A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia

Inclusion Criteria:

• Have BPH Lower Urinary Tract Symptoms (LUTS) based on the disease diagnostic criteriaat 1st screening.

• Have a history of ED based on the disease diagnostic criteria at 1st screening.

• Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than orequal to 13 at 2nd screening.

• Have bladder outlet obstruction as defined by a Peak Urine Flow Rate (Qmax) of greaterthan or equal to 4 to less than or equal to 15 milliliter (mL)/second (sec) (from aprevoid total bladder volume as assessed by ultrasound of greater than or equal to 150to less than or equal to 550 mL and a minimum voided volume of 125 mL) at 2ndscreening.

• Make at least 4 sexual intercourse attempts during the 4-weeks after 2nd screening asrecorded in the Sexual Encounter Profile (SEP) diary.

• Are sexually active with an adult female partner, and expect to remain sexually activewith the same adult female partner for the duration of the study.

• Agree not to use any other approved or experimental BPH, overactive bladder (OAB), orED 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.

• Prostate-specific antigen (PSA) greater than 10.0 nanogram (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 screeningif prostate malignancy has not been ruled out to the satisfaction of a urologist.

• Clinical evidence of prostate cancer.

• Bladder postvoid residual volume (PVR) greater than or equal to 300 mL by ultrasounddetermination at 1st screening.

• History or clinical evidence of certain pelvic, bladder, urinary tract, or urinaryretention conditions described in the protocol.

• Lower urinary tract instrumentation (including prostate biopsy) within 30 days of 1stscreening.

• Clinical evidence of severe hepatic impairment at 1st screening.

• Current neurologic disease or condition associated with neurogenic bladder (forexample, 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 ejaculationor 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 epiduralanesthesia) during the course of the study.

• History of significant central nervous system injuries (including stroke or spinalcord injury) within 6 months of 1st screening.

• Glycosylated hemoglobin (HbA1c) greater than 9% at 1st screening.

• Prior treatment with phosphodiesterase type 5 (PDE5) inhibitors judged by theinvestigator to be ineffective. However, if the investigator judges that a subject'slack of response to as-needed PDE5 inhibitors is the result of inadequate coordinationbetween dosing and sexual activity with a treatment, the subject may be enrolled.