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Clinical Trial Details

Trial ID: L3747
Source ID: NCT00645268
Associated Drug: Sildenafil
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
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Erectile Dysfunction|Diabetes Mellitus, Type 2
Interventions: DRUG: sildenafil|DRUG: placebo|DRUG: sildenafil
Outcome Measures: Primary: The IIEF Erectile Function (EF) Domain score, Week 4 | Secondary: Intercourse success rate based on Event Logs, continuous|Ability to obtain an erection hard enough to attempt sexual intercourse post dose of sildenafil, continuous|Responses to the Self-Esteem And Relationship (SEAR) Questionnaire (including individual domain scores for the Sexual Activity, Self-Esteem And Relationship domains), Week 16|Responses to International Index of Erectile Function (IIEF) and secondary IIEF Domain scores (Orgasm; Desire; Intercourse Satisfaction; Overall Satisfaction), Week 16|Reponses to the Global Efficacy Assessment Questions, Week 16|Flow mediated brachial artery dilation (FMD) as an index of generalized endothelial function, Week 4, 6, and 16
Sponsor/Collaborators: Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2002-12
Completion Date: 2004-01
Results First Posted:
Last Update Posted: 2021-02-01
Locations: Pfizer Investigational Site, Huntsville, Alabama, 35801, United States|Pfizer Investigational Site, Phoenix, Arizona, 85006, United States|Pfizer Investigational Site, Beverly Hills, California, 90212, United States|Pfizer Investigational Site, Duarte, California, 91010, United States|Pfizer Investigational Site, La Jolla, California, 92037, United States|Pfizer Investigational Site, La Jolla, California, 92093, United States|Pfizer Investigational Site, Laguna Woods, California, 92653, United States|Pfizer Investigational Site, Los Angeles, California, 90048, United States|Pfizer Investigational Site, San Diego, California, 92161, United States|Pfizer Investigational Site, Norwalk, Connecticut, 06850, United States|Pfizer Investigational Site, Waterbury, Connecticut, 06708, United States|Pfizer Investigational Site, New Albany, Indiana, 47150, United States|Pfizer Investigational Site, Overland Park, Kansas, 66211, United States|Pfizer Investigational Site, New Orleans, Louisiana, 70112, United States|Pfizer Investigational Site, Baltimore, Maryland, 21224, United States|Pfizer Investigational Site, Baltimore, Maryland, 21287, United States|Pfizer Investigational Site, Boston, Massachusetts, 02215, United States|Pfizer Investigational Site, Minneapolis, Minnesota, 55416, United States|Pfizer Investigational Site, Richmond Heights, Missouri, 63117, United States|Pfizer Investigational Site, Saint Louis, Missouri, 63104, United States|Pfizer Investigational Site, Buffalo, New York, 14209, United States|Pfizer Investigational Site, Medford, Oregon, 97504, United States|Pfizer Investigational Site, Portland, Oregon, 97201, United States|Pfizer Investigational Site, San Antonio, Texas, 78217, United States|Pfizer Investigational Site, San Antonio, Texas, 78229-3894, United States|Pfizer Investigational Site, Kirkland, Washington, 98034, United States|Pfizer Investigational Site, Tacoma, Washington, 98023, United States|Pfizer Investigational Site, Tacoma, Washington, 98405, United States|Pfizer Investigational Site, Calgary, T2N2T9, Canada
URL: https://clinicaltrials.gov/show/NCT00645268

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress