Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT00705861
Status:
COMPLETED
Last Update Posted:
2013-04-18
First Post:
2008-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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': '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': 'C518762', 'term': '2-(5-(4-(2-hydroxyethyl)piperazin-1-ylsulfonyl)-2-n-propoxyphenyl)-5-ethyl-7-n-propyl-3,5-dihydro-4H-pyrrolo(3,2-d)pyrimidin-4-one dihydrochloride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-16', 'studyFirstSubmitDate': '2008-06-24', 'studyFirstSubmitQcDate': '2008-06-25', 'lastUpdatePostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire', 'timeFrame': '0, 4, 8, 12week'}], 'secondaryOutcomes': [{'measure': 'the score from : 1) IIEF Q3 & Q4, 2) other domains of IIEF, 3) Sexual Encounter Profile(SEP)Q2 and Q3, 4) Life Satisfaction Checklist, 5) Global Efficacy Assessment Question(GEAQ)', 'timeFrame': '0, 4, 8, 12 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Erectile dysfunction', 'Diabetes Mellitus', 'SK3530'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of SK3530 on erectile dysfunction in Patients with Diabetes Mellitus.', 'detailedDescription': 'SK3530 is a potent and selective phosphdiesterase type 5(PDE 5) inhibitor developed for the treatment of erectile dysfunction(ED). Since ED is common in men with Diabetes Mellitus, it is important to determine the efficacy and safety of SK3530 on erectile dysfunction in Patients with Diabetes Mellitus.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of type 1 or type 2 diabetes.\n* Score below 25 from IIEF EF domain during 4 weeks of treatment run-in period.\n* Failure rate above 50% from sexual attempt above 4 during 4 weeks of treatment run-in period.\n\nExclusion Criteria:\n\n* Lab abnormality.\n* Uncontrolled diabetic mellitus(HbA1c \\> 12%).\n* High or low blood pressure, orthostatic hypotension.\n* Hyper- or hypo-thyroidism.'}, 'identificationModule': {'nctId': 'NCT00705861', 'briefTitle': 'Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'SK Chemicals Co., Ltd.'}, 'officialTitle': 'A 12 Week, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel Group, Fixed Dose Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'SK3530_DM_III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: SK3530']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo as a substitute of SK3530 100mg', 'armGroupLabels': ['1']}, {'name': 'SK3530', 'type': 'DRUG', 'otherNames': ['Mvix'], 'description': 'SK3530 100mg', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'SK Chemicals Co., Ltd', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Nam-Chul Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BNUH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SK Chemicals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}