title: Efficacy of Avanafil 15 Minutes after Dosing in Men with Erectile Dysfunction: A Randomized, Double-Blind, Placebo Controlled Study.
abstract: OBJECTIVE
  We examined the therapeutic effects of avanafil 15 minutes after dosing in men with mild to severe erectile dysfunction.
  
  
  METHODS
  This randomized, double-blind, placebo controlled, 12-week study (4-week run-in and 8-week treatment) randomized 145 men to placebo, 147 to avanafil 100 mg and 148 to avanafil 200 mg on demand. The primary efficacy variable was the per subject proportion of sexual attempts during the treatment period in which subjects achieved erection sufficient for vaginal penetration within approximately 15 minutes after dosing as measured by a stopwatch. The attempt had to enable successful completion of sexual intercourse according to SEP question 3.
  
  
  RESULTS
  Significantly greater mean per subject percentages of successful intercourse attempts within approximately 15 minutes after dosing were observed for avanafil 100 mg (mean 25.9%, LS mean ± SE 24.7% ± 2.9%) and 200 mg (mean 29.1%, LS mean 28.2% ± 2.9%) vs placebo (mean 14.9%, LS mean 13.8% ± 2.9%, p = 0.001 and <0.001, respectively). After treatment we noted a statistically significant difference between avanafil and placebo in the average per subject proportion of successful intercourse attempts according to SEP question 3 as early as 10 minutes in the 200 mg group and 12 minutes in the 100 mg group. Treatment emergent adverse events included headache, upper respiratory tract infection and nasal congestion, and most such events were mild or moderate in severity.
  
  
  CONCLUSIONS
  Avanafil was efficacious within approximately 15 minutes of dosing compared to placebo. A statistically significant treatment difference in the percentage of successful sexual attempts was demonstrated as early as 10 minutes after treatment.
authors.affiliation: Tulane University School of Medicine, New Orleans, Louisiana. Electronic address: whellst@tulane.edu.
authors.forename: Wayne J G
authors.initials: WJ
authors.lastname: Hellstrom
authors.affiliation: University Urology Associates, New York, New York.
authors.forename: Jed
authors.initials: J
authors.lastname: Kaminetsky
authors.affiliation: Urologic Consultants of Southeastern Pennsylvania, Bala Cynwyd, Pennsylvania.
authors.forename: Laurence H
authors.initials: LH
authors.lastname: Belkoff
authors.affiliation: San Diego Sexual Medicine, Alvarado Hospital, San Diego, California.
authors.forename: Irwin
authors.initials: I
authors.lastname: Goldstein
authors.affiliation: Auxilium Pharmaceuticals, Inc., Chesterbrook, Pennsylvania.
authors.forename: James P
authors.initials: JP
authors.lastname: Tursi
authors.affiliation: Auxilium Pharmaceuticals, Inc., Chesterbrook, Pennsylvania.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Uy
authors.affiliation: VIVUS, Inc., Mountain View, California.
authors.forename: Craig A
authors.initials: CA
authors.lastname: Peterson
authors.affiliation: Stanford University School of Medicine, Stanford, California.
authors.forename: Charles H
authors.initials: CH
authors.lastname: Bowden
authors.affiliation: VIVUS, Inc., Mountain View, California.
authors.forename: Wesley W
authors.initials: WW
authors.lastname: Day
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D054706:Cyclic Nucleotide Phosphodiesterases, Type 5; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection / Q000187:drug effects*; D011743:Pyrimidines / Q000008:administration & dosage*; D012725:Sexual Behavior / Q000187:drug effects*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D011743:Pyrimidines; C553414:avanafil; D054706:Cyclic Nucleotide Phosphodiesterases, Type 5
keywords: avanafil; clinical trials as topic; coitus; erectile dysfunction; phosphodiesterase 5 inhibitors