Vardenafil Treatment Of Erectile Dysfunction In Depressive And Non-Depressive Men

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00470873

Enrollment

2471

Registered

2007-05-08

Start date

2007-01-31

Completion date

2008-02-29

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Brief summary

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.

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

Primary care erectile dysfunction patients for whom physician decided to start the treatment with vardenafil

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Efficacy, safety, tolerance of the treatment with Vardenafil reported by the physician	At the patients control visit (approx. 3 months from the initial)

Secondary

Measure	Time frame
Influence of vardenafil on depressive symptoms and self-esteem measured with CES-D and Rosenberg scale	At the patients control visit (approx. 3 months from the initial)

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026