Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil

Bayer

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00661297

100536

Details and patient eligibility

About

Study to investigate the efficacy and safety of Vardenafil

Enrollment: 523 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heterosexual males
• >/= 18 years old with ED for more than six months
• Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation

Exclusion criteria

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
• Nitrate therapy
• Other exclusion criteria apply according to the Summary of Product Characteristics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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523 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo