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Sponsors and Collaborators: |
Bayer GlaxoSmithKline |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00657033 |
Study to investigate the efficacy and safety of vardenafil flexible dose versus placebo in males with erectile dysfunction, and their female partners' sexual quality of life.
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, Multi-Center Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction, and Their Female Partners' Sexual Quality of Life. |
Enrollment: | 229 |
Study Start Date: | October 2003 |
Study Completion Date: | August 2004 |
Arms | Assigned Interventions |
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Arm 1: Experimental
n/a
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Drug: Levitra (Vardenafil, BAY38-9456)
BAY 38-9456 (Vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.
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Arm 2: Experimental
n/a
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Drug: Placebo
Identical placebo tablets will be matched for each vardenafil dosage and will be indistinguishable from active treatment
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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:
A) Previous or current medical conditions
Other Exclusion Criteria:
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | ( Bayer Healthcare Pharmaceuticals Inc., Therapeutic Area Head ) |
Study ID Numbers: | 100519 |
Study First Received: | April 9, 2008 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00657033 |
Health Authority: | United States: Food and Drug Administration |
Erectile Dysfunction |
Sexual Dysfunctions, Psychological Vardenafil Sexual Dysfunction, Physiological Mental Disorders |
Quality of Life Genital Diseases, Male Erectile Dysfunction |
Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Sexual and Gender Disorders Pharmacologic Actions |