Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT00790751
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
2008-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C553414', 'term': 'avanafil'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '650-934-5200', 'title': 'Wesley W Day PhD', 'organization': 'Vivus, Inc'}, 'certainAgreement': {'otherDetails': "After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution \\& PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.', 'description': '\\# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'placebo 30 minutes orally prior to initiation of sexual activity', 'otherNumAtRisk': 161, 'otherNumAffected': 7, 'seriousNumAtRisk': 161, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Avanafil 50 mg', 'description': 'avanafil 50 mg 30 minutes orally prior to initiation of sexual activity', 'otherNumAtRisk': 160, 'otherNumAffected': 16, 'seriousNumAtRisk': 160, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Avanafil 100 mg', 'description': 'avanafil 100 mg 30 minutes orally prior to initiation of sexual activity', 'otherNumAtRisk': 161, 'otherNumAffected': 28, 'seriousNumAtRisk': 161, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Avanafil 200 mg', 'description': 'avanafil 200 mg 30 minutes orally prior to initiation of sexual activity', 'otherNumAtRisk': 162, 'otherNumAffected': 31, 'seriousNumAtRisk': 162, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 162, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 162, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 162, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 162, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Prostate cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Infected bites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 30 minutes orally prior to initiation of sexual activity'}, {'id': 'OG001', 'title': 'Avanafil 50 mg', 'description': 'avanafil 50 mg 30 minutes orally prior to initiation of sexual activity'}, {'id': 'OG002', 'title': 'Avanafil 100 mg', 'description': 'avanafil 100 mg 30 minutes orally prior to initiation of sexual activity'}, {'id': 'OG003', 'title': 'Avanafil 200 mg', 'description': 'avanafil 200 mg 30 minutes orally prior to initiation of sexual activity'}], 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '43.4', 'spread': '2.56', 'groupId': 'OG002'}, {'value': '44.2', 'spread': '2.57', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?"', 'unitOfMeasure': 'percentage of sexual attempts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed represents the Intent-to-Treat population.'}, {'type': 'PRIMARY', 'title': "Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina", 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 30 minutes orally prior to initiation of sexual activity'}, {'id': 'OG001', 'title': 'Avanafil 50 mg', 'description': 'avanafil 50 mg 30 minutes orally prior to initiation of sexual activity'}, {'id': 'OG002', 'title': 'Avanafil 100 mg', 'description': 'avanafil 100 mg 30 minutes orally prior to initiation of sexual activity'}, {'id': 'OG003', 'title': 'Avanafil 200 mg', 'description': 'avanafil 200 mg 30 minutes orally prior to initiation of sexual activity'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '2.34', 'groupId': 'OG001'}, {'value': '27.2', 'spread': '2.32', 'groupId': 'OG002'}, {'value': '29.8', 'spread': '2.33', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 "Were you able to insert your penis into your partner\'s vagina?"', 'unitOfMeasure': 'percentage of sexual attempts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed represents the Intent-to-Treat population.'}, {'type': 'PRIMARY', 'title': 'Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '155', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 30 minutes orally prior to initiation of sexual activity'}, {'id': 'OG001', 'title': 'Avanafil 50 mg', 'description': 'avanafil 50 mg 30 minutes orally prior to initiation of sexual activity'}, {'id': 'OG002', 'title': 'Avanafil 100 mg', 'description': 'avanafil 100 mg 30 minutes orally prior to initiation of sexual activity'}, {'id': 'OG003', 'title': 'Avanafil 200 mg', 'description': 'avanafil 200 mg 30 minutes orally prior to initiation of sexual activity'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '9.5', 'spread': '0.56', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, End of Treatment (up to 12 weeks)', 'description': "Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 \\& 15 ranges from 1 to 30. A higher score indicates better erectile function.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'placebo 30 minutes orally prior to initiation of sexual activity'}, {'id': 'FG001', 'title': 'Avanafil 50 mg', 'description': 'avanafil 50 mg 30 minutes orally prior to initiation of sexual activity'}, {'id': 'FG002', 'title': 'Avanafil 100 mg', 'description': 'avanafil 100 mg 30 minutes orally prior to initiation of sexual activity'}, {'id': 'FG003', 'title': 'Avanafil 200 mg', 'description': 'avanafil 200 mg 30 minutes orally prior to initiation of sexual activity'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '161'}, {'groupId': 'FG002', 'numSubjects': '161'}, {'groupId': 'FG003', 'numSubjects': '162'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '131'}, {'groupId': 'FG002', 'numSubjects': '141'}, {'groupId': 'FG003', 'numSubjects': '141'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Protocol non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Requirement for restricted medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subject recruitment occurred at US investigative sites between November 2008 and April 2009.', 'preAssignmentDetails': 'Subjects meeting the initial eligibility criteria completed a 4-week non-treatment run-in period during which information on each attempt