Efficacy of Once-Daily Administration of Udenafil for 24 Weeks on Erectile Dysfunction: Results from a Randomized Multicenter Placebo-Controlled Clinical Trial

Ki Hak Moon, Young Hwii Ko, Sae Woong Kim, Du Geon Moon, Je-Jong Kim, Nam Cheol Park, Sung Won Lee, Jae Seung Paick, Tae Young Ahn, Woo Sik Chung, Kwon Sik Min, Jong Kwan Park, Dae Yul Yang, Kwangsung Park

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Introduction: 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. Aim: 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. Methods: This multicenter, randomized, double-blind clinical trial included 346 ED patients (placebo, udenafil 50mg, udenafil 75mg). Subjects were treated with each medication once daily for 24 weeks. Main Outcome Measures: 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. Results: 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 75mg 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 50mg and 47.0% for udenafil 75mg. In terms of safety, ADRs were observed in 6.1%, 12.9%, and 17.9% for placebo, udenafil 50mg, and 75mg, respectively. Although a statistically higher rate of ADRs was observed in the udenafil 75mg group (P=0.024), the majority were mild and recovered without treatment. Conclusions: Once-daily administration of udenafil 50mg and 75mg for 24 weeks resulted in improvement of EF. In particular, udenafil 75mg improves EF regardless of the baseline degree of ED.

Original languageEnglish
Pages (from-to)1194-1201
Number of pages8
JournalJournal of Sexual Medicine
Volume12
Issue number5
DOIs
Publication statusPublished - 2015 May 1

Fingerprint

udenafil
Controlled Clinical Trials
Erectile Dysfunction
Placebos
Drug-Related Side Effects and Adverse Reactions
Safety
Phosphodiesterase 5 Inhibitors

Keywords

  • Clinical Trial
  • Erectile Dysfunction
  • Phosphodiesterase 5 Inhibitors
  • Udenafil

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynaecology
  • Urology

Cite this

Efficacy of Once-Daily Administration of Udenafil for 24 Weeks on Erectile Dysfunction : Results from a Randomized Multicenter Placebo-Controlled Clinical Trial. / Moon, Ki Hak; Ko, Young Hwii; Kim, Sae Woong; Moon, Du Geon; Kim, Je-Jong; Park, Nam Cheol; Lee, Sung Won; Paick, Jae Seung; Ahn, Tae Young; Chung, Woo Sik; Min, Kwon Sik; Park, Jong Kwan; Yang, Dae Yul; Park, Kwangsung.

In: Journal of Sexual Medicine, Vol. 12, No. 5, 01.05.2015, p. 1194-1201.

Research output: Contribution to journalArticle

Moon, KH, Ko, YH, Kim, SW, Moon, DG, Kim, J-J, Park, NC, Lee, SW, Paick, JS, Ahn, TY, Chung, WS, Min, KS, Park, JK, Yang, DY & Park, K 2015, 'Efficacy of Once-Daily Administration of Udenafil for 24 Weeks on Erectile Dysfunction: Results from a Randomized Multicenter Placebo-Controlled Clinical Trial', Journal of Sexual Medicine, vol. 12, no. 5, pp. 1194-1201. https://doi.org/10.1111/jsm.12862
Moon, Ki Hak ; Ko, Young Hwii ; Kim, Sae Woong ; Moon, Du Geon ; Kim, Je-Jong ; Park, Nam Cheol ; Lee, Sung Won ; Paick, Jae Seung ; Ahn, Tae Young ; Chung, Woo Sik ; Min, Kwon Sik ; Park, Jong Kwan ; Yang, Dae Yul ; Park, Kwangsung. / Efficacy of Once-Daily Administration of Udenafil for 24 Weeks on Erectile Dysfunction : Results from a Randomized Multicenter Placebo-Controlled Clinical Trial. In: Journal of Sexual Medicine. 2015 ; Vol. 12, No. 5. pp. 1194-1201.
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abstract = "Introduction: 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. Aim: 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. Methods: This multicenter, randomized, double-blind clinical trial included 346 ED patients (placebo, udenafil 50mg, udenafil 75mg). Subjects were treated with each medication once daily for 24 weeks. Main Outcome Measures: 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. Results: 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 75mg 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 50mg and 47.0{\%} for udenafil 75mg. In terms of safety, ADRs were observed in 6.1{\%}, 12.9{\%}, and 17.9{\%} for placebo, udenafil 50mg, and 75mg, respectively. Although a statistically higher rate of ADRs was observed in the udenafil 75mg group (P=0.024), the majority were mild and recovered without treatment. Conclusions: Once-daily administration of udenafil 50mg and 75mg for 24 weeks resulted in improvement of EF. In particular, udenafil 75mg improves EF regardless of the baseline degree of ED.",
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AU - Ko, Young Hwii

AU - Kim, Sae Woong

AU - Moon, Du Geon

AU - Kim, Je-Jong

AU - Park, Nam Cheol

AU - Lee, Sung Won

AU - Paick, Jae Seung

AU - Ahn, Tae Young

AU - Chung, Woo Sik

AU - Min, Kwon Sik

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N2 - Introduction: 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. Aim: 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. Methods: This multicenter, randomized, double-blind clinical trial included 346 ED patients (placebo, udenafil 50mg, udenafil 75mg). Subjects were treated with each medication once daily for 24 weeks. Main Outcome Measures: 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. Results: 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 75mg 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 50mg and 47.0% for udenafil 75mg. In terms of safety, ADRs were observed in 6.1%, 12.9%, and 17.9% for placebo, udenafil 50mg, and 75mg, respectively. Although a statistically higher rate of ADRs was observed in the udenafil 75mg group (P=0.024), the majority were mild and recovered without treatment. Conclusions: Once-daily administration of udenafil 50mg and 75mg for 24 weeks resulted in improvement of EF. In particular, udenafil 75mg improves EF regardless of the baseline degree of ED.

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