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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00665496 |
This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.
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, Double Dummy, Parallel Group, Multi-Center Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction. |
Enrollment: | 870 |
Study Start Date: | June 2003 |
Study Completion Date: | November 2003 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg and 20 mg orally once a day as needed
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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:
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Therapeutic Area Head ( Bayer Healthcare AG ) |
Study ID Numbers: | 100492 |
Study First Received: | April 23, 2008 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00665496 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Erectile Dysfunction Vardenafil Onset of action |
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 |