Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil
Phase 3
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00661297
- Lead Sponsor
- Bayer
- Brief Summary
Study to investigate the efficacy and safety of Vardenafil
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 523
Inclusion Criteria
- Heterosexual males
- >/= 18 years old with ED for more than six months
- Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation
Exclusion Criteria
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
- Nitrate therapy
- Other exclusion criteria apply according to the Summary of Product Characteristics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Levitra (Vardenafil, BAY38-9456) - Arm 2 Placebo -
- Primary Outcome Measures
Name Time Method Sexual Encounter Profile question 2 (SEP 2) 12 weeks
- Secondary Outcome Measures
Name Time Method Safety and Tolerability 12 weeks Sexual Encounter Profile question 3 (SEP 3) 12 weeks International Index of Erectile Function (IIEF) - EF (Erectile Function) domain 12 weeks