A phase II, single-blind, randomized, crossover evaluation of the safety and efficacy of avanafil using visual sexual stimulation in patients with mild to moderate erectile dysfunction

Wayne J.G. Hellstrom, Matthew T. Freier, Ege Can Serefoglu, Ronald W Lewis, Karen Didonato, Craig A. Peterson

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Objective: To evaluate the safety, efficacy and time course of three doses of avanafil (50 mg, 100 mg and 200 mg) compared with sildenafil 50 mg or placebo, given in conjunction with visual sexual stimulation (VSS) videos in men with mild to moderate erectile dysfunction (ED). Patients and Methods: Male patients, 35-70 years of age, with mild to moderate ED of ≥6 months duration, were included in the study. During the course of the study, each patient received placebo, active control (sildenafil 50 mg), and one dose of avanafil (50 mg, 100 mg or 200 mg), all administered in random order at least 72 h apart. RigiScan® (Dacomed Corp., Minneapolis, MN, USA) monitoring was used in conjunction with 20-min VSS videos (20, 60, and 100 min after dosing) to determine the duration of and time to ≥60% penile rigidity, maximum rigidity, tumescent activity units (TAUs), rigidity activity units (RAUs), and responses to the five-point Erection Assessment Scale. Safety assessments included adverse events (AEs), vital sign changes in response to dosing, laboratory results (complete blood counts, chemistry panel, prostate-specific antigen, serum testosterone, prothrombin time and urine analysis) and physical examination findings. Results: Eighty-three patients were randomized and received at least one dose of study medication; 82 patients completed the study. Peak response to avanafil occurred in the early interval (20-40 min after dosing), while peak response to sildenafil occurred either in the middle (60-80 min) or late (100-120 min) intervals after dosing. Results were qualitatively similar for all other efficacy endpoints. During the 20-40-min interval, the majority of values for TAUs and RAUs with the avanafil 50-mg, 100-mg and 200-mg treatments were significantly superior to placebo (P < 0.05). Avanafil treatment was generally well tolerated; facial flushing (7-15%) was the most commonly observed AE, and no visual disturbances were reported. Conclusion: A favourable safety profile and improvement in sexual function, coupled with rapid onset of action and durability of effect, make avanafil an attractive option for males with ED, especially in the setting of on-demand treatment.

Original languageEnglish (US)
Pages (from-to)137-147
Number of pages11
JournalBJU International
Volume111
Issue number1
DOIs
StatePublished - Jan 1 2013

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Photic Stimulation
Erectile Dysfunction
Safety
Placebos
Blood Cell Count
Vital Signs
Prothrombin Time
Prostate-Specific Antigen
Physical Examination
Testosterone
avanafil
Therapeutics
Urine
Serum
Sildenafil Citrate

Keywords

  • RigiScan®
  • avanafil
  • erectile dysfunction
  • oral phosphodiesterase type 5 inhibitor
  • phase II study

ASJC Scopus subject areas

  • Urology

Cite this

A phase II, single-blind, randomized, crossover evaluation of the safety and efficacy of avanafil using visual sexual stimulation in patients with mild to moderate erectile dysfunction. / Hellstrom, Wayne J.G.; Freier, Matthew T.; Serefoglu, Ege Can; Lewis, Ronald W; Didonato, Karen; Peterson, Craig A.

In: BJU International, Vol. 111, No. 1, 01.01.2013, p. 137-147.

Research output: Contribution to journalArticle

Hellstrom, Wayne J.G. ; Freier, Matthew T. ; Serefoglu, Ege Can ; Lewis, Ronald W ; Didonato, Karen ; Peterson, Craig A. / A phase II, single-blind, randomized, crossover evaluation of the safety and efficacy of avanafil using visual sexual stimulation in patients with mild to moderate erectile dysfunction. In: BJU International. 2013 ; Vol. 111, No. 1. pp. 137-147.
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