REPEAT - Real-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra Therapy
- Registration Number
- NCT00874679
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 7293
- Outpatients with diagnosis of erectile dysfunction, decision taken by the investigator to prescribe Vardenafil.
- Exclusion criteria must be read in conjunction with the local product information. All contraindications listed in the local product information are applicable.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Levitra (Vardenafil, BAY38-9456) -
- Primary Outcome Measures
Name Time Method Physician's assessment of safety (incidence of adverse events) During observation period
- Secondary Outcome Measures
Name Time Method 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 Severity of ED symptoms End of study