Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile Dysfunction
Phase 3
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00658177
- 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
- 463
Inclusion Criteria
- Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
- History of unresponsiveness to sildenafil
- Stable sexual relationship for > 6 month.
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 US Product Information
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 12 weeks
- Secondary Outcome Measures
Name Time Method Internation Index of Erectile Function-Erectile Function domain 12 weeks Sexual Encounter Profile Question 3 12 weeks Safety and tolerability 12 weeks