PURPOSE: To examine the therapeutic effects of avanafil 15 minutes after dosing in men with mild to severe ED.
MATERIALS AND METHODS: This randomized, double-blind, placebo-controlled 12-week study (4-week run-in; 8-week treatment period) randomized men to placebo (n=145), avanafil 100 mg (n=147), or avanafil 200 mg (n=148) on demand. The primary efficacy variable was the per-subject proportion of sexual attempts within the treatment period in which subjects obtained an erection sufficient for vaginal penetration within approximately 15 minutes after dosing (measured by stopwatch) that enabled successful completion of sexual intercourse (Sexual Encounter Profile question 3 [SEP3]).
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 [SE], 28.2% [2.9]) vs placebo (mean, 14.9% LS mean [SE], 13.8% [2.9], p=0.001 and p< 0.001). After treatment, a statistically significant difference between avanafil and placebo in the average per-subject proportion of successful intercourse attempts (SEP3) was noted 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; most were mild or moderate in severity.
CONCLUSIONS: Treatment with avanafil produced efficacy, compared with placebo, within approximately 15 minutes of dosing, and a statistically significant treatment difference in the percentage of successful sexual attempts was demonstrated as early as 10 minutes after treatment.
Written by:
Hellstrom WJ, Kaminetsky J, Belkoff LH, Goldstein I, Tursi JP, Uy J, Peterson CA, Bowden CH, Day WW. Are you the author?
Tulane University School of Medicine, New Orleans, LA; University Urology Associates, New York, NY; Urologic Consultants of Southeastern Pennsylvania, Bala Cynwyd, PA; San Diego Sexual Medicine, Alvarado Hospital, San Diego, CA; Auxilium Pharmaceuticals, Inc., Chesterbrook, PA; VIVUS, Inc., Mountain View, CA; Stanford University School of Medicine, Stanford, CA.
Reference: J Urol. 2015 Jan 12. pii: S0022-5347(15)00019-1.
doi: 10.1016/j.juro.2014.12.101
PubMed Abstract
PMID: 25591992