Real Life Safety and Efficacy of Vardenafil

Bayer

Status: Terminated

Conditions: Erectile Dysfunction

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01215409

14328

LV0611TW (Other Identifier)

Details and patient eligibility

About

In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. The general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.

Enrollment: 372 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any adult patient (>/=18 years) with erectile dysfunction treated with LEVITRA®.
• Patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study.

Exclusion criteria

• Exclusion criteria must be read in conjunction with the product information (Package Insert).

Trial design

372 participants in 1 patient group

Group 1

Treatment:

Drug: Vardenafil (Levitra, BAY38-9456)