LEVITRA® 20mg Special Drug Use Investigation (Long-term)
2 other identifiers
observational
1,221
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 8, 2009
CompletedFirst Posted
Study publicly available on registry
May 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 15, 2014
December 1, 2014
2.6 years
May 8, 2009
December 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of patients with LEVITRA treatment
After 6 months
Secondary Outcomes (5)
LEVITRA treatment improved the patient's erection
After 6 months
LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse
After 6 months
Reporting a second successful intercourse within 24 hours of dosing
After 6 months
Patients prefer LEVITRA over last Erectile Dysfunction treatment
After 6 months
Tolerability of patients with LEVITRA treatment
After 6 months
Study Arms (1)
Group 1
Interventions
Patients under daily life treatment receiving Levitra according to local drug information.
Eligibility Criteria
Primary care clinic
You may qualify if:
- 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.
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
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 8, 2009
First Posted
May 27, 2009
Study Start
August 1, 2007
Primary Completion
March 1, 2010
Study Completion
December 1, 2011
Last Updated
December 15, 2014
Record last verified: 2014-12