title: Onset of efficacy of tadalafil once daily in men with erectile dysfunction: a randomized, double-blind, placebo controlled trial.
abstract: OBJECTIVE
  We evaluated the efficacy onset and safety of tadalafil 2.5 and 5 mg once daily for 14 days compared with placebo in men with erectile dysfunction.
  
  
  METHODS
  In this randomized, double-blind, placebo controlled, parallel group study we randomized 372 men after a 4-week run-in period to receive placebo, or tadalafil 2.5 or 5 mg once daily for 14 days, followed by a 14-day open label extension period of tadalafil 5 mg once daily. Primary analysis focused on the cumulative percent of men with a successful intercourse attempt during the first 4 days of treatment. On secondary analysis we evaluated the percent of successful attempts during the study. The Sexual Encounter Profile diary question 3 was used to assess efficacy. Safety was assessed by monitoring adverse events and vital signs.
  
  
  RESULTS
  Significantly more men in the tadalafil 5 mg group achieved successful intercourse, as indicated by a yes response to diary question 3, than those on placebo by day 2 (48.6% vs 36.6%, p < 0.025). The tadalafil 2.5 mg group did not separate from the placebo group on primary analysis. Secondary analysis showed that men on tadalafil 2.5 mg achieved a significantly higher percent of successful intercourse attempts than those on placebo by day 3 (35.5% vs 27.2%, p < 0.025). All groups further improved during the open label extension period. Tadalafil was well tolerated.
  
  
  CONCLUSIONS
  This prospective trial shows the onset of efficacy of tadalafil 2.5 and 5 mg once daily within a few days of initiating therapy.
authors.affiliation: Division of Urology, Cooper University Medical Center, Camden, New Jersey 08103, USA. allendseftel@gmail.com
authors.forename: Allen
authors.initials: A
authors.lastname: Seftel
authors.forename: Evan
authors.initials: E
authors.lastname: Goldfischer
authors.forename: Edward D
authors.initials: ED
authors.lastname: Kim
authors.forename: Eugene
authors.initials: E
authors.lastname: Dula
authors.forename: Haoyue
authors.initials: H
authors.lastname: Zeigler
authors.forename: Patrick
authors.initials: P
authors.lastname: Burns
mesh_terms: D002243:Carbolines / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage*; D011446:Prospective Studies; D000068581:Tadalafil
chemical_list: D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil