stop_circleTerminated/Withdrawn
Erectile Dysfunction
Bayer Identifier:
14328
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Real life safety and efficacy of vardenafil
Trial purpose
In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. The general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
372Trial Dates
February 2008 - November 2008Phase
N/ACould I Receive a placebo
NoProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Many Locations, Taiwan |
Primary Outcome
- General assessment of patients concerning efficacy and tolerability of vardenafil treatmentdate_rangeTime Frame:2 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Time to first intercourse after intake of vardenafildate_rangeTime Frame:2 monthsenhanced_encryptionNoSafety Issue:
- Percentage of successful second intercourse within 24 hoursdate_rangeTime Frame:2 monthsenhanced_encryptionNoSafety Issue:
- Percentage of participants who are willing to continue treatmentdate_rangeTime Frame:2 monthsenhanced_encryptionNoSafety Issue:
- Number of participants with adverse eventsdate_rangeTime Frame:2 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A