Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-24 @ 4:38 AM
Study NCT ID:
NCT00667966
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2008-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess Efficacy in Subjects With Traumatic Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], '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'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2008-04-24', 'studyFirstSubmitQcDate': '2008-04-27', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characteristics of responders and non responder with respect to the electrophysiological (skin sympathetic response, bulbocavernosus reflex and somatosensory and pudendal evoked potential), urodynamical and clinical (ASIA group) tests', 'timeFrame': '4 treatment days', 'description': 'Responders are defined as subjects with rigidity ≥ 60% in the base measured with RigiScan during at least 5 minutes after withdrawing the vibrator and/or finishing manual stimulation.'}], 'secondaryOutcomes': [{'measure': 'Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 10 mg dose of vardenafil or placebo', 'timeFrame': '4 treatment days'}, {'measure': 'Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 20 mg dose of vardenafil or placebo', 'timeFrame': '4 treatment days'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'Approximately 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinal cord injury', 'Urodynamic', 'Erectile dysfunction', 'Vardenafil'], 'conditions': ['Erectile Dysfunction', 'Spinal Cord Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}]}, 'descriptionModule': {'briefSummary': 'Assess efficacy of Vardenafil in patients with traumatic spinal cord injury'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men between 18 and 64 years old with stable cord injury (more than 6 months) who had erectile dysfunction according to the National Institutes if Health (NIH) after their traumatic spinal cord injury\n\nExclusion Criteria:\n\n* Primary hypoactive sexual desire\n* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month\n* Nitrate therapy'}, 'identificationModule': {'nctId': 'NCT00667966', 'acronym': 'LEMDE', 'briefTitle': 'Assess Efficacy in Subjects With Traumatic Spinal Cord Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Double-blind, Cross-over, Placebo Controlled Pilot Study to Characterize the Profile of Those Patients With Spinal Cord Injury Diagnosed by Electrophysiological, Urodynamic and Clinical (ASIA Group) Assessment Who May Respond to Vardenafil Treatment. (LEMDE)', 'orgStudyIdInfo': {'id': '11861'}, 'secondaryIdInfos': [{'id': '2004-005282-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vardenafil + Placebo', 'description': 'Subjects received single dose of 10 mg vardenafil followed by 20 mg vardenafil and then crossed over to 10 mg placebo followed by 20 mg placebo.', 'interventionNames': ['Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg', 'Drug: Placebo', 'Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo + Vardenafil', 'description': 'Subjects received single dose of 10 mg placebo followed by 20 mg placebo and then crossed over to 10 mg vardenafil followed by 20 mg vardenafil.', 'interventionNames': ['Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg', 'Drug: Placebo', 'Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg']}], 'interventions': [{'name': 'Vardenafil (Levitra, BAY 38-9456), 10 mg', 'type': 'DRUG', 'description': '10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.', 'armGroupLabels': ['Placebo + Vardenafil', 'Vardenafil + Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '10/20 mg placebo in sequence in respective arm', 'armGroupLabels': ['Placebo + Vardenafil', 'Vardenafil + Placebo']}, {'name': 'Vardenafil (Levitra, BAY 38-9456), 20 mg', 'type': 'DRUG', 'description': '20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.', 'armGroupLabels': ['Placebo + Vardenafil', 'Vardenafil + Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '45071', 'city': 'Toledo', 'state': 'Toledo', 'country': 'Spain', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}