Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-31 @ 10:12 AM
Study NCT ID:
NCT05446493
Status:
COMPLETED
Last Update Posted:
2022-07-06
First Post:
2022-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000068581', 'term': 'Tadalafil'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-05', 'studyFirstSubmitDate': '2022-01-05', 'studyFirstSubmitQcDate': '2022-07-05', 'lastUpdatePostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum YKL-40 and platelets indices in erectile dysfunction', 'timeFrame': '3 months', 'description': 'Measurement of YKL-40 and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil.'}], 'secondaryOutcomes': [{'measure': 'Effect of tadalafil on Erectile dysfucntion patients', 'timeFrame': '3 months', 'description': 'To show the therapeutic effect of tadalafil in dose 5 mg daily on Erectile dysfucntion patients and assess their response by international index of erectile function (IIEF-5)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction', 'Erectile Dysfunction With Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The aim of this current study is to estimate serum level of YKL-40, serum total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic patients with ED.\n\nExclusion Criteria:\n\n* Patients with history of pelvic trauma.\n* Patients with major pelvic surgical intervention.\n* Patients with hypogonadism and hyperprolactinemia.\n* Patients with chronic liver disease.\n* Patients with cardio vascular system diseases.\n* History of chronic intake of central nervous system, anti androgen drugs or other drugs as Tramadol.\n* Smokers patients.\n* Patients with non-vasculogenic Erectile dysfunction.'}, 'identificationModule': {'nctId': 'NCT05446493', 'briefTitle': 'Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University'}, 'officialTitle': 'Assessment of Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction', 'orgStudyIdInfo': {'id': '346/3/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tadalafil group', 'description': 'Each patient will be treated by tadalafil 5mg daily for 3months', 'interventionNames': ['Drug: Tadalafil 5mg']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Estimation of serum YKL-40, platelet indices and serum total testosterone in healthy individuals in camparing with tadalafil group'}], 'interventions': [{'name': 'Tadalafil 5mg', 'type': 'DRUG', 'description': '* Estimate serum level of serum YKL-40, total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3months.\n* Penile color Doppler ultrasound examination before and after treatment', 'armGroupLabels': ['Tadalafil group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'Aswan university', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Mohamed Amer Ahmed Abdellatif', 'investigatorAffiliation': 'Aswan University'}}}}