Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-05 @ 12:56 AM
Study NCT ID:
NCT00909233
Status:
COMPLETED
Last Update Posted:
2014-12-15
First Post:
2009-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LEVITRA® 20mg Special Drug Use Investigation (Long-term)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000069058', 'term': 'Vardenafil Dihydrochloride'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-12', 'studyFirstSubmitDate': '2009-05-08', 'studyFirstSubmitQcDate': '2009-05-26', 'lastUpdatePostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of patients with LEVITRA treatment', 'timeFrame': 'After 6 months'}], 'secondaryOutcomes': [{'measure': "LEVITRA treatment improved the patient's erection", 'timeFrame': 'After 6 months'}, {'measure': "LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse", 'timeFrame': 'After 6 months'}, {'measure': 'Reporting a second successful intercourse within 24 hours of dosing', 'timeFrame': 'After 6 months'}, {'measure': 'Patients prefer LEVITRA over last Erectile Dysfunction treatment', 'timeFrame': 'After 6 months'}, {'measure': 'Tolerability of patients with LEVITRA treatment', 'timeFrame': 'After 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erectile dysfunction,', 'Phosphodiesterase Inhibitors'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.'}, 'identificationModule': {'nctId': 'NCT00909233', 'briefTitle': 'LEVITRA® 20mg Special Drug Use Investigation (Long-term)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'LEVITRA® 20mg Special Drug Use Investigation (Long-term)', 'orgStudyIdInfo': {'id': '13930'}, 'secondaryIdInfos': [{'id': 'LV0701JP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Vardenafil, (Levitra, BAY38-9456)']}], 'interventions': [{'name': 'Vardenafil, (Levitra, BAY38-9456)', 'type': 'DRUG', 'description': 'Patients under daily life treatment receiving Levitra according to local drug information.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Director', 'oldOrganization': 'Bayer Yakuhin Ltd'}}}}