ORIGINAL RESEARCH—ED PHARMACOTHERAPY: Efficacy and Tolerability of Lodenafil Carbonate for Oral Therapy of Erectile Dysfunction: A Phase III Clinical Trial
التفاصيل البيبلوغرافية
العنوان:
ORIGINAL RESEARCH—ED PHARMACOTHERAPY: Efficacy and Tolerability of Lodenafil Carbonate for Oral Therapy of Erectile Dysfunction: A Phase III Clinical Trial
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). Methods A total of 350 men with erectile dysfunction (ED) of all degrees were randomized to placebo, LC 40 mg or LC 80 mg and followed for 4 weeks. They completed the IIEF and answered the SEP questions 2 and 3 after each intercourse without and with the use of LC. Results IIEF Erectile Domain scores without and with the use of medication were the following (mean [M] ± standard deviation [SD]): placebo = 13.9 ± 5.2 and 14.8 ± 7.8; LC 40 mg = 13.6 ± 5.3 and 18.6 ± 8.0; LC 80 mg = 13.4 ± 4.9 and 20.6 ± 7.7 (analysis of variance [ anova ] P anova P anova P Conclusions LC showed a satisfactory efficacy–safety profile for oral therapy of ED. Glina S, Fonseca GN, Bertero EB, Damiao R, Rocha LCA, Jardim CRF, Cairoli CE, Teloken C, Torres LO, Faria GE, da Silva MB, and Pagani E. Efficacy and tolerability of lodenafil carbonate for oral therapy of erectile dysfunction: A phase III clinical trial.
