A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers

• Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit [ Time Frame: Baseline through 12 Weeks ] [ Designated as safety issue: Yes ]
  A positive orthostatic test is defined as at least one of the following 4 criteria being met at any pre-randomization or post-randomization visit: (1) reduction in systolic blood pressure of >= 20 mmHg from the supine to standing position;(2)reduction in diastolic blood pressure of >=10 mmHg from the supine to standing position;(3)increase in heart rate of >= 20 bpm from the supine to standing position; or (4)Unable to remain standing. A negative orthostatic test is defined as none of the above 4 criteria (1, 2, 3, or 4) being met at any pre-randomization or post-randomization visit.
• International Prostate Symptom Score (IPSS) Change From Baseline [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  Change from baseline to endpoint in IPSS Score. The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
• Postvoid Residual Volume (PVR) Change From Baseline [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: Yes ]
  Change from baseline to endpoint in PVR volume. PVR is obtained by measuring with ultrasound the remaining urine in the bladder after urination.
• Uroflowmetry (Qmax) Change From Baseline [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: Yes ]
  Change from baseline to endpoint in Qmax. Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).

• Orthostatic vital signs [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: Yes ]
• International Prostate Symptom Score (IPSS) [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]
• Postvoid residual volume (PVR) [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: Yes ]
• Uroflowmetry (Qmax) [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: Yes ]

The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied after urination).

• Drug: Tadalafil
  5 mg taken by mouth once daily for 12 weeks
  Other Names:

  • LY450190
  • Cialis
• Drug: Placebo
  By mouth once daily for 12 weeks

• Placebo Comparator: Placebo
  Intervention: Drug: Placebo
• Experimental: Tadalafil
  Intervention: Drug: Tadalafil

Inclusion Criteria:

• Stable on alpha blocker therapy for the treatment of BPH for at least 4 weeks prior to starting the study.

• Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:

  1. All other Benign Prostatic Hyperplasia therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
  2. Overactive Bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
  3. Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
• If taking finasteride or dutasteride, must have been taking treatment for at least 6 months.

Exclusion Criteria:

• Currently receiving alpha-blocker therapy for the treatment of hypertension.
• History of symptoms associated with orthostasis, including recurrent episodes of dizziness, lightheadedness, loss of consciousness, or syncope.
• Treated with nitrates for any cardiac conditions.
• Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
• Have problems with kidneys, liver, or nervous system
• Have uncontrolled diabetes
• Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (PSA greater than 10 ng/ml at the start of study).
• Have had a stroke or a significant injury to brain or spinal cord.