Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Bayer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Erectile Dysfunction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00656188

10898 (Registry Identifier)

GSK 001

Details and patient eligibility

About

This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

Enrollment: 463 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
• History of unresponsiveness to sildenafil
• Stable sexual relationship for > 6 month

Exclusion criteria

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
• Nitrate therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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463 participants in 2 patient groups, including a placebo group

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo

Arm 1

Active Comparator group

Treatment:

Drug: Levitra (Vardenafil, BAY38-9456)