A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil in Subjects with Erectile Dysfunction
Article first published online: 16 JAN 2012
© 2012 International Society for Sexual Medicine
The Journal of Sexual Medicine
Volume 9, Issue 4, pages 1122–1133, April 2012
How to Cite
Goldstein, I., McCullough, A. R., Jones, L. A., Hellstrom, W. J., Bowden, C. H., DiDonato, K., Trask, B. and Day, W. W. (2012), A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil in Subjects with Erectile Dysfunction. Journal of Sexual Medicine, 9: 1122–1133. doi: 10.1111/j.1743-6109.2011.02629.x
- Issue published online: 28 MAR 2012
- Article first published online: 16 JAN 2012
- Erectile Dysfunction;
- Oral Phosphodiesterase Type 5 Inhibitor;
- Clinical Trial;
- On-Demand Treatment
Introduction. Phosphodiesterase type 5 (PDE5) inhibitors have become standard treatment for erectile dysfunction (ED).
Aim. To prospectively evaluate the safety and efficacy of avanafil, a novel PDE5 inhibitor, in men with mild to severe ED.
Methods. In this multicenter, double-blind, Phase 3 trial, 646 subjects were randomized to receive avanafil (50 mg, 100 mg, 200 mg) or placebo throughout a 12-week treatment period. Subjects were instructed to take study drug 30 minutes prior to initiation of sexual activity. At least a 12-hour separation time between doses was required; no restrictions were placed on food or alcohol intake.
Main Outcome Measures. Improvement in erectile function (EF) was measured by Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3) and by the EF domain of the International Index of Erectile Function (IIEF) questionnaire.
Results. Mean change in percentage of successful sexual attempts (SEP2 and SEP3) and IIEF-EF domain score significantly favored all doses of avanafil over placebo (P ≤ 0.001). Secondary analyses demonstrated achievement of successful intercourse by subjects within 15 minutes of dosing. Of the 300 sexual attempts made during this interval, 64% to 71% were successful in avanafil-treated subjects compared with 27% in placebo-treated subjects. Successful intercourse was also demonstrated >6 hours post dosing, with 59% to 83% of the 80 sexual attempts successful in avanafil-treated subjects compared with 25% of placebo-treated subjects. The most commonly reported adverse events in subjects taking avanafil included headache, flushing, and nasal congestion; there were no drug-related serious adverse events.
Conclusion. Following 12 weeks of avanafil treatment without food or alcohol restrictions, significant improvements in sexual function were observed with all 3 doses of avanafil compared with placebo. Successful intercourse was observed as early as 15 minutes and >6 hours after dosing in some subjects. Avanafil was generally well tolerated for the treatment of ED. Goldstein I, McCullough AR, Jones LA, Hellstrom WJ, Bowden CH, DiDonato K, Trask B, and Day WW. A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction. J Sex Med 12;9:1122–1133.