Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-07 @ 2:33 PM
Study NCT ID:
NCT00547092
Status:
COMPLETED
Last Update Posted:
2007-10-22
First Post:
2007-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 386}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-18', 'studyFirstSubmitDate': '2007-10-18', 'studyFirstSubmitQcDate': '2007-10-18', 'lastUpdatePostDateStruct': {'date': '2007-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preference Assessment measured by the Treatment Preference Question', 'timeFrame': '26 weeks'}], 'secondaryOutcomes': [{'measure': 'Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary.', 'timeFrame': '0, 12, and 26 weeks'}, {'measure': 'Assess sexual encounters attributes measured by the PAIRS.', 'timeFrame': '0, 12, and 26 weeks'}, {'measure': 'Measure adverse events through the Side Effect Question.', 'timeFrame': '12 and 26 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Impotence']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of erection problems\n* Never taken treatments known as PDE5 inhibitors for erection issues\n* Abstain from using any other erection treatments during the study\n* Anticipate a monogamous female sexual relationship\n* Must be able to make required sexual intercourse attempts\n\nExclusion Criteria:\n\n* History of other primary sexual disorder\n* Treatment with nitrates\n* Have a penile implant or clinically significant penile deformity\n* History of certain heart problems\n* Do not meet certain lab value reference ranges'}, 'identificationModule': {'nctId': 'NCT00547092', 'briefTitle': 'Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multicenter Open-Label Study to Determine Treatment Preference of Tadalafil (IC351, LY450190) or Sildenafil Citrate in the Oral Treatment of Erectile Dysfunction', 'orgStudyIdInfo': {'id': '7002'}, 'secondaryIdInfos': [{'id': 'H6D-MC-LVFL'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'tadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks.', 'interventionNames': ['Drug: tadalafil']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'sildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks.', 'interventionNames': ['Drug: sildenafil']}], 'interventions': [{'name': 'tadalafil', 'type': 'DRUG', 'otherNames': ['LY450190', 'Cialis', 'IC351'], 'description': '10 mg or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)', 'armGroupLabels': ['1']}, {'name': 'sildenafil', 'type': 'DRUG', 'description': '25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ICOS Corporation', 'class': 'INDUSTRY'}]}}}