Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Pilot Study to Evaluate the Efficacy and Safety of Tadalafil and Tamsulosin Once-a-Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia

The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment.

Inclusion Criteria:

• Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at least 6 months prior to Visit 1.
• Agree not to use any other approved or experimental treatments for erectile dysfunction or BPH-LUTS during the study.
• Have not taken Finasteride therapy for at least 3 months prior to Visit 2.
• Have not taken Dutasteride therapy for at least 6 months prior to Visit 2.
• Have an International Prostate Symptom Score (IPSS) total score greater than or equal to 13 at Visit 2.

Exclusion Criteria:

• Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (ng/mL) at Visit 1.
• Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at Visit 1.
• History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower urinary tract malignancy or trauma.
• Urinary tract infection or inflammation or current antibiotic therapy for urinary tract infection at Visit 1.
• Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.