check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:
12805
ClinicalTrials.gov Identifier:
NCT00874679
EudraCT Number:
Not Available
EU CT Number:
Not Available
REPEAT - Real-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra Therapy

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A

  • - 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.

Trial summary

Enrollment Goal
7293
Trial Dates
March 2007 - April 2010
Phase
N/A
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, France
Completed
Many Locations, Hungary
Completed
Many Locations, Malaysia
Completed
Many Locations, Saudi Arabia
Completed
Many Locations, Singapore
Completed
Many Locations, Thailand
Completed
Many Locations, South Africa
Completed
Many Locations, South Korea
Completed
Many Locations, Germany
Completed
Many Locations, China
Completed
Many Locations, Spain
Completed
Many Locations, Croatia
Completed
Many Locations, Indonesia
Completed
Many Locations, Poland
Completed
Many Locations, Sweden

Primary Outcome

  • Physician's assessment of safety (incidence of adverse events)
    date_rangeTime Frame:
    During observation period
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Severity of ED symptoms
    date_rangeTime Frame:
    End of study
    enhanced_encryption
    Safety Issue:
    No
  • General quality of partnership as assessed by patient
    date_rangeTime Frame:
    Initial visit and after 3, 6, 9 and 12 months
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    Safety Issue:
    No
  • General quality of partnership as assessed by partner
    date_rangeTime Frame:
    Initial visit and after 3, 6, 9 and 12 months
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    Safety Issue:
    No

Trial design

REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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