LEVITRA® 20mg Special Drug Use Investigation (Long-term)
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Vardenafil, (Levitra, BAY38-9456)
- Registration Number
- NCT00909233
- Lead Sponsor
- Bayer
- Brief Summary
This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1221
Inclusion Criteria
- This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Vardenafil, (Levitra, BAY38-9456) -
- Primary Outcome Measures
Name Time Method Efficacy of patients with LEVITRA treatment After 6 months
- Secondary Outcome Measures
Name Time Method LEVITRA treatment improved the patient's erection After 6 months LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse After 6 months Reporting a second successful intercourse within 24 hours of dosing After 6 months Tolerability of patients with LEVITRA treatment After 6 months Patients prefer LEVITRA over last Erectile Dysfunction treatment After 6 months