Trial Condition(s):
Erectile Dysfunction
Vardenafil Treatment Of Erectile Dysfunction In Depressive And Non-Depressive Men
Bayer Identifier:
12842
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Age over 18 - Erectile dysfunction untreated or ineffectively treated with other than vardenafil PDE5 inhibitors
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, Poland | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Efficacy, safety, tolerance of the treatment with Vardenafil reported by the physicianTimeframe: At the patients control visit (approx. 3 months from the initial)
Secondary Outcome
- Influence of vardenafil on depressive symptoms and self-esteem measured with CES-D and Rosenberg scaleTimeframe: At the patients control visit (approx. 3 months from the initial)
Additional Information
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