Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.

• Erectile Dysfunction
• Benign Prostatic Hyperplasia

• Drug: Tadalafil
  tablet once daily by mouth for 12 weeks.
  Other Names:

  • Cialis
  • LY450190
• Drug: Placebo
  Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.

• Tadalafil 2.5 mg: Experimental
  Intervention: Drug: Tadalafil
• Tadalafil 5 mg: Experimental
  Intervention: Drug: Tadalafil
• Placebo: Placebo Comparator
  Intervention: Drug: Placebo

Inclusion Criteria:

• Have BPH LUTS based on the disease diagnostic criteria at 1st screening.
• Have a history of ED based on the disease diagnostic criteria at 1st screening.
• Have Lower Urinary Tract Symptoms (LUTS) with a Total IPSS greater than or equal to 13 at 2nd screening.
• Have bladder outlet obstruction as defined by a Qmax of greater than or equal to 4 to less than or equal to 15 mL/second (from a prevoid total bladder volume as assessed by ultrasound of greater than or equal to 150 to less than or equal to 550 mL and a minimum voided volume of 125 mL) at 2nd screening.
• Make at least 4 sexual intercourse attempts during the 4-weeks after 2nd screening as recorded in the SEP diary.
• Are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study.
• Agree not to use any other approved or experimental BPH, OAB, or ED treatments as indicated in the protocol at any time during the study.
• Have not taken treatments indicated in the protocol prior to the 2nd screening.

Exclusion Criteria:

• Current treatment with nitrates.
• PSA greater than 10.0 ng/mL at 1st screening.
• PSA greater than or equal to 4.0 to less than or equal to 10.0 ng/mL at 1st screening if prostate malignancy has not been ruled out to the satisfaction of a urologist.
• Clinical evidence of prostate cancer.
• Bladder PVR greater than or equal to 300 mL by ultrasound determination at 1st screening.
• History or clinical evidence of certain pelvic, bladder, urinary tract, or urinary retention conditions described in the protocol.
• Lower urinary tract instrumentation (including prostate biopsy) within 30 days of 1st screening.
• Clinical evidence of severe hepatic impairment at 1st screening.
• Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease or multiple sclerosis).
• History of significant renal insufficiency as defined by the protocol.
• History of ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease.
• Presence of penile deformity judged by the investigator to be clinically significant.
• History of certain cardiac or cardiovascular conditions described in the protocol.
• History of resuscitated cardiac arrest.
• Current treatment with certain medications described in the protocol.
• Scheduled or planned surgery (or any procedure requiring general, spinal, or epidural anesthesia) during the course of the study.
• History of significant central nervous system injuries (including stroke or spinal cord injury) within 6 months of 1st screening.
• HbA1c greater than 9% at 1st screening.
• Prior treatment with PDE5 inhibitors judged by the investigator to be ineffective. However, if the investigator judges that a subject's lack of response to as-needed PDE5 inhibitors is the result of inadequate coordination between dosing and sexual activity with a treatment, the subject may be enrolled.