Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-05 @ 12:08 PM
Study NCT ID:
NCT04374994
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2020-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daily Avanafil for 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': 'C553414', 'term': 'avanafil'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-20', 'size': 224283, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-06T18:45', 'hasProtocol': True}, {'date': '2018-09-20', 'size': 70823, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-06T18:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-05-02', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measuring the degree of improvement in the IIEF-5 score', 'timeFrame': 'After 4 weeks treatment', 'description': "The ED male's clinical response to daily avanafil was subjectively assessed by measuring the degree of improvement in the International Index of Erectile Function scoring (IIEF-5 ) score"}], 'primaryOutcomes': [{'measure': 'The percentage of change of NO serum level from baseline to 4 weeks', 'timeFrame': 'After 4 weeks treatment', 'description': 'To calculate the percentage of change of Nitric oxide (NO)(in µmol/L) serum level from baseline to 4 weeks post-treatment with avanafil'}, {'measure': 'The percentage of change of cGMP serum level from baseline to 4 weeks', 'timeFrame': 'After 4 weeks treatment', 'description': 'To calculate the percentage of change of cyclic guanosine monophosphate (cGMP) (in pmol/ml) serum level from baseline to 4 weeks post-treatment with avanafil'}, {'measure': 'The percentage of change of ET1 serum level from baseline to 4 weeks', 'timeFrame': 'After 4 weeks treatment', 'description': 'To calculate the percentage of change of endothelin-1 (ET1) (in ng/L) serum level from baseline to 4 weeks post-treatment with avanafil'}], 'secondaryOutcomes': [{'measure': 'Comparing avanafil with placebo group regarding post-treatment NO serum levels and percentage of change from baseline.', 'timeFrame': 'After 4 weeks treatment', 'description': 'To compare avanafil with placebo group regarding post-treatment nitric oxide (NO) (in µmol/L) serum level and percentage of change from baseline.'}, {'measure': 'Comparing avanafil with placebo group regarding post-treatment cGMP serum levels and percentage of change from baseline.', 'timeFrame': 'After 4 weeks treatment', 'description': 'To compare avanafil with placebo group regarding posttreatment cyclic guanosine monophosphate (cGMP) (in pmol/ml) serum level and percentage of change from baseline.'}, {'measure': 'Comparing avanafil with placebo group regarding post-treatment ET1 serum levels and percentage of change from baseline.', 'timeFrame': 'After 4 weeks treatment', 'description': 'To compare avanafil with placebo group regarding post-treatment endothelin-1 (ET1) (in ng/L) serum level and percentage of change from baseline.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['erectile dysfunction', 'endothelial dysfunction', 'Avanafil'], 'conditions': ['Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '19236190', 'type': 'BACKGROUND', 'citation': 'Konstantinopoulos A, Giannitsas K, Athanasopoulos A, Spathas D, Perimenis P. The impact of daily sildenafil on levels of soluble molecular markers of endothelial function in plasma in patients with erectile dysfunction. Expert Opin Pharmacother. 2009 Feb;10(2):155-60. doi: 10.1517/14656560802678211.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators tried to study the effect of daily avanafil on the serum level of endothelial function markers, as well as its impact on the erectile function in males with erectile and endothelial dysfunction by comparing the results with controls who received placebo.', 'detailedDescription': "Avanafil is a highly selective and potent oral phosphodiesterase type 5 inhibitor (PDE5-I) . However, its impact on the soluble markers of endothelial function has not been investigated yet. This study was conducted to assess the effect of daily avanafil on the erectile function and endothelial markers' serum level. In this work we recruited males with erectile dysfunction and other diseases commonly associated with endothelial dysfunction. The investigators randomly treated patients with daily oral avanafil and the other patients with placebo. The investigators measured the International Index of Erectile Function -5 score (IIEF- 5) and the serum levels of markers of endothelial function at baseline and treatment."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men with clinical diagnosis of erectile dysfunction of any severity.\n* Should be associated with systemic disorders indicative of endothelial dysfunction\n\nExclusion Criteria:\n\n\\- Erectile dysfunction due to psychogenic causes, hypogonadism, or spinal cord injury.'}, 'identificationModule': {'nctId': 'NCT04374994', 'briefTitle': 'Daily Avanafil for Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Evaluation of the Clinical and Molecular Efficacy of Daily Avanafil in Egyptian Males With Erectile and Endothelial Dysfunction (Randomized Placebo-Controlled Study)', 'orgStudyIdInfo': {'id': '0105643'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intervention group', 'description': 'Males with sexual dysfunction who received daily avanafil tablets (50mg) for four weeks', 'interventionNames': ['Drug: Avanafil 50 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'Males with sexual dysfunction who received daily placebo tablets for four weeks', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Avanafil 50 MG', 'type': 'DRUG', 'description': 'Oral phosphodiesterase type 5 inhibitors', 'armGroupLabels': ['intervention group']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'lactose and maize starch, Egypt', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21500', 'city': 'Alexandria', 'state': 'Elazareta', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Alexandria University.', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Abdelaal Elkamshoushi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Alexandria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Because we will publish the study in a journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alexandria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Shimaa Ismail Abdelhamid, MD', 'investigatorAffiliation': 'University of Alexandria'}}}}