at intercourse was recorded. At the end of the run-in, subjects meeting the randomization criteria were eligible for assignment to one of the treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}, {'value': '646', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'placebo 30 minutes orally prior to initiation of sexual activity'}, {'id': 'BG001', 'title': 'Avanafil 50 mg', 'description': 'avanafil 50 mg 30 minutes orally prior to initiation of sexual activity'}, {'id': 'BG002', 'title': 'Avanafil 100 mg', 'description': 'avanafil 100 mg 30 minutes orally prior to initiation of sexual activity'}, {'id': 'BG003', 'title': 'Avanafil 200 mg', 'description': 'avanafil 200 mg 30 minutes orally prior to initiation of sexual activity'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'spread': '11.13', 'groupId': 'BG000'}, {'value': '55.4', 'spread': '10.81', 'groupId': 'BG001'}, {'value': '56.5', 'spread': '10.32', 'groupId': 'BG002'}, {'value': '55.7', 'spread': '11.33', 'groupId': 'BG003'}, {'value': '55.7', 'spread': '10.89', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}, {'value': '646', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}, {'value': '646', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 646}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'dispFirstSubmitDate': '2011-06-06', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-27', 'studyFirstSubmitDate': '2008-11-10', 'dispFirstSubmitQcDate': '2011-06-06', 'resultsFirstSubmitDate': '2012-05-25', 'studyFirstSubmitQcDate': '2008-11-10', 'dispFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-25', 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?"'}, {'measure': "Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina", 'timeFrame': 'Baseline, 12 weeks', 'description': 'Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 "Were you able to insert your penis into your partner\'s vagina?"'}, {'measure': 'Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score', 'timeFrame': 'Baseline, End of Treatment (up to 12 weeks)', 'description': "Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 \\& 15 ranges from 1 to 30. A higher score indicates better erectile function."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ED', 'Erectile Dysfunction', 'Dysfunction', 'Erectile'], 'conditions': ['Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '22248153', 'type': 'RESULT', 'citation': 'Goldstein I, McCullough AR, Jones LA, Hellstrom WJ, Bowden CH, Didonato K, Trask B, Day WW. A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction. J Sex Med. 2012 Apr;9(4):1122-33. doi: 10.1111/j.1743-6109.2011.02629.x. Epub 2012 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to placebo in men with mild to severe erectile dysfunction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects, age ≥ 18 years;\n* Minimum 6 month history of mild to severe erectile dysfunction;\n* Subject is in a monogamous, heterosexual relationship for at least 3 months;\n* Subject agrees to make at least 4 attempts at intercourse per month;\n* Subject is willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Allergy or hypersensitivity to PDE5 inhibitors;\n* History of dose-limiting AEs during therapy with a PDE5 inhibitor or hx of consistent treatment failure with other PDE5 inhibitors for therapy of ED;\n* Current or expected use of organic nitrates at any time during the study;\n* Previous or current antiandrogen therapy;\n* Use of prescription or over-the-counter drugs known to inhibit the activity of CYP3A4 at any time during the study;\n* Androgen replacement therapy that has not been stable for at least 3 month;\n* Initiation or change in dose of any alpha-blocker within 14 days prior to randomization;\n* ED as a result of spinal cord injury or radical prostatectomy;\n* Untreated hypogonadism or low serum total testosterone\n* History of or predisposition to priapism;\n* Any penile implant;\n* Elevated PSA, other evidence of prostate cancer, or previous radical prostatectomy;\n* History of any malignancy (except basal cell carcinoma or squamous cell carcinoma of the skin successfully treated by curative excision);\n* History of type 1 or type 2 diabetes;\n* Uncontrolled hypertension;\n* Hypotension;\n* Orthostatic hypotension;\n* Significant cardiovascular disease;\n* Abnormal ECG;\n* Hepatic or renal impairment;\n* Positive STD screen;\n* Clinically evident penile lesions, abrasions, or anatomical deformities;\n* Urinary tract or bladder infection;\n* Use of any treatment for erectile dysfunction other than study drug at any time during the study;\n* Participation in another investigational study within 30 days of screening or at any time during this study;\n* Previous participation in any other investigational study of avanafil;\n* History or current drug, alcohol, or substance abuse;\n* Any history of bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity or antidepressant use that has not been stable for at least 3 months;\n* Partners who are \\< 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems or major medical conditions that would limit participation in sexual intercourse;\n* Evidence of any other condition by history, physical examination, or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity, or confound the interpretation of study results.'}, 'identificationModule': {'nctId': 'NCT00790751', 'acronym': 'REVIVE', 'briefTitle': 'Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED', 'organization': {'class': 'INDUSTRY', 'fullName': 'VIVUS LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil (TA-1790) in Subjects With Generalized Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'TA-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'avanafil 50 mg', 'interventionNames': ['Drug: avanafil']}, {'type': 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