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

Bayer

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00663130

11333 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 759 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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759 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

Active Comparator group

Treatment:

Drug: Tadalafil