A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms

A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia

The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.

Inclusion Criteria:

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

  • All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
  • Overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
  • Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
  • Finasteride or dutasteride use at any time.

• Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before receiving study drug.

• Have prostate enlargement measured by ultrasound at screening.

Exclusion Criteria:

• Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer [Prostate-specific antigen (PSA) greater than 10 nanograms/milliliter (ng/mL) at the start of study].
• 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 had a stroke or a significant injury to brain or spinal cord.
• Have scheduled or planned surgery during the course of the study.