Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia

Bayer

Status and phase: Completed; Phase 2

Conditions: Benign Prostatic Hyperplasia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00657839

11863

EudraCT No. 2005-002796-32

Details and patient eligibility

About

Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily administration of 10 mg BID.

Enrollment: 222 patients

Sex: Male

Ages: 45 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males 45 to 64 years of age
• Lower urinary tract symptoms > 6 months
• International Prostate Symptom Score > 12

Exclusion criteria

• Prostate Specific Antigen > 3 ng/ml
• Residual urine volume > 150 m
• History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
• Nitrate use
• Other exclusion criteria apply acc. to Summary of Product Characteristics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

222 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