Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 6:21 AM
Study NCT ID:
NCT07081659
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2025-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
On-demand Silodosin 4mg vs Dapoxetine 60mg in Treatment of Primary Premature Ejaculation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D061686', 'term': 'Premature Ejaculation'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000097910', 'term': 'Ejaculatory Dysfunction'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital 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': 'C080598', 'term': 'dapoxetine'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-01', 'size': 341908, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-15T06:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2025-07-15', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intravaginal ejaculatory Latency time', 'timeFrame': '2 months', 'description': 'changes in latency time'}], 'secondaryOutcomes': [{'measure': 'side effects', 'timeFrame': '2 months', 'description': 'any side effects were recorded'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['premature ejaculation', 'sexual function', 'ejaculatory profile', 'latency time'], 'conditions': ['Premature (Early) Ejaculation']}, 'descriptionModule': {'briefSummary': 'Both Silodosin 4 mg and Dapoxetine 60 mg significantly improved IELT and sexual function scores in primary PE patients. However, Silodosin exhibited a more favorable tolerability profile with fewer side effects, making it a safer, clinically effective alternative.', 'detailedDescription': 'Dapoxetine 60 mg, the initial FDA-approved on-demand treatment for PE, which is a selective serotonin reuptake inhibitor (SSRI) . However, Silodosin 4 mg, an α1-adrenoceptor antagonist, has emerged as a promising alternative, particularly for patients dissatisfied with Dapoxetine . This investigation is designed to evaluate the efficacy and tolerability of Silodosin 4mg and Dapoxetine 60mg in the treatment of primary premature ejaculation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'male patients in heterosexual relation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heterosexual male\n* Sexually active\n* Aged 25 to 65 years old.\n* Primary premature ejaculation (IELT \\< 1 minute)\n* They had experienced PE for a minimum of 6 months\n\nExclusion Criteria:\n\n* Patients with a history of diabetes or\n* Uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) was precluded from the study.\n* Anatomic abnormalities of the penis or genital region,\n* Erectile dysfunction,\n* Chronic prostatitis,\n* Psychological disorder\n* Patients on anti-psychotic drugs.'}, 'identificationModule': {'nctId': 'NCT07081659', 'briefTitle': 'On-demand Silodosin 4mg vs Dapoxetine 60mg in Treatment of Primary Premature Ejaculation', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'On-demand Silodosin 4mg vs Dapoxetine 60mg in the Treatment of Primary Premature Ejaculation', 'orgStudyIdInfo': {'id': 'Ms13-3-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A', 'description': 'sildosin 4mg', 'interventionNames': ['Drug: sildosin 4mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'dapoxetine 60mg', 'interventionNames': ['Drug: dapoxetine 60mg']}], 'interventions': [{'name': 'sildosin 4mg', 'type': 'DRUG', 'description': 'ondemand sildosin 4mg', 'armGroupLabels': ['group A']}, {'name': 'dapoxetine 60mg', 'type': 'DRUG', 'description': 'ondemand dapoxetine 60mg', 'armGroupLabels': ['group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'Qalyubia Governorate', 'country': 'Egypt', 'facility': 'Benha faculty of medicine, urology department', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'it will be shared upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant professor', 'investigatorFullName': 'Hussein Shaher', 'investigatorAffiliation': 'Benha University'}}}}