Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-29 @ 8:01 PM
Study NCT ID:
NCT05466695
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing The Effect of Tadalafil 5 mg/Day to Sildenafil 25 mg/Day on Neutrophil-Lymphocyte and Platelet-Lymphocyte Ratios in Erectile Dysfunction Patients; and Comparison of Clinical Response
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'}, {'id': 'D000068677', 'term': 'Sildenafil Citrate'}], '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'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D011687', 'term': 'Purines'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will use daily tadalafil 5 mg or daily sildenafil 25 mg 4. Assessment of the grade of erectile dysfunction using international index of erectile function-5.The patients whose international Index of Erectile Function-5 (IIEF-5) scores varied between 5-7 are considered to have severe and 8-16 are considered to have moderate and 17-21 are considered to have mild erectile dysfunction.\n\n2\\. Blood sample will be obtained before and after 2 months of medical treatment to measure neutrophil-lymphocyte and platelet-lymphocyte ratios.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-16', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-16', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of tadalafil on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .', 'timeFrame': '2 months', 'description': 'Effect of daily tadalfil 5 mg on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios'}, {'measure': 'Effect of sildenafil on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .', 'timeFrame': '2 months', 'description': 'Effect of sildenafil 25 mg daily on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction and Neutrophil Lymphocyte Ratio']}, 'descriptionModule': {'briefSummary': '1- To evaluate the effect of using tadalafil 5mg/day or sildenafil 25mg/day in the treatment on these ratios and its clinical effect in erectile dysfunction patients.', 'detailedDescription': 'Erectile dysfunction (ED) is an inability to provide adequate erection to initiate or maintain any sexual activity. The ED prevalence in adult males is approximately 20%. Cardiovascular diseases, diabetes mellitus(DM), chronic systemic diseases, smoking and obesity are among the aetiology of ED .In recent years, publications indicating that active inflammatory processes cause ED are increasing. In these studies where neutrophil- lymphocyte (NLR) and platelet-lymphocyte ratios (PLR) were used as signs of inflammation, a significant relationship was found between diseases with these proportions .Neutrophil-to-lymphocyte ratio (NLR) is a simple parameter to assess easily the inflammatory status of a subject. It has proven its usefulness in the stratification of mortality in major cardiac events , as a strong prognostic factor in several types of cancers , or as a predictor and a marker of inflammatory or infectious pathologies (such is pediatric appendicitis) and postoperative complications. Through enhanced production of cytokines and expression of cellular adhesion molecules, the dysfunctional endothelium promotes inflammation within the vascular wall and sets the stage for initiation and progression of atherosclerotic lesions in both penile vasculature and in peripheral and coronary blood vessels. It has been shown that patients with vasculogenic ED have increased inflammatory activation compared to subjects without ED.There are numerous studies suggesting that phosphodiesterase-5(PDE-5) inhibitors, which are the first-line therapy of ED, might be effective in reversing generalized endothelial dysfunction. Chronic treatment restores endothelium-dependent relaxations at various sites of the vascular tree, even up to one week after cessation of the treatment . Previous studies reported a chronic effect of sildenafil and tadalafil on endothelial function and pro-inflammatory markers/mediators including intercellular and vascular cell adhesion molecules-1 (ICAM-1 and VCAM-1, respectively), high sensitivity C-reactive protein (hsCRP), and interleukin-6'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients with mild,moderate and severe erectile dysfunction.\n* Age from 25 to 60 years.\n\nExclusion Criteria:\n\n* ยท Severe uncontrolled medical condition(DM,HTN).\n\n * Patients under treatment with sublingual nitrate .\n * Patients with blood diseases that affect sexual function (Leukaemia).\n * Patients using cytotoxic drugs or immunosuppressive drugs.\n * Single patient.'}, 'identificationModule': {'nctId': 'NCT05466695', 'briefTitle': 'Comparing The Effect of Tadalafil 5 mg/Day to Sildenafil 25 mg/Day on Neutrophil-Lymphocyte and Platelet-Lymphocyte Ratios in Erectile Dysfunction Patients; and Comparison of Clinical Response', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparing The Effect of Tadalafil 5 mg/Day to Sildenafil 25 mg/Day on Neutrophil-Lymphocyte and Platelet-Lymphocyte Ratios in Erectile Dysfunction Patients; and Comparison of Clinical Response', 'orgStudyIdInfo': {'id': 'oral PDI5 and Blood components'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tadalfil group', 'description': 'Patients will use daily tadalafil 5 mg for 2 months', 'interventionNames': ['Drug: Tadalafil 5mg/sildenafil 25 mg']}, {'type': 'EXPERIMENTAL', 'label': 'sildenafil group', 'description': 'Patients will use daily sildenafil 25 mg for 2 months', 'interventionNames': ['Drug: Tadalafil 5mg/sildenafil 25 mg']}], 'interventions': [{'name': 'Tadalafil 5mg/sildenafil 25 mg', 'type': 'DRUG', 'otherNames': ['blood sample before and after 2 months of medical tratment'], 'description': 'patients will use daily tadalafil or daily sildenafil for 2 months blood sample will be obtained before and after 2 months and also IIEF-5 score for clinical response', 'armGroupLabels': ['sildenafil group', 'tadalfil group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'AssiutU', 'role': 'CONTACT', 'email': 'vpgrad@aun.edu.eg', 'phone': '+208822080150'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mohamed Diab Mohamed', 'role': 'CONTACT', 'email': 'md01147169166@gmail.com', 'phone': '01501501772'}, {'name': 'Hisham diab gaber', 'role': 'CONTACT', 'email': 'hishamdiabg@yahoo.com', 'phone': '01009535577'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident physician', 'investigatorFullName': 'mohamed diab mohamed ramadan', 'investigatorAffiliation': 'Assiut University'}}}}