Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction
Phase 2
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00656188
- Lead Sponsor
- Bayer
- Brief Summary
This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Placebo - Arm 1 Levitra (Vardenafil, BAY38-9456) -
- Primary Outcome Measures
Name Time Method Sexual Encounter Profile Question 2 12 weeks Erectile Function domain of the International Index of Erectile Function 12 weeks Sexual Encounter Profile Question 3 12 weeks
- Secondary Outcome Measures
Name Time Method Sexual Encounter Profile 2 12 weeks Reliability of maintenance 12 weeks Other subject diary based variables 12 weeks Safety and tolerability 12 weeks Global Assessment Question 12 weeks Erectile Function domain scores > 26 12 weeks Reliability of insertion 12 weeks