title: Efficacy and tolerability of lodenafil carbonate for oral therapy of erectile dysfunction: a phase III clinical trial.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  Expanding information on LC efficacy and safety.
  
  
  METHODS
  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 < 0.01). Positive answers to SEP-2 without and with the use of medication were the following (M +/- SD): placebo = 55.3 +/- 43.2% and 52.1 +/- 41.4%; LC 40 mg = 46.4 +/- 44.3% and 63.5 +/- 42.0%; LC 80 mg = 50.2 +/- 40.9% and 80.8 +/- 32.3% (ANOVA P < 0.01). Positive answers to SEP-3 were the following: placebo = 20.2 +/- 32.3% and 29.7 +/- 38.1%; LC 40 mg = 19.6 +/- 34.3% and 50.8 +/- 44.4%; LC 80 mg = 20.8 +/- 33.2% and 66.0 +/- 39.3% (ANOVA P < 0.01). The patients with at least one AE were placebo = 28.7%, LC 40 mg = 40.9%, and LC 80 mg = 49.5%. AEs whose incidence was significantly higher with LC than with placebo included rhinitis, headache, flushing, visual disorder, and dizziness.
  
  
  CONCLUSIONS
  LC showed a satisfactory efficacy-safety profile for oral therapy of ED.
authors.affiliation: Department of Urology, Hospital Ipiranga, São Paulo, SP, Brazil. glinas@terra.com.br
authors.forename: Sidney
authors.initials: S
authors.lastname: Glina
authors.forename: Gilvan N
authors.initials: GN
authors.lastname: Fonseca
authors.forename: Eduardo B
authors.initials: EB
authors.lastname: Bertero
authors.forename: Ronaldo
authors.initials: R
authors.lastname: Damião
authors.forename: Luíz C A
authors.initials: LC
authors.lastname: Rocha
authors.forename: Carlos R F
authors.initials: CR
authors.lastname: Jardim
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Cairoli
authors.forename: Cláudio
authors.initials: C
authors.lastname: Teloken
authors.forename: Luiz O
authors.initials: LO
authors.lastname: Torres
authors.forename: Geraldo E
authors.initials: GE
authors.lastname: Faria
authors.forename: Marcelo B
authors.initials: MB
authors.lastname: da Silva
authors.forename: Eduardo
authors.initials: E
authors.lastname: Pagani
mesh_terms: D000368:Aged; D002254:Carbonates / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection / Q000187:drug effects; D058986:Phosphodiesterase 5 Inhibitors; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D002254:Carbonates; D058986:Phosphodiesterase 5 Inhibitors; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011743:Pyrimidines; C532120:lodenafil carbonate