LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Vardenafil (Levitra, BAY38-9456) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
Official title: LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers
Study design: Observational Model: Case-Only, Time Perspective: Prospective
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.unsatisfiedSafety of Levitra treatment, namely incidence of Adverse Events or Adverse Drug Reactions are evaluated
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.unsatisfied
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Patients >/= 18 years
- Enrollment within 7 days after initiation of combination use of Levitra and
alpha-blockers
Exclusion Criteria:
Locations and Contacts
Many Locations, Japan
Additional Information
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Starting date: October 2007
Last updated: January 19, 2015
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