BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
Phase 3
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00668057
- Lead Sponsor
- Bayer
- Brief Summary
This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 624
Inclusion Criteria
- Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
- Stable heterosexual relationship
Exclusion Criteria
- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
- Nitrate use
- Other exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 3 Levitra (Vardenafil, BAY38-9456) - Arm 4 Placebo - Arm 6 Placebo - Arm 1 Levitra (Vardenafil, BAY38-9456) - Arm 5 Placebo - Arm 2 Levitra (Vardenafil, BAY38-9456) -
- Primary Outcome Measures
Name Time Method Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15 12 weeks
- Secondary Outcome Measures
Name Time Method Safety and tolerability 12 weeks Erectile Function domain score of the International Index of Erectile Function 12 weeks Global Assessment Questionnaire 12 weeks