Trial Condition(s):
Erectile Dysfunction
LEVITRA® Specific Drug Use Investigation. To investigate the safety profile in combination use with alpha-blockers
Bayer Identifier:
13931
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
Inclusion Criteria: - Patients >/= 18 years - Enrollment within 7 days after initiation of combination use of Levitra and alpha-blockers
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
LEVITRA® Specific Drug Use Investigation. To investigate the safety profile in combination use with alpha-blockers
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- 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.unsatisfiedTimeframe: 2 months
- Safety of Levitra treatment, namely incidence of Adverse Events or Adverse Drug Reactions are evaluatedTimeframe: 2 months
Secondary Outcome
- 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.unsatisfiedTimeframe: 2 months
Additional Information
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