Clinics (Sao Paulo)
October 2011
Introduction: This is a phase III, prospective, randomized, double-blind, placebo-controlled clinical trial on lodenafil carbonate (LC), a novel phosphodiesterase 5 inhibitor developed in Brazil.
Aim: Expanding information on LC efficacy and safety.
Main Outcome Measures: International Index of Erectile Function (IIEF) erectile domain, positive answers to the sexual encounter profile (SEP)-2 and SEP-3 questions and incidence of adverse events (AEs).
Objective: Establish the efficiency of 6- and 12-punctures transrectal ultrasound-guided needle biopsies in low risk patients for prostate cancer. Six-punctures (sextant) biopsies were compared to 12-punctures biopsies, assessing which is the best strategy to detect this neoplasm.
Materials And Methods: Among 240 patients submitted to prostate biopsy, 54 with suspected small and organ-localized tumors (prostatic specific antigen = 10 ng/mL and digital exam of the prostate not suggesting cancer) in glands < 50 cm3 were selected, constituting a homogenous sample.