Evaluation of Efficacy and Safety of Vardenafil in Patients With Erectile Dysfunction and Type 1 Diabetes
Phase 4
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00660998
- Lead Sponsor
- Bayer
- Brief Summary
Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 318
Inclusion Criteria
- Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
- Diabetes type 1
- 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 3 12 weeks Sexual Encounter Profile Question 2 12 weeks
- Secondary Outcome Measures
Name Time Method International Index of Erectile Function - Erectile Function Domain 12 weeks Safety and Tolerability 12 weeks