check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
13930
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
LEVITRA® 20mg Special Drug Use Investigation (long-term)
Trial purpose
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.
Key Participants Requirements
Sex
MaleAge
18 - 64 YearsTrial summary
Enrollment Goal
1221Trial Dates
August 2007 - December 2011Phase
N/ACould I Receive a placebo
NoProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations, Japan |
Primary Outcome
- Efficacy of patients with LEVITRA treatmentdate_rangeTime Frame:After 6 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- LEVITRA treatment improved the patient's erectiondate_rangeTime Frame:After 6 monthsenhanced_encryptionNoSafety Issue:
- LEVITRA improved the patient's erection after
Minimum and Maximum Intervals between LEVITRA intake and the start of intercoursedate_rangeTime Frame:After 6 monthsenhanced_encryptionNoSafety Issue:
- Reporting a second successful intercourse within 24 hours of dosingdate_rangeTime Frame:After 6 monthsenhanced_encryptionNoSafety Issue:
- Patients prefer LEVITRA over last Erectile Dysfunction treatmentdate_rangeTime Frame:After 6 monthsenhanced_encryptionNoSafety Issue:
- Tolerability of patients with LEVITRA treatmentdate_rangeTime Frame:After 6 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/AAdditional Information
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