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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
GroupInterventionDescription
Group 1Vardenafil, (Levitra, BAY38-9456)-
Primary Outcome Measures
NameTimeMethod
Efficacy of patients with LEVITRA treatmentAfter 6 months
Secondary Outcome Measures
NameTimeMethod
LEVITRA treatment improved the patient's erectionAfter 6 months
LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourseAfter 6 months
Reporting a second successful intercourse within 24 hours of dosingAfter 6 months
Tolerability of patients with LEVITRA treatmentAfter 6 months
Patients prefer LEVITRA over last Erectile Dysfunction treatmentAfter 6 months
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