LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers
- Registration Number
- NCT01207947
- Lead Sponsor
- Bayer
- Brief Summary
Main object is to investigate the safety profile of Levitra in combination use with alpha-blockers in patients with erectile dysfunction used in clinical practice after launch.
In the initial combination date and the first and second observation after initial combination date, number of tablets prescribed, dose of tablets and number of tablets taken until follow-up visit will be investigated. The efficacy and tolerability will be evaluated at 2 months after initial combination date.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 491
Inclusion Criteria
- Patients >/= 18 years
- Enrollment within 7 days after initiation of combination use of Levitra and alpha-blockers
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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 Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied 2 months Safety of Levitra treatment, namely incidence of Adverse Events or Adverse Drug Reactions are evaluated 2 months
- Secondary Outcome Measures
Name Time Method Tolerability of patients with Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied 2 months