Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT02943356
Status:
UNKNOWN
Last Update Posted:
2016-10-24
First Post:
2016-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Tadalafil on Erectile Dysfunction Treatment and QOL Improvement Effect (by SF-12) in Andropause Patients With 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-21', 'studyFirstSubmitDate': '2016-10-21', 'studyFirstSubmitQcDate': '2016-10-21', 'lastUpdatePostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change on SF-12 Score from baseline to week 8', 'timeFrame': 'week 0 to week 8', 'description': 'The comparison of change of Quality of Live at baseline and 8 week (SF-12)'}], 'secondaryOutcomes': [{'measure': 'Change on SF-12 Score from baseline to week 4', 'timeFrame': 'week 0 to week 4', 'description': 'The comparison of change of Quality of Life at baseline and 4 week (SF-12)'}, {'measure': 'Change on bioimpedance Analysis from baseline to week 8', 'timeFrame': 'week 0 to week 8', 'description': 'The comparison of change of bioimpedance Analysis at baseline and 8 week'}, {'measure': 'Change on IIEF-5 Score from baseline to week 4, week 8', 'timeFrame': 'week 0 to week 4, week 8', 'description': 'The comparison of score at baseline, 4 week and 8 week (IIEF-5)'}, {'measure': 'Change on free radical from baseline to week 4, week 8', 'timeFrame': 'week 0 to week 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction', 'Andropause']}, 'descriptionModule': {'briefSummary': 'Observational study to evaluate the effect of Tadalafil 5mg once daily on Erectile Dysfunction and QOL in Andropause patients with Erectile Dysfunction.\n\nPatients will be observed for 8weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Above 35 years men\n2. Approving ADAM questionnaire and andropause patients with symptoms under contents\n\n ; easily fatigue, decreased sexual desire, general weakness, decreasing memory ect.\n3. Patient with Erectile Dysfunction above 6 months\n4. International Index of Erectile Function(IIEF-5) score under 21\n5. Voluntarily one want to treatment with Tadalafil 5 mg daily\n6. Voluntarily one agree this study and write informed consent\n\nExclusion Criteria:\n\n1. Persons who have taken PDE-5 inhibitor within last one month for Erectile Dysfunction\n2. Persons who taken testosterone treatment within last one month\n3. Persons who be history of Myocardiac infarction\n4. The history of taken organic nitrate drug\n5. The history of cardiovascular disease\n\n * In myocardial infarction within the last 90 days was now\n * Unstable angina or angina pectoris during intercourse that occurred\n * New York Heart Association Class 2 during the last six months or more sever cardiac failure\n * Uncontrolled arrythmia, hypotension(\\<90/50mmHg), or uncontrolled blood pressure(\\>170/100mmHg)\n * Persons who have a stroke within the last six months\n6. Persons who have degrative retinal disease including Pigmentary retinites\n7. Formerly persons who have one eye blindness by Artery anterior ischemic optic neuropathy with or without taking PDE5 inhibitor.\n8. Persons who use inhibitor or agonist drug f Hepatic cytochrome P4503A4\n9. Persons who use alpha antagonist add antihypertensive drug\n10. Moderate liver or kidney failure\n11. Major psychiatric or personality disorder\n12. Persons have phobia trial drug\n13. Persons have invasive treatment of prostate gland\n14. Congenital anomaly of penis\n15. Galactose, Lactose, Glucose intolerance patient\n16. Research coordinators who are deemed unfit'}, 'identificationModule': {'nctId': 'NCT02943356', 'briefTitle': 'Effect of Tadalafil on Erectile Dysfunction Treatment and QOL Improvement Effect (by SF-12) in Andropause Patients With Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Observational Study to Evaluate the Effect of Tadalafil 5mg Once Daily on Erectile Dysfunction and QOL in Andropause Patients With Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'TEDQOL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tadalafil', 'description': 'Patients will be treated with Tadalafil for 8 weeks.', 'interventionNames': ['Drug: Tadalafil']}], 'interventions': [{'name': 'Tadalafil', 'type': 'DRUG', 'description': 'Patients will be treated with Tadalafil for 8 weeks', 'armGroupLabels': ['Tadalafil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Keun-Sang Yum, M.D., PhD', 'role': 'CONTACT', 'email': 'yks6303@catholic.ac.kr', 'phone': '82-31-820-3179'}], 'facility': "Uijeongbu St.Mary's Hospital", 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}], 'centralContacts': [{'name': 'Keun-Sang Yum, M.D., PhD', 'role': 'CONTACT', 'email': 'yks6303@catholic.ac.kr', 'phone': '8231-820-3179'}], 'overallOfficials': [{'name': 'Keun-Sang Yum, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Uijeongbu St. Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Keun-Sang Yum', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}