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Sponsors and Collaborators: |
Bayer GlaxoSmithKline |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00682019 |
The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.
Condition | Intervention | Phase |
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Erectile Dysfunction |
Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen Compared to Placebo in Subjects With Erectile Dysfunction |
Enrollment: | 383 |
Study Start Date: | December 2003 |
Study Completion Date: | August 2004 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Levitra (Vardenafil, BAY38-9456)
5mg, 10mg or 20mg taken 8 hours before sexual intercourse
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Arm 2: Placebo Comparator |
Drug: Placebo
matching placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Therapeutic Area Head ( Bayer HealthCare AG ) |
Study ID Numbers: | 100493 |
Study First Received: | April 18, 2008 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00682019 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 Genital Diseases, Male Erectile Dysfunction |
Sexual Dysfunctions, Psychological Phosphodiesterase Inhibitors Vardenafil Sexual Dysfunction, Physiological Molecular Mechanisms of Pharmacological Action Mental Disorders |
Enzyme Inhibitors Genital Diseases, Male Sexual and Gender Disorders Erectile Dysfunction Pharmacologic Actions |