Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT01106118
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2010-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Effectiveness of Vardenafil in Patients With Erectile Dysfunction and Metabolic Syndrome in Daily Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Jordan', 'Libya', 'Vietnam', 'Yemen']}, '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': 2289}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-14', 'studyFirstSubmitDate': '2010-04-16', 'studyFirstSubmitQcDate': '2010-04-16', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of patients with a clinically relevant, intra-individual improvement in erectile function defined as an increase of 4 points in the erectile function domain of the International Index of Erectile Function (IIEF)', 'timeFrame': 'After approx 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeks', 'timeFrame': 'After approx. 12 weeks'}, {'measure': 'Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks', 'timeFrame': 'After approx. 12 weeks'}, {'measure': 'Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks', 'timeFrame': 'After approx. 12 weeks'}, {'measure': 'Optional by country, the effect of vardenafil on health-related quality of life (HRQoL) using the Aging Males Symptoms (AMS) Scale', 'timeFrame': 'After approx. 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '27151768', 'type': 'RESULT', 'citation': 'Shabsigh R, Mattern A; REVITALISE Study Group. REVITALISE: A Large Observational Study Assessing the Safety and Effectiveness of Vardenafil in Men With Erectile Dysfunction and Metabolic Syndrome. Sex Med. 2016 Sep;4(3):e135-44. doi: 10.1016/j.esxm.2016.03.027. Epub 2016 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'The primary goal of this international non-interventional study is to investigate the therapeutic effectiveness of vardenafil (film-coated tablet) in Erectile Dysfunction patients with the Metabolic Syndrome in daily clinical practice. It will include a large number of patients with various underlying conditions with different cultural and demographic backgrounds from different geographic areas.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Erectile Dysfunction (ED) patient who has newly been prescribed vardenafil (Levitra film-coated tablet) in accordance with the terms of the local marketing authorization.\n* Diagnosis of erectile dysfunction at the discretion of the physician, based on the patients ED history.\n* No use of any Phosphodiesterase Type 5 (PDE5) inhibitor within 1 month of study entry.\n* Documented Metabolic Syndrome (MetS), preferably according to the definition of the International Diabetes Foundation.\n\nExclusion Criteria:\n\n* Do not follow the contraindications and warnings of the Summary of Product Characteristics.'}, 'identificationModule': {'nctId': 'NCT01106118', 'acronym': 'REVITALISE', 'briefTitle': 'Therapeutic Effectiveness of Vardenafil in Patients With Erectile Dysfunction and Metabolic Syndrome in Daily Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Therapeutic Effectiveness of Vardenafil in ED Patients With the Metabolic Syndrome in Daily Clinical Practice', 'orgStudyIdInfo': {'id': '14872'}, 'secondaryIdInfos': [{'id': 'LV0901', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Vardenafil (Levitra, BAY38-9456)']}], 'interventions': [{'name': 'Vardenafil (Levitra, BAY38-9456)', 'type': 'DRUG', 'description': 'Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment as prescribed by physician', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Egypt'}, {'city': 'Many Locations', 'country': 'Israel'}, {'city': 'Many Locations', 'country': 'Kazakhstan'}, {'city': 'Many Locations', 'country': 'Kyrgyzstan'}, {'city': 'Many Locations', 'country': 'Lebanon'}, {'city': 'Many Locations', 'country': 'Russia'}, {'city': 'Many Locations', 'country': 'Saudi Arabia'}, {'city': 'Many Locations', 'country': 'Singapore'}, {'city': 'Many Locations', 'country': 'South Korea'}, {'city': 'Many Locations', 'country': 'Ukraine'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}