Tadalafil 2.5 or 5 mg Administered Once Daily for 12 Weeks in Men with Both Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia: Results of a Randomized, Placebo‐Controlled, Double‐Blind Study

Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH‐LUTS) commonly coexist in aging men. Tadalafil, a phosphodiesterase type 5 inhibitor approved for treating ED, is currently being evaluated for treating BPH‐LUTS. This multinational Phase 3 study assessed effects of tadalafil 2.5 or 5 mg once daily on ED and BPH‐LUTS in men with both conditions during 12 weeks of double‐blinded therapy. Men were ≥45 years old, sexually active, and experiencing ED for ≥3 months and BPH‐LUTS for >6 months. Randomization (baseline) followed a 4‐week placebo lead‐in; changes from baseline were assessed via analysis of covariance and compared to placebo. A gatekeeping procedure controlled for multiple comparisons of co‐primary and key secondary measures at end point (last post‐baseline observation). The co‐primary measures were the International Index of Erectile Function‐erectile function (IIEF‐EF) domain and International Prostate Symptom Score (IPSS) score; key secondary measures were the Sexual Encounter Profile Question 3 (SEP Q3) and BPH Impact Index (BII). Treatment‐emergent adverse events, serious adverse events, orthostatic vital signs, clinical laboratory and uroflowmetry parameters, and postvoid residual volume were assessed. Tadalafil 2.5 mg (N = 198) and 5 mg (N = 208) significantly improved IIEF‐EF domain scores (both P