Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)

Phase 4

Completed

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

• Registration Number: NCT00663130
• Lead Sponsor: Bayer

Brief Summary

Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-22
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-09
• Last Update Posted: 2013-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 759

Inclusion Criteria

• Age between 18 and 64 years
• Heterosexual males
• Erectile dysfunction for more than 6 months

Exclusion Criteria

• Penile anatomical abnormalities
• Spinal cord injury
• History of surgical prostatectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Levitra (Vardenafil, BAY38-9456)	-
Arm 2	Tadalafil	-

Primary Outcome Measures

Name	Time	Method
Sexual Encounter Profile Question 3 (SEP-3)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Sexual Encounter Profile Question 2 (SEP-2)	4 weeks
Global Confidence Question (GCQ)	4 weeks
General Safety	4 weeks
International Index of Erectile Function	4 weeks
Erection Quality Scale (EQS)	4 weeks