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

<jats:title>ABSTRACT</jats:title> <jats:sec> <jats:title>Introduction</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Aims</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>Men were ≥45 years old, sexually active, and experiencing ED for ≥3 months and BPH-LUTS for &gt;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).</jats:p> </jats:sec> <jats:sec> <jats:title>Main Outcome Measures</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>Tadalafil 2.5 mg (N = 198) and 5 mg (N = 208) significantly improved IIEF-EF domain scores (both P &lt; 0.001) vs. placebo (N = 200) at end point. For IPSS, improvements were significant with tadalafil 5 mg (P &lt; 0.001), but not 2.5 mg, for observations from 2 weeks through end point (least-squares mean ± standard error change from baseline at end point, placebo −3.8 ± 0.5, tadalafil 2.5 mg −4.6 ± 0.4, and 5 mg −6.1 ± 0.4). Tadalafil 5 mg significantly improved SEP Q3 and BII (P &lt; 0.001). Overall, tadalafil was well tolerated with no clinically adverse changes in orthostatic vital signs or uroflowmetry parameters.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>Tadalafil 5 mg significantly improved both ED and BPH-related outcomes through 12 weeks and was well tolerated.</jats:p> </jats:sec>