Erectile Dysfunction
Conditions
Brief summary
The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. Furthermore, the data collection particularly focuses on the experience of the patient and his satisfaction with the treatment. Treatment naive patients as well as pre-treated patients will be included in the study.The maximum observation period per patient is 12 months.Besides the physician's documentation, the patient should fill out a questionnaire at every visit. The questionnaires will be handed out and collected by the physician. Furthermore, an additional questionnaire for the patient's partner can be distributed at each visit in case the partner is willing to participate.
Interventions
DRUGLevitra (Vardenafil, BAY38-9456)
Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatients with diagnosis of erectile dysfunction, decision taken by the investigator to prescribe Vardenafil.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physician's assessment of safety (incidence of adverse events) | During observation period |
Secondary
| Measure | Time frame |
|---|---|
| Severity of ED symptoms | End of study |
| General quality of partnership as assessed by patient | Initial visit and after 3, 6, 9 and 12 months |
| General quality of partnership as assessed by partner | Initial visit and after 3, 6, 9 and 12 months |
Countries
China, Croatia, France, Germany, Hungary, Indonesia, Malaysia, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Thailand
Outcome results
None listed