Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT00547495
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 the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring 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'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 343}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, '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': 'Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to endpoint of various questions from the IIEF and SEP diary', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Impotence']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3 months history of erectile dysfunction (ED)\n* Anticipate a monogamous relationship with a female sexual partner\n* Be able to make minimum required sexual intercourse attempts\n* Abstain from using any other ED treatment\n\nExclusion Criteria:\n\n* Other primary sexual disorders\n* History of radical prostatectomy or other pelvic surgery that affected being able to have an erection\n* History of penile implant or clinically significant penile deformity.\n* Nitrate use\n* Certain heart problems'}, 'identificationModule': {'nctId': 'NCT00547495', 'briefTitle': 'Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Tadalafil Administered "On Demand" to Patients With Erectile Dysfunction', 'orgStudyIdInfo': {'id': '5139'}, 'secondaryIdInfos': [{'id': 'H6D-MC-LVDI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo tablet', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '5 mg tadalafil', 'interventionNames': ['Drug: tadalafil']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': '10 mg tadalafil', 'interventionNames': ['Drug: tadalafil']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': '20 mg tadalafil', 'interventionNames': ['Drug: tadalafil']}], 'interventions': [{'name': 'tadalafil', 'type': 'DRUG', 'otherNames': ['LY450190', 'Cialis', 'IC351'], 'description': '5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks', 'armGroupLabels': ['2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks', 'armGroupLabels': ['1']}, {'name': 'tadalafil', 'type': 'DRUG', 'otherNames': ['LY450190', 'Cialis', 'IC351'], 'description': '10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks', 'armGroupLabels': ['3']}, {'name': 'tadalafil', 'type': 'DRUG', 'otherNames': ['LY450190', 'Cialis', 'IC351'], 'description': '20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', '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': 43.06667, 'lon': 141.35}}], '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'}]}}}