Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-04-08 @ 3:43 AM
Study NCT ID:
NCT00668135
Status:
COMPLETED
Last Update Posted:
2014-12-17
First Post:
2008-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 348}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-15', 'studyFirstSubmitDate': '2008-04-25', 'studyFirstSubmitQcDate': '2008-04-28', 'lastUpdatePostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Global Assessment Question', 'timeFrame': '12 weeks'}, {'measure': 'Other diary responses', 'timeFrame': '12 weeks'}, {'measure': 'Safety and tolerability', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erectile Dysfunction', 'Vardenafil'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 20 years and older- Males with erectile dysfunction\n* Stable heterosexual relationship Exclusion Criteria:\n* Primary hypoactive sexual desire\n* History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use\n* Other exclusion criteria apply according to the Summary of Product Characteristics'}, 'identificationModule': {'nctId': 'NCT00668135', 'briefTitle': 'Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Randomised, Double Blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Study to Evaluate the Efficacy and Tolerability of Vardenafil (BAY 38-9456) in Treatment of Male Erectile Dysfunction in Asia', 'orgStudyIdInfo': {'id': '10657'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Vardenafil (Levitra, BAY38-9456)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vardenafil (Levitra, BAY38-9456)', 'type': 'DRUG', 'description': 'Vardenafil 10 mg orally on demand prior to intercourse', 'armGroupLabels': ['Arm 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '10430', 'city': 'Jakarta', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '47500', 'city': 'Petlaing Jaya', 'state': 'Salangor', 'country': 'Malaysia'}, {'city': 'Kuching', 'state': 'Sarawak', 'country': 'Malaysia', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}, {'zip': '51200', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '150', 'city': 'Manila', 'country': 'Philippines', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'country': 'Philippines', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}