check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

12842

ClinicalTrials.gov Identifier:

NCT00470873

EudraCT Number:

Not Available

EU CT Number:

Not Available
Vardenafil Treatment Of Erectile Dysfunction In Depressive And Non-Depressive Men

Trial purpose

The primary aim of this open, uncontrolled, prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. The secondary aim of this study is to assess the influence of the treatment with Levitra on self-esteem (depressive symptomology) in men with ED.

Key Participants Requirements

Sex

Male

Age

18 Years
  • - Age over 18
    - Erectile dysfunction untreated or ineffectively treated with other than vardenafil PDE5 inhibitors
  • - Treatment with nitrates
    - Allergy to vardenafil or other tablets ingredients
    - Treatment with CYP3A4 inhibitors (e.g. indinavir, ritonavir, ketoconazole, itraconazole, erythromycin)
    - Cardiovascular status excluding any sexual activity

Trial summary

Enrollment Goal
2471
Trial Dates
January 2007 - February 2008
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, Poland

Primary Outcome

  • Efficacy, safety, tolerance of the treatment with Vardenafil reported by the physician
    date_rangeTime Frame:
    At the patients control visit (approx. 3 months from the initial)
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    Safety Issue:
    Yes

Secondary Outcome

  • Influence of vardenafil on depressive symptoms and self-esteem measured with CES-D and Rosenberg scale
    date_rangeTime Frame:
    At the patients control visit (approx. 3 months from the initial)
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    Safety Issue:
    No

Trial design

A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Obtain Data on Safety and Efficacy of Levitra® in Routine Treatment of Erectile Dysfunction in Depressive and Non-Depressive Men.
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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