Efficacy of once-daily administration of udenafil for 24 weeks on erectile dysfunction: results from a randomized multicenter placebo-controlled clinical trial

The Journal of Sexual Medicine
Ki Hak MoonKwangsung Park

Abstract

The method of administration of oral phosphodiesterase-5 inhibitors has been expanded to once-daily repeated administration with lower initial dosage than on-demand administration. The aim of this study was to evaluate the efficacy and safety of once-daily udenafil as a treatment for erectile dysfunction (ED) for intermediate-term period. This multicenter, randomized, double-blind clinical trial included 346 ED patients (placebo, udenafil 50 mg, udenafil 75 mg). Subjects were treated with each medication once daily for 24 weeks. Subjects were asked to complete the International Index of Erectile Function (IIEF)-erectile function (EF) domain at baseline, 12 weeks, and 24 weeks and the development of adverse drug reactions (ADRs) was inspected. Both dosages of udenafil induced a significant increase in IIEF-EF compared with placebo at both 12 and 24 weeks. When patients were divided according to the severity of baseline EF score, significant improvement was observed only with udenafil 75 mg regardless of the degree of ED. At 24 weeks, the proportions of patients who reported a return to normal EF (IIEF-EF over 26) were 39.1% for udenafil 50 mg and 47.0% for udenafil 75 mg. In terms of safety, ADRs were observed in 6.1%, 12.9%, an...Continue Reading

References

Jan 4, 2003·Archives of Pharmacal Research·Hyounmie DohWon Bae Kim
Mar 6, 2008·British Journal of Clinical Pharmacology·Bo-Hyung KimIn-Jin Jang
May 21, 2009·The Journal of Sexual Medicine·Rebecca WrishkoJames McGill

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Citations

Mar 24, 2016·Journal of Clinical Pharmacology·Hyang-Ki ChoiJae-Gook Shin
Jan 18, 2019·The Aging Male : the Official Journal of the International Society for the Study of the Aging Male·Kyungtae KoDae Yul Yang
Nov 23, 2017·The World Journal of Men's Health·Seong Yul RyuYong Woon Kim
Jun 8, 2017·The Aging Male : the Official Journal of the International Society for the Study of the Aging Male·Ecem KayaSerap Gur
Dec 5, 2020·Expert Opinion on Pharmacotherapy·Ahmed M BakrAhmed I El-Sakka
Jun 21, 2021·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Camilla Regina de Souza MadeiraRoberto Pontarolo

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