ciUpperLimit': '3.60', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT, LOCF'}, {'type': 'SECONDARY', 'title': 'Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'OG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'OG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '1.29'}, {'value': '1.77', 'groupId': 'OG001', 'lowerLimit': '1.32', 'upperLimit': '2.23'}, {'value': '1.78', 'groupId': 'OG002', 'lowerLimit': '1.33', 'upperLimit': '2.22'}, {'value': '0.25', 'groupId': 'OG003', 'lowerLimit': '-0.21', 'upperLimit': '0.70'}]}]}], 'analyses': [{'pValue': '0.0673', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '1.22', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '0.90', 'ciUpperLimit': '2.16', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '0.91', 'ciUpperLimit': '2.15', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Orgasmic Function domain: 0/poor - 5/good scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)?', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT, LOCF'}, {'type': 'SECONDARY', 'title': 'Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'OG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'OG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.57'}, {'value': '0.65', 'groupId': 'OG001', 'lowerLimit': '0.38', 'upperLimit': '0.92'}, {'value': '0.65', 'groupId': 'OG002', 'lowerLimit': '0.39', 'upperLimit': '0.91'}, {'value': '-0.06', 'groupId': 'OG003', 'lowerLimit': '-0.32', 'upperLimit': '0.21'}]}]}], 'analyses': [{'pValue': '0.0566', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.73', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.08', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.07', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Sexual Desire domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire?', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT, LOCF'}, {'type': 'SECONDARY', 'title': 'Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'OG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'OG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '1.07', 'upperLimit': '1.85'}, {'value': '2.15', 'groupId': 'OG001', 'lowerLimit': '1.76', 'upperLimit': '2.55'}, {'value': '2.69', 'groupId': 'OG002', 'lowerLimit': '2.31', 'upperLimit': '3.07'}, {'value': '0.60', 'groupId': 'OG003', 'lowerLimit': '0.21', 'upperLimit': '0.99'}]}]}], 'analyses': [{'pValue': '0.0019', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.32', 'ciUpperLimit': '1.40', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.55', 'ciLowerLimit': '1.01', 'ciUpperLimit': '2.09', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.09', 'ciLowerLimit': '1.55', 'ciUpperLimit': '2.62', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Overall Satisfaction domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner?', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT, LOCF'}, {'type': 'SECONDARY', 'title': 'Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'OG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'OG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'Cochran-Armitage test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders)', 'unitOfMeasure': 'Yes Responders', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'OG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'OG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '57.20', 'groupId': 'OG000', 'lowerLimit': '53.13', 'upperLimit': '61.27'}, {'value': '64.16', 'groupId': 'OG001', 'lowerLimit': '60.05', 'upperLimit': '68.27'}, {'value': '71.56', 'groupId': 'OG002', 'lowerLimit': '67.59', 'upperLimit': '75.53'}, {'value': '44.55', 'groupId': 'OG003', 'lowerLimit': '40.49', 'upperLimit': '48.61'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.65', 'ciLowerLimit': '7.01', 'ciUpperLimit': '18.29', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANOVA model with pooled site as a covariate.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.61', 'ciLowerLimit': '13.95', 'ciUpperLimit': '25.27', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANOVA model with pooled site as a covariate.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.01', 'ciLowerLimit': '21.44', 'ciUpperLimit': '32.59', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANOVA model with pooled site as a covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use ? How satisfied w/how quickly it works? How long it lasts? How confident has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT, LOCF'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'OG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'OG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.39', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '0.49'}, {'value': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '0.60'}, {'value': '0.78', 'groupId': 'OG002', 'lowerLimit': '0.69', 'upperLimit': '0.88'}, {'value': '-0.05', 'groupId': 'OG003', 'lowerLimit': '-0.15', 'upperLimit': '0.05'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.57', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.40', 'ciUpperLimit': '0.68', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.97', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'OG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'OG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '3.39', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '6.97'}, {'value': '3.16', 'groupId': 'OG001', 'lowerLimit': '-0.44', 'upperLimit': '6.75'}, {'value': '9.28', 'groupId': 'OG002', 'lowerLimit': '5.80', 'upperLimit': '12.76'}, {'value': '-11.78', 