check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

13931

ClinicalTrials.gov Identifier:

NCT01207947

EudraCT Number:

Not Available

EU CT Number:

Not Available
LEVITRA® Specific Drug Use Investigation. To investigate the safety profile in combination use with alpha-blockers

Trial purpose

Main object is to investigate the safety profile of Levitra in combination use with alpha-blockers in patients with erectile dysfunction used in clinical practice after launch.
In the initial combination date and the first and second observation after initial combination date, number of tablets prescribed, dose of tablets and number of tablets taken until follow-up visit will be investigated. The efficacy and tolerability will be evaluated at 2 months after initial combination date.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - Patients >/= 18 years
    - Enrollment within 7 days after initiation of combination use of Levitra and alpha-blockers

Trial summary

Enrollment Goal
491
Trial Dates
October 2007 - March 2010
Phase
Phase 4
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Efficacy of Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied
    date_rangeTime Frame:
    2 months
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    Safety Issue:
    No
  • Safety of Levitra treatment, namely incidence of Adverse Events or Adverse Drug Reactions are evaluated
    date_rangeTime Frame:
    2 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Tolerability of patients with Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied
    date_rangeTime Frame:
    2 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

LEVITRA® Specific Drug Use Investigation. To investigate the safety profile in combination use with alpha-blockers
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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