stop_circleTerminated/Withdrawn

Erectile Dysfunction

Bayer Identifier:

14328

ClinicalTrials.gov Identifier:

NCT01215409

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

Male

Age

18 - N/A
  • - 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 must be read in conjunction with the product information (Package Insert).

Trial summary

Enrollment Goal
372
Trial Dates
February 2008 - November 2008
Phase
N/A
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Many Locations, Taiwan

Primary Outcome

  • General assessment of patients concerning efficacy and tolerability of vardenafil treatment
    date_rangeTime Frame:
    2 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Time to first intercourse after intake of vardenafil
    date_rangeTime Frame:
    2 months
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of successful second intercourse within 24 hours
    date_rangeTime Frame:
    2 months
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants who are willing to continue treatment
    date_rangeTime Frame:
    2 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    2 months
    enhanced_encryption
    Safety Issue:
    Yes

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
N/A

Additional Information

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