Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
Study NCT ID:
NCT00143260
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2005-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose
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': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'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': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2005-08-31', 'studyFirstSubmitQcDate': '2005-08-31', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra.'}], 'secondaryOutcomes': [{'measure': 'Proportion (as above) of patients at various endpoints. Other questionnaires such as SEP, IIEF.'}]}, 'conditionsModule': {'conditions': ['Impotence']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481240&StudyName=Study+Of+Men+With+Mild+To+Moderate+Erectile+Dysfunction+To+Evaluate+The+Efficacy+Of+Viagra+8+Hours+Post%2DDose', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men 18-70 years of age\n* Documented clinical diagnosis of erectile dysfunction of at least 3 months duration.\n\nExclusion Criteria:\n\n* Subjects with penile implants\n* Subjects with a known history of retinitis pigmentosa.\n* Subjects, due to the requirement of 100 mg dosage, who are receiving concomitant treatment with the potent CYP3A4 inhibitor ritonavir.'}, 'identificationModule': {'nctId': 'NCT00143260', 'briefTitle': 'Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Multicenter Randomized Double-Blind, Placebo-Controlled, Fixed-Dose Parallel Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose - II', 'orgStudyIdInfo': {'id': 'A1481240'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Viagra (Sildenafil Citrate) 100 mg', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'city': 'Jeffersonville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.27757, 'lon': -85.73718}}, {'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Bay Shore', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.7251, 'lon': -73.24539}}, {'city': 'Kingston', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.92704, 'lon': -73.99736}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}