Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Bayer

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662441

100578

Details and patient eligibility

About

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).

Enrollment: 102 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men >/= 18 years of age
• Erectile Dysfunction

Exclusion criteria

• 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: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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102 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Levitra (Vardenafil, BAY38-9456)