A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.
Phase 4
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00668096
- Lead Sponsor
- Bayer
- Brief Summary
The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 260
Inclusion Criteria
- Males with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance
- Heterosexual relationship for more than 6 months
- Partner willing to complete the TSS
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 according to the Summary of Product Characteristics
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 Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign. 16 weeks
- Secondary Outcome Measures
Name Time Method Treatment Satisfaction Scale 16 weeks Other patient diary based variables 16 weeks Safety and tolerability 16 weeks International Index of Erectile Function 16 weeks