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Sponsors and Collaborators: |
Bayer GlaxoSmithKline Schering-Plough |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00655629 |
This study investigates the safety and efficacy of a new dosage form of vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
Condition | Intervention | Phase |
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Erectile Dysfunction |
Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo ODT |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-Dose, Double-Blind, Randomized Multi-Center Trial |
Enrollment: | 316 |
Study Start Date: | April 2008 |
Study Completion Date: | February 2009 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Levitra (Vardenafil, BAY38-9456)
Subjects will receive 12 weeks of PRN treatment with vardenafil 10 mg ODT or matching placebo ODT
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Arm 2: Placebo Comparator |
Drug: Placebo ODT
Subjects will receive 12 weeks of PRN treatment with vardenafil 10 mg ODT or matching placebo ODT
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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:
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
Study ID Numbers: | 12094 |
Study First Received: | April 4, 2008 |
Last Updated: | March 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00655629 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Erectile Dysfunction |
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 |