Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

• Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Presence of Involuntary Detrusor Contractions During Bladder Filling [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]

The purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil.

• Drug: Tadalafil
  20 mg tadalafil tablet taken by mouth once a day for 12 weeks.
  Other Names:

  • LY450190
  • Cialis
  • IC351
• Drug: Placebo
  Placebo tablet taken by mouth once a day for 12 weeks.

• Placebo Comparator: 1
  Placebo
  Intervention: Drug: Placebo
• Active Comparator: 2
  tadalafil
  Intervention: Drug: Tadalafil

Inclusion Criteria:

• Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1.
• Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
• Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2.
• Have had BPH-LUTS for greater than 6 months prior to Visit 1.

Exclusion Criteria:

• Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
• History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
• Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis).
• History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
• History of angina requiring treatment with nitrates.
• Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.