Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Bayer |
---|---|
Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00678704 |
The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.
Condition | Intervention | Phase |
---|---|---|
Erectile Dysfunction Diabetes Mellitus |
Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled, Double-Blind, Multi-Centre, Parallel Group Study to Investigate the Efficacy and Safety of BAY 38-9456 in Males With Diabetes Suffering From Erectile Dysfunction |
Enrollment: | 840 |
Study Start Date: | January 2004 |
Study Completion Date: | November 2004 |
Arms | Assigned Interventions |
---|---|
Arm 3: Placebo Comparator
n/a
|
Drug: Placebo
Placebo tablet prior to intercourse on demand
|
Arm 1: Experimental
n/a
|
Drug: Levitra (Vardenafil, BAY38-9456)
BAY 38-9456 10 mg tablet prior to intercourse on demand
|
Arm 2: Experimental
n/a
|
Drug: Levitra (Vardenafil, BAY38-9456)
BAY 38-9456 20 mg tablet prior to intercourse on demand
|
Ages Eligible for Study: | 20 Years to 64 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | ( Bayer HealthCare AG, Therapeutic Area Head ) |
Study ID Numbers: | 100607 |
Study First Received: | April 1, 2008 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00678704 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency; United States: Food and Drug Administration |
Vardenafil PDE5 inhibitor Erectile Dysfunction Diabetes Mellitus Sexual Dysfunction |
Sexual Dysfunctions, Psychological Vardenafil Sexual Dysfunction, Physiological Metabolic Diseases Mental Disorders Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Genital Diseases, Male Glucose Metabolism Disorders Erectile Dysfunction |
Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Sexual and Gender Disorders Pharmacologic Actions |