Real Life Safety and Efficacy of Vardenafil

Terminated

• Conditions: Erectile Dysfunction
• Interventions: Drug: Vardenafil (Levitra, BAY38-9456)

• Registration Number: NCT01215409
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-16
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 372

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Vardenafil (Levitra, BAY38-9456)	-

Primary Outcome Measures

Name	Time	Method
General assessment of patients concerning efficacy and tolerability of vardenafil treatment	2 months

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	2 months
Percentage of participants who are willing to continue treatment	2 months
Time to first intercourse after intake of vardenafil	2 months
Percentage of successful second intercourse within 24 hours	2 months