Therapeutic Effectiveness of Vardenafil in Patients With Erectile Dysfunction and Metabolic Syndrome in Daily Clinical Practice (REVITALISE)

Bayer

Status: Completed

Conditions: Erectile Dysfunction

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01106118

LV0901 (Other Identifier)

14872

Details and patient eligibility

About

The primary goal of this international non-interventional study is to investigate the therapeutic effectiveness of vardenafil (film-coated tablet) in Erectile Dysfunction patients with the Metabolic Syndrome in daily clinical practice. It will include a large number of patients with various underlying conditions with different cultural and demographic backgrounds from different geographic areas.

Enrollment: 2,289 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Erectile Dysfunction (ED) patient who has newly been prescribed vardenafil (Levitra film-coated tablet) in accordance with the terms of the local marketing authorization.
• Diagnosis of erectile dysfunction at the discretion of the physician, based on the patients ED history.
• No use of any Phosphodiesterase Type 5 (PDE5) inhibitor within 1 month of study entry.
• Documented Metabolic Syndrome (MetS), preferably according to the definition of the International Diabetes Foundation.

Exclusion criteria

• Do not follow the contraindications and warnings of the Summary of Product Characteristics.

Trial design

2,289 participants in 1 patient group

Group 1

Treatment:

Drug: Vardenafil (Levitra, BAY38-9456)