'groupId': 'OG003', 'lowerLimit': '-15.36', 'upperLimit': '-8.20'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.18', 'ciLowerLimit': '10.21', 'ciUpperLimit': '20.14', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.94', 'ciLowerLimit': '9.96', 'ciUpperLimit': '19.92', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.06', 'ciLowerLimit': '16.15', 'ciUpperLimit': '25.96', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1-12', 'description': 'SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.', 'unitOfMeasure': 'Percentage Yes Responses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'OG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'OG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '27.12', 'groupId': 'OG000', 'lowerLimit': '21.85', 'upperLimit': '32.38'}, {'value': '37.92', 'groupId': 'OG001', 'lowerLimit': '32.63', 'upperLimit': '43.21'}, {'value': '43.42', 'groupId': 'OG002', 'lowerLimit': '38.31', 'upperLimit': '48.54'}, {'value': '9.61', 'groupId': 'OG003', 'lowerLimit': '4.35', 'upperLimit': '14.86'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.51', 'ciLowerLimit': '10.22', 'ciUpperLimit': '24.81', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.32', 'ciLowerLimit': '21.01', 'ciUpperLimit': '35.62', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.82', 'ciLowerLimit': '26.61', 'ciUpperLimit': '41.02', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1-12', 'description': 'SEP Question 4: Were you satisfied with the hardness of your erection? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.', 'unitOfMeasure': 'Percentage Yes Responses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'OG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'OG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '26.27', 'groupId': 'OG000', 'lowerLimit': '20.86', 'upperLimit': '31.68'}, {'value': '36.93', 'groupId': 'OG001', 'lowerLimit': '31.48', 'upperLimit': '42.38'}, {'value': '41.88', 'groupId': 'OG002', 'lowerLimit': '36.62', 'upperLimit': '47.14'}, {'value': '7.53', 'groupId': 'OG003', 'lowerLimit': '2.13', 'upperLimit': '12.94'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.73', 'ciLowerLimit': '11.23', 'ciUpperLimit': '26.23', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.39', 'ciLowerLimit': '21.86', 'ciUpperLimit': '36.92', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.35', 'ciLowerLimit': '26.94', 'ciUpperLimit': '41.75', 'groupDescription': '540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001(NCT00282607).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1-12', 'description': 'SEP Question 5: Were you satisfied with this overall sexual experience? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.', 'unitOfMeasure': 'Percentage Yes Responses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'FG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'FG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo tablets'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '149'}, {'groupId': 'FG002', 'numSubjects': '155'}, {'groupId': 'FG003', 'numSubjects': '150'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '148'}, {'groupId': 'FG002', 'numSubjects': '154'}, {'groupId': 'FG003', 'numSubjects': '150'}]}, {'type': 'mITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '140'}, {'groupId': 'FG002', 'numSubjects': '147'}, {'groupId': 'FG003', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '134'}, {'groupId': 'FG003', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Partner Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Various', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'First Subject enrolled 28-Sep-2009'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}, {'value': '601', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Udenafil 50 mg', 'description': 'Udenafil 50 mg tablets'}, {'id': 'BG001', 'title': 'Udenafil 100 mg', 'description': 'Udenafil 100 mg tablets'}, {'id': 'BG002', 'title': 'Udenafil 150mg', 'description': 'Udenafil 150mg tablets'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo tablets'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'spread': '8.92', 'groupId': 'BG000'}, {'value': '56.8', 'spread': '10.22', 'groupId': 'BG001'}, {'value': '58.7', 'spread': '9.48', 'groupId': 'BG002'}, {'value': '58.9', 'spread': '10.31', 'groupId': 'BG003'}, {'value': '58.4', 'spread': '9.77', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Safety Population', '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'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}, {'value': '601', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}, {'value': '570', 'groupId': 'BG004'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Race Safety Population', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}, {'value': '520', 'groupId': 'BG004'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Safety Population', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}, {'value': '601', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects Randomized/Enrolled; Age, Ethnic, Race only available for Safety Population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 601}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2009-10-19', 'resultsFirstSubmitDate': '2011-07-12', 'studyFirstSubmitQcDate': '2009-12-18', 'lastUpdatePostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-12-21', 'studyFirstPostDateStruct': {'date': '2009-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)', 'timeFrame': 'Baseline and Week 12', 'description': 'Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get \\& keep your erection?'