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

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

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

Primary outcomes

Efficacy, safety, tolerance of the treatment with Vardenafil reported by the physician

Time frame: At the patients control visit (approx. 3 months from the initial)

Secondary outcomes

Influence of vardenafil on depressive symptoms and self-esteem measured with CES-D and Rosenberg scale

Time frame: At the patients control visit (approx. 3 months from the initial)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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.

Important dates

Study start: 2007
Study completion: 2008
First posted: May 8, 2007
Registry last updated: Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed