Trial Condition(s):
Erectile Dysfunction
Real life safety and efficacy of vardenafil
Bayer Identifier:
14328
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Terminated/Withdrawn
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.
Inclusion Criteria
- Any adult patient (>/=18 years) with erectile dysfunction treated with LEVITRA®. - Patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study.
Exclusion Criteria
- Exclusion criteria must be read in conjunction with the product information (Package Insert).
Trial Summary
Enrollment Goal
372
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Taiwan, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Vardenafil in routine treatment of Erectile Dysfunction
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- General assessment of patients concerning efficacy and tolerability of vardenafil treatmentTimeframe: 2 months
Secondary Outcome
- Time to first intercourse after intake of vardenafilTimeframe: 2 months
- Percentage of successful second intercourse within 24 hoursTimeframe: 2 months
- Percentage of participants who are willing to continue treatmentTimeframe: 2 months
- Number of participants with adverse eventsTimeframe: 2 months
Additional Information
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