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

Bayer

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Drug: Levitra (Vardenafil, BAY38-9456)

Study type: Observational

Funder types: Industry

Identifiers

NCT00470873

VALOR

LV0610PL

12842

Details and patient eligibility

About

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.

Enrollment: 2,471 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

2,471 participants in 1 patient group

Group 1

Treatment:

Drug: Levitra (Vardenafil, BAY38-9456)