Tadalafil Administered Once Daily for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Dose Finding Study

Study design with schedule of events

Patient Consolidated Standards of Reporting Trials diagram. Asterisk indicates that 1 patient randomized at 2 sites was excluded from study and another two who were randomized did not receive study drug.

Mean change from baseline to end point after 4, 8 and 12 weeks. A, I-PSS. At weeks 4, 8 and 12 vs placebo 2.5 mg tadalafil (Tad) ANCOVA p = 0.001, 0.028 and 0.007, respectively, and 5, 10 and 20 mg ANCOVA p <0.001. B, for tadalafil 2.5 mg no significance vs placebo. Vs placebo 5 and 10 mg tadalafil at week 8 ANCOVA p <0.001, and at weeks 4 and 12 ANCOVA p <0.05. Vs placebo at weeks 4 and 8, 20 mg tadalafil ANCOVA p <0.001 and at week 12 ANCOVA p <0.05.