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Sponsors and Collaborators: |
Bayer GlaxoSmithKline |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00663130 |
Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED
Condition | Intervention | Phase |
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Erectile Dysfunction |
Drug: Levitra (Vardenafil, BAY38-9456) Drug: Tadalafil |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Active-Controlled Study Evaluating the Efficacy of Vardenafil Versus Tadalafil When Intercourse is Attempted Within 45 Minutes of Administration in Subjects With Erectile Dysfunction |
Enrollment: | 759 |
Study Start Date: | April 2004 |
Study Completion Date: | July 2004 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse
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Arm 2: Active Comparator |
Drug: Tadalafil
Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse
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Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Medical Affairs Therapeutic Area Head ( Bayer Healthcare AG ) |
Study ID Numbers: | 11333 |
Study First Received: | April 17, 2008 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00663130 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Erectile Dysfunction Vardenafil |
Sexual Dysfunctions, Psychological Phosphodiesterase Inhibitors Vardenafil Sexual Dysfunction, Physiological |
Mental Disorders Tadalafil Genital Diseases, Male Erectile Dysfunction |
Sexual Dysfunctions, Psychological Phosphodiesterase Inhibitors Vardenafil Sexual Dysfunction, Physiological Molecular Mechanisms of Pharmacological Action Mental Disorders |
Tadalafil Enzyme Inhibitors Genital Diseases, Male Sexual and Gender Disorders Erectile Dysfunction Pharmacologic Actions |