Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction: Results of a multicenter, randomized, double-blind, placebo-controlled trial - Abstract

Department of Urology, Chonbuk National University Medical School, Jeonju, Korea.

Institute for Medical Sciences, Chonbuk National University, and Research Institute and CTC for Medical Device of Chonbuk National University Hospital, Jeonju, Korea.



A once-daily dosing regimen with a phosphodiesterase type 5 inhibitor is needed for the treatment of erectile dysfunction (ED), in part because of the behavioral complexities associated with sexual intimacy. Many patients prefer spontaneous rather than scheduled sexual activities or they anticipate frequent sexual encounters. The pharmacokinetic profiles of udenafil with a time of maximal concentration of 1.0-1.5h and a terminal half-life of 11-13h make udenafil a good candidate for once-daily dosing.

To evaluate the efficacy and safety of once-daily dosing of udenafil in the treatment of ED.

This multicenter randomized double-blind, placebo-controlled, fix-dosed clinical trial involved 237 patients with ED. The subjects, who were treated with placebo or udenafil (25mg, 50mg, or 75mg) once daily for 12 wk, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ) during the study.

The primary outcome parameter was the change from baseline for the IIEF erectile function domain (EFD) score. The secondary outcome parameters were SEP questions 2 and 3, the shift to normal rate (EFD ≥26), and the response to the GAQ.

Compared with placebo, patients who took 50mg or 75mg of udenafil had a significantly improved IIEF-EFD score. Similar results were observed in comparing questions 2 and 3 in the SEP diary and the GAQ. Flushing was the most common treatment-related adverse event, which was transient and mild to moderate in severity.

Udenafil significantly improved erectile function among ED patients when administered in doses of 50mg or 75mg once daily for 12 wk. Daily administration of udenafil (50mg) may be another treatment option for ED.

Written by:
Zhao C, Kim SW, Yang DY, Kim JJ, Park NC, Lee SW, Paick JS, Ahn TY, Min KS, Park K, Park JK.   Are you the author?

Reference: Eur Urol. 2011 Mar 30. Epub ahead of print.
doi: 10.1016/j.eururo.2011.03.025

PubMed Abstract
PMID: 21458153

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