A Randomized, Double‐Blind, Placebo‐Controlled, Parallel Study to Assess the Efficacy and Safety of Once‐A‐Day Tadalafil in Men with Erectile Dysfunction Who Are Naïve to PDE5 Inhibitors

摘要: ABSTRACT Introduction The majority of subjects included in previous tadalafil once‐a‐day clinical trials were non‐naive to phosphodiesterase 5 (PDE5) inhibitors on demand. A study PDE5 inhibitor naive was therefore warranted. Aim To evaluate the efficacy and safety inhibitor‐naive men with erectile dysfunction (ED). Main Outcomes Measures Primary end points changes from baseline point International Index Erectile Function (IIEF) (EF) domain score per‐subject proportion “yes” responses sexual encounter profile (SEP) question 2 (SEP2) 3 (SEP3). Methods ED (N = 217) randomized a 1:2 ratio receive placebo or 5 mg once day for 12 weeks. Enrollment began January 2009 last subject completed 2010. Results At point, least square mean change IIEF‐EF (7.3 vs. 3.4), SEP2 (23.8% 12.2%) SEP3 (39.5% 21.5%), significantly larger (all P Conclusions In men, improved EF compared placebo. Safety results consistent trials. Montorsi F, Aversa A, Moncada I, Perimenis P, Porst H, Barker C, Shane MA, Sorsaburu S. randomized, double‐blind, placebo‐controlled, parallel assess who are inhibitors. J Sex Med 2011;8:2617–2624.