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

NCT ID: NCT00663130

Last Updated: 2013-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 759 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2004-07-31

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

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Levitra (Vardenafil, BAY38-9456)

Intervention Type: DRUG

Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse

Arm 2

Group Type: ACTIVE_COMPARATOR

Tadalafil

Intervention Type: DRUG

Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse

Interventions

Levitra (Vardenafil, BAY38-9456)

Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse

Intervention Type: DRUG

Tadalafil

Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Other Identifiers

11333

Identifier Type: -

Identifier Source: org_study_id