LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers
2 other identifiers
observational
491
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 20, 2010
CompletedFirst Posted
Study publicly available on registry
September 23, 2010
CompletedJanuary 21, 2015
January 1, 2015
1.7 years
September 20, 2010
January 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
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
Study Arms (1)
Group 1
Interventions
Patients under daily life treatment receiving Levitra according to local drug information.
Eligibility Criteria
Erectile dysfunction patients of 18 years-old or older and also the patients with combination use of alpha-blockers.
You may qualify if:
- Patients \>/= 18 years
- Enrollment within 7 days after initiation of combination use of Levitra and alpha-blockers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Many Locations, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2010
First Posted
September 23, 2010
Study Start
October 1, 2007
Primary Completion
June 1, 2009
Study Completion
March 1, 2010
Last Updated
January 21, 2015
Record last verified: 2015-01