Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT00645268
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2008-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Double-blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Sildenafil on the As-Needed Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, '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', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2008-03-20', 'studyFirstSubmitQcDate': '2008-03-20', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The IIEF Erectile Function (EF) Domain score', 'timeFrame': 'Week 4'}], 'secondaryOutcomes': [{'measure': 'Intercourse success rate based on Event Logs', 'timeFrame': 'continuous'}, {'measure': 'Ability to obtain an erection hard enough to attempt sexual intercourse post dose of sildenafil', 'timeFrame': 'continuous'}, {'measure': 'Responses to the Self-Esteem And Relationship (SEAR) Questionnaire (including individual domain scores for the Sexual Activity, Self-Esteem And Relationship domains)', 'timeFrame': 'Week 16'}, {'measure': 'Responses to International Index of Erectile Function (IIEF) and secondary IIEF Domain scores (Orgasm; Desire; Intercourse Satisfaction; Overall Satisfaction)', 'timeFrame': 'Week 16'}, {'measure': 'Reponses to the Global Efficacy Assessment Questions', 'timeFrame': 'Week 16'}, {'measure': 'Flow mediated brachial artery dilation (FMD) as an index of generalized endothelial function', 'timeFrame': 'Week 4, 6, and 16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481146&StudyName=A%20Multicenter%2C%20Double-blind%20Study%20to%20Evaluate%20the%20Effect%20of%20Pretreatment%20With%20a%20Daily%20Dose%20of%20sildenafil%20on%20the%20As-Needed%20Efficacy%20o', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "To determine the effect on erectile function in a population of type 2 diabetic men with erectile dysfunction who have undergone the following treatment regimen: pre-treatment with a daily dose of double-blind sildenafil versus placebo for 4 weeks (Phase I) followed by an as-needed, flexible-dose, open-label treatment phase with sildenafil for 12 weeks (Phase II). To assess safety and tolerability of this dosing regimen and to investigate its effects on endothelial function and subject's responses to the Self-Esteem And Relationship (SEAR) questionnaire."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients had a documented clinical diagnosis of erectile dysfunction, a sexual partner for the duration of the study, and have a HbAlc of less than or equal to 10 at screening. Type 2 diabetic patients currently on insulin or on combination therapy with an oral hypoglycemic agent were not excluded.\n\nExclusion Criteria:\n\nExcluded were subjects who had taken more than 6 doses of any PDE5 inhibitor and/or had taken their last dose less than 4 weeks prior to the screening visit; subjects with resting sitting and/or standing hypotension (BP \\< 90/50mmHg) or hypertension (BP \\> 170/110mmHg); and subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation in the last 3 months.'}, 'identificationModule': {'nctId': 'NCT00645268', 'briefTitle': 'A Multicenter, Double-blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Sildenafil on the As-Needed Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicenter, Double-blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Viagra® (Sildenafil Citrate) on the PRN Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'A1481146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'interventionNames': ['Drug: sildenafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: placebo']}, {'type': 'OTHER', 'label': 'Open-Label Arm', 'interventionNames': ['Drug: sildenafil']}], 'interventions': [{'name': 'sildenafil', 'type': 'DRUG', 'description': 'In the double-blind phase, patients received sildenafil 50 mg once daily during Week 1 (7 doses), followed by a daily dose of sildenafil 100 mg during the next 3 weeks.', 'armGroupLabels': ['Arm 1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'In the double-blind phase, patients received placebo once daily during Week 1 (7 doses), followed by a daily dose of placebo during the next 3 weeks.', 'armGroupLabels': ['Arm 2']}, {'name': 'sildenafil', 'type': 'DRUG', 'description': "Eligible subjects then entered an open-label phase during which all subjects received sildenafil 50 mg as needed for sexual activity for the next 2 weeks, which could be titrated to either 25 mg or 100 mg based on the investigator's assessment of efficacy and tolerability, for 10 weeks (12 weeks total).", 'armGroupLabels': ['Open-Label Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90212', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United 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form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}