Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT00853606
Status:
COMPLETED
Last Update Posted:
2012-08-17
First Post:
2009-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
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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 received at least one dose of avanafil during TA-314 and who have any safety data.', 'eventGroups': [{'id': 'EG000', 'title': 'Avanafil', 'description': 'All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.', 'otherNumAtRisk': 712, 'otherNumAffected': 87, 'seriousNumAtRisk': 712, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'Acute physchosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'syncope vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'subdural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 712, 'numAffected': 1}], 'organSystem': 'Cardiac 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': '686', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avanafil', 'description': 'All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.75', 'spread': '35.915', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 52 weeks', 'description': 'Data presented as mean change from baseline and the treatment period 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?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.', 'unitOfMeasure': 'percentage of sexual attempts', 'dispersionType': 'Standard Deviation', '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': '686', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avanafil', 'description': 'All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.91', 'spread': '36.142', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 52 weeks', 'description': 'Data presented as mean change from baseline and the treatment period 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?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.', 'unitOfMeasure': 'percentage of sexual attempts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed represents to 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': '686', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avanafil', 'description': 'All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '7.88', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of Treatment', '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. Baseline is the observation at Visit 2 of the qualifying study (TA-301/TA-302). End of treatment is the observation at Visit 8 of the last observation carried forward.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed represents the Intent-to-Treat population. For dropouts of missing data, the last observation carried forward convention was used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Avanafil', 'description': 'All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '712'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '492'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}]}]}], 'recruitmentDetails': 'Subject recruitment occurred at US investigative sites between March 2009 and April 2010.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Avanafil', 'description': 'All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'spread': '10.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '712', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '712', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 712}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'dispFirstSubmitDate': '2011-06-06', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-10', 'studyFirstSubmitDate': '2009-02-27', 'dispFirstSubmitQcDate': '2011-06-06', 'resultsFirstSubmitDate': '2012-05-25', 'studyFirstSubmitQcDate': '2009-02-27', 'dispFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-25', 'studyFirstPostDateStruct': {'date': '2009-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', '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, 52 weeks', 'description': 'Data presented as mean change from baseline and the treatment period 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?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.'}, {'measure': "Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina", 'timeFrame': 'Baseline, 52 weeks', 'description': 'Data presented as mean change from baseline and the treatment period 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?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.'}, {'measure': 'Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score', 'timeFrame': 'Baseline, End of Treatment', '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. Baseline is the observation at Visit 2 of the qualifying study (TA-301/TA-302). End of treatment is the observation at Visit 8 of the last observation carried forward."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ED', 'Erectile Dysfunction', 'Dysfunction', 'Erectile'], 'conditions': ['Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '23521325', 'type': 'DERIVED', 'citation': 'Belkoff LH, McCullough A, Goldstein I, Jones L, Bowden CH, DiDonato K, Trask B, Day WW. An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction. Int J Clin Pract. 2013 Apr;67(4):333-41. doi: 10.1111/ijcp.12065.'}]}, 'descriptionModule': {'briefSummary': 'This open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400 subjects will be enrolled and treated with avanafil for up to 52 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Successfully completed the entire treatment period in a qualifying study (TA-301 \\[NCT00790751\\] or TA-302 \\[NCT00809471\\]);\n* Demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;\n* Made at least 4 attempts at intercourse during the last treatment period of the qualifying trial;\n* Agree to make at least 4 attempts at intercourse each month through the course of this study;\n* Agree not to use any other treatments for erectile dysfunction during participation in this study.\n* Provide written informed consent;\n* Willing and able to comply with scheduled study visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study TA-314;\n* Subjects requiring treatment with an excluded medication.'}, 'identificationModule': {'nctId': 'NCT00853606', 'briefTitle': 'Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'VIVUS LLC'}, 'officialTitle': 'An Open-Label, Long-Term Evaluation of the Safety and Efficacy of Avanafil in Men With Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'TA-314'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'avanafil', 'interventionNames': ['Drug: avanafil']}], 'interventions': [{'name': 'avanafil', 'type': 'DRUG', 'otherNames': ['TA-1790', 'Stendra'], 'description': 'All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with 100 mg may undergo dose reduction to 50 mg. Subjects who tolerate avanafil 100 mg but who desire increased efficacy may request a dose increase to 200 mg.', 'armGroupLabels': ['avanafil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35209', 'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 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'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19004', 'city': 'Bala-Cynwyd', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.00761, 'lon': -75.23407}}, {'zip': '17601', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '79935', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77386', 'city': 'Spring', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.07994, 'lon': -95.41716}}], 'overallOfficials': [{'name': 'Andrew McCullough, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Urology Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VIVUS LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}