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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00665340 |
Assess the responsiveness of the Erection Quality Scale (EQS) to vardenafil HCl flexible dose therapy versus placebo in men with Erectile Dysfunction
Condition | Intervention | Phase |
---|---|---|
Erectile Dysfunction |
Drug: Placebo Drug: Levitra (Vardenafil, BAY38-9456) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Responsiveness of the Erectile Quality Scale (EQS) to Vardenafil HCl Flexible Dose Versus Placebo in Males With Erectile Dysfunction. |
Enrollment: | 219 |
Study Start Date: | July 2004 |
Study Completion Date: | January 2005 |
Arms | Assigned Interventions |
---|---|
Arm 1: Placebo Comparator
n/a
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Drug: Placebo
Matching placebo
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Arm 2: Experimental
n/a
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Drug: Levitra (Vardenafil, BAY38-9456)
5m, 10 mg and 20 mg 1 h prior to sexual intercourse
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This study was conducted to evaluate in adult men with erectile dysfunction (often called impotence), the effect of vardenafil HCl on the quality of their erections. Many men experience occasional erectile problems during their lives. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl. In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like the real drug but it is not.
It contains no active ingredients.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Phoenix, Arizona, United States, 85023 | |
United States, California | |
Newport Beach, California, United States, 92660 | |
Beverly Hills, California, United States, 90212 | |
Laguna Hills, California, United States, 92653 | |
United States, Colorado | |
Aurora, Colorado, United States, 80012 | |
United States, Connecticut | |
Trumbull, Connecticut, United States, 06611 | |
United States, Florida | |
Aventura, Florida, United States, 33180 | |
United States, New Jersey | |
Lawrenceville, New Jersey, United States, 08648 | |
United States, New York | |
Poughkeepsie, New York, United States, 12601 | |
United States, North Carolina | |
Wilmington, North Carolina, United States, 28412 | |
Statesville, North Carolina, United States, 28677 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | ( Bayer Healthcare Pharmaceuticals Inc., Therapeutic Area Head ) |
Study ID Numbers: | 11561 |
Study First Received: | April 18, 2008 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00665340 |
Health Authority: | United States: Food and Drug Administration |
Erectile Dysfunction Vardenafil |
Sexual Dysfunctions, Psychological Vardenafil Sexual Dysfunction, Physiological |
Mental Disorders Genital Diseases, Male Erectile Dysfunction |
Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Sexual and Gender Disorders Pharmacologic Actions |