}, {'measure': 'Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT', 'timeFrame': 'Baseline and Weeks 1-12', 'description': "Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period."}, {'measure': 'Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT', 'timeFrame': 'Baseline and Weeks 1-12', 'description': 'Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.'}], 'secondaryOutcomes': [{'measure': 'Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF', 'timeFrame': 'Baseline and Week 12', 'description': 'Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?'}, {'measure': 'Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF', 'timeFrame': 'Baseline and Week 12', 'description': 'Orgasmic Function domain: 0/poor - 5/good scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)?'}, {'measure': 'Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF', 'timeFrame': 'Baseline and Week 12', 'description': 'Sexual Desire domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire?'}, {'measure': 'Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF', 'timeFrame': 'Baseline and Week 12', 'description': 'Overall Satisfaction domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner?'}, {'measure': 'Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population', 'timeFrame': 'Week 12', 'description': 'While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders)'}, {'measure': 'Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT', 'timeFrame': 'Baseline and Week 12', 'description': 'EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use ? How satisfied w/how quickly it works? How long it lasts? How confident has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?'}, {'measure': 'Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population', 'timeFrame': 'Baseline and Week 12', 'description': 'PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity'}, {'measure': 'Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT', 'timeFrame': 'Baseline and Weeks 1-12', 'description': 'SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.'}, {'measure': 'Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT', 'timeFrame': 'Baseline and Weeks 1-12', 'description': 'SEP Question 4: Were you satisfied with the hardness of your erection? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.'}, {'measure': 'Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT', 'timeFrame': 'Baseline and Weeks 1-12', 'description': 'SEP Question 5: Were you satisfied with this overall sexual experience? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).', 'detailedDescription': 'Multi-center, randomized, double-blind, placebo-controlled, parallel-group design, Phase 3 pivotal study to investigate the efficacay and safety of 50 mg, 100 mg and 150 mg udenafil tablets compared with placebo in men with ED. This study consisted of a 4-week, treatment free run-in period followed by a treatment period of 12 weeks, with an on-demand dosing regimen.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, at least 19 years of age\n* Stable monogamous relationship for at least 6 months with a consenting female partner who is at least 19 years of age, vaginal intercourse is a required study activity\n* History of ED (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration\n* Partner is not pregnant or lactating\n\nExclusion Criteria:\n\n* History of new-onset symptomatic coronary artery disease within the last 3 months or a history of myocardial infarction or cardiac surgical procedure within six months\n* Cardiac arrhythmias requiring antiarrhythmic treatment\n* Symptomatic congestive heart failure\n* Taking nitrate medication in any form\n* Uncontrolled diabetes (HbA1c ≥ 13%)\n* Hypersensitivity to phosphodiesterase type 5 (PDE-5) inhibitors such as Viagra®, Cialis® or Levitra®\n* Previously failed to respond to PDE-5 inhibitors such as Viagra®, Cialis® or Levitra®'}, 'identificationModule': {'nctId': 'NCT01037218', 'briefTitle': 'Treatment of Erectile Dysfunction II', 'organization': {'class': 'INDUSTRY', 'fullName': 'Warner Chilcott'}, 'officialTitle': 'Randomized, Placebo-controlled, Double-Blind, Parallel Design, Phase 3 Study to Assess the Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'PR-01309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Udenafil 50 mg', 'description': '50 mg Udenafil tablet plus 100 \\& 150 mg placebo tablets', 'interventionNames': ['Drug: Udenafil', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Udenafil 100 mg', 'description': '100 mg Udenafil tablet plus 50 \\& 150 mg placebo tablets', 'interventionNames': ['Drug: Udenafil', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Udenafil 150mg', 'description': '150 mg Udenafil tablet plus 50 \\& 100 mg placebo tablets', 'interventionNames': ['Drug: Udenafil', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '50, 100 \\& 150 mg placebo tablets', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Udenafil', 'type': 'DRUG', 'description': 'Tablets via oral administration before an attempt at sexual intercourse.', 'armGroupLabels': ['Udenafil 100 mg', 'Udenafil 150mg', 'Udenafil 50 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets via oral administration before an attempt at sexual intercourse.', 'armGroupLabels': ['Placebo', 'Udenafil 100 mg', 'Udenafil 150mg', 'Udenafil 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 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