Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction
Phase 3
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00661596
- Lead Sponsor
- Bayer
- Brief Summary
Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 129
Inclusion Criteria
- Age: 18 years and older
- Males with erectile dysfunction
- Stable heterosexual relationship
Exclusion Criteria
- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- Nitrate use
- Other exclusion criteria apply acc. to 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 International Index of Erectile Function - Erectile Function Domain 12 weeks
- Secondary Outcome Measures
Name Time Method Other diary based variables 12 weeks Safety and tolerability 12 weeks Global Assessment Questionnaire 12 weeks IIEF-EF domain score 12 weeks