Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-09 @ 9:38 PM
Study NCT ID:
NCT00678704
Status:
COMPLETED
Last Update Posted:
2014-12-19
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAY38-9456 - Pivotal Trial for Diabetes Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 790}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-18', 'studyFirstSubmitDate': '2008-04-01', 'studyFirstSubmitQcDate': '2008-05-14', 'lastUpdatePostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15', 'timeFrame': 'At 12 weeks after start of study drug administration using data at LOCF to account for dropouts'}], 'secondaryOutcomes': [{'measure': 'The Global Assessment Question', 'timeFrame': 'At 4, 8, 12 weeks after start of study drug administration and LOCF'}, {'measure': 'The IIEF EF domain score', 'timeFrame': 'At 4, 8, 12 weeks after start of study drug administration'}, {'measure': 'IIEF domain scores other than the EF domain score[intercourse satisfaction (Q6 to Q8), overall satisfaction (Q13, Q14), orgasmic function (Q9, Q10), sexual desire (Q11, Q12)]', 'timeFrame': 'At 4, 8, 12 weeks after start of study drug administration and LOCF'}, {'measure': 'Scores of Questions 1 to 15 on the IIEF Questionnaire', 'timeFrame': 'At 4, 8, 12 weeks after start of study drug administration and LOCF'}, {'measure': "Patient's diary response concerning hardness of erection, maintenance of erection, satisfaction with overall hardness of erection, ability of insertion, overall satisfaction with sexual experience and ejaculation", 'timeFrame': 'At 4, 8, 12 weeks after start of study drug administration and LOCF'}, {'measure': 'Safety data', 'timeFrame': 'Throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vardenafil', 'PDE5 inhibitor', 'Erectile Dysfunction', 'Diabetes Mellitus', 'Sexual Dysfunction'], 'conditions': ['Erectile Dysfunction', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)\n* Diabetes for more than 3 years\n\nExclusion Criteria:\n\n* Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose\n* Spinal cord injury\n* History of surgical prostatectomy (excluding TURP)\n* Patients with an HbA1c \\> 12% at Visit 1\n* Use of nitrates\n* Use of potent CYP3a4 inhibitors\n* Severe liver disease\n* Presence of Peyronie's Disease"}, 'identificationModule': {'nctId': 'NCT00678704', 'briefTitle': 'BAY38-9456 - Pivotal Trial for Diabetes Patient', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blind, Multi-centre, Parallel Group Study to Investigate the Efficacy and Safety of BAY 38-9456 in Males With Diabetes Suffering From Erectile Dysfunction', 'orgStudyIdInfo': {'id': '100607'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Levitra (Vardenafil, BAY38-9456)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: Levitra (Vardenafil, BAY38-9456)']}], 'interventions': [{'name': 'Levitra (Vardenafil, BAY38-9456)', 'type': 'DRUG', 'description': 'BAY 38-9456 10 mg tablet prior to intercourse on demand', 'armGroupLabels': ['Arm 1']}, {'name': 'Levitra (Vardenafil, BAY38-9456)', 'type': 'DRUG', 'description': 'BAY 38-9456 20 mg tablet prior to intercourse on demand', 'armGroupLabels': ['Arm 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet prior to intercourse on demand', 'armGroupLabels': ['Arm 3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}