Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-01-26 @ 6:34 PM
Study NCT ID:
NCT00668018
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2008-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 887}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-18', 'studyFirstSubmitDate': '2008-04-24', 'studyFirstSubmitQcDate': '2008-04-27', 'lastUpdatePostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'International Index of Erectile Function', 'timeFrame': '12 weeks'}, {'measure': 'Global Assessment Question (GAQ)', 'timeFrame': '12 weeks'}, {'measure': 'Other diary responses', 'timeFrame': '12 weeks'}, {'measure': 'General Safety', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Male Erectile Dysfunction', 'Vardenafil'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'Assess efficacy of vardenafil within 6 hours after intake'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 years and older\n* Males with erectile dysfunction\n* Stable heterosexual relationship\n\nExclusion Criteria:\n\n* Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months\n* Nitrate use'}, 'identificationModule': {'nctId': 'NCT00668018', 'briefTitle': 'Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Open-label, Multicenter Study to Assess Safety, Tolerability, Efficacy and Impact on Quality of Life of Vardenafil 10mg in Patients With Erectile Dysfunction Within a Time Window of up to 6 Hours After Intake of Study Drug', 'orgStudyIdInfo': {'id': '10678'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Levitra (Vardenafil, BAY38-9456)']}], 'interventions': [{'name': 'Levitra (Vardenafil, BAY38-9456)', 'type': 'DRUG', 'description': 'Vardenafil 10mg orally on demand prior to intercourse', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}