Efficacy and safety of mirodenafil, A new oral phosphodiesterase type 5 inhibitor, for treatment of erectile dysfunction

Jae Seung Paick, Tai Y. Ahn, Hyung K. Choi, Woo Sik Chung, Je-Jong Kim, Sae C. Kim, Sae W. Kim, Sung W. Lee, Kweon S. Min, Ki H. Moon, Jong K. Park, Kwangsung Park, Nam C. Park, Jun Kyu Suh, Dae Y. Yang, Hyung Gi Jung

    Research output: Contribution to journalArticlepeer-review

    75 Citations (Scopus)


    Introduction. Mirodenafil is a newly developed oral phosphodiesterase type 5 inhibitor, currently under investigation as a treatment for erectile dysfunction (ED). Aim. We investigated the efficacy and safetyof on demand mirodenafil therapy at fixed doses (50 and 100mg) in Korean men with a broad range of ED. Methods. A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study was conducted with 223 subjects who were randomized to placebo or mirodenafil at fixed doses of 50 or 100mg for 12 weeks on an "as needed" basis. Main Outcome Measures. Primary efficacy measures were scores on the International Index of Erectile Function (IIEF) Question 3 (Q3) and Question 4 (Q4). Secondary efficacy measures included all domain scores of the IIEF, Sexual Encounter Profile Question 2 (SEP2), Sexual Encounter Profile Question 3 (SEP3), the Global Assessment Question (GAQ), and the Life Satisfaction Checklist (LSC). Safety assessments included laboratory tests, vital signs, physical examination, 12-lead electrocardiogram recordings, and patients' reporting of adverse events. Results. Mirodenafil 50 and 100 mg groups showed a significantly greaterincrease in IIEF Q3 (P = 0.0001, P <0.0001, respectively) and Q4 scores (both P <0.0001) at the end point compared with the placebo group. And mirodenafil in both doses significantly improved the scores of all five domains of the IIEF, SEP2, and SEP3 as well as the percentages of patients responding positively to the GAQ compared with the placebo group. As for LSC scores, the two mirodenafil groups showed significantly greater improvements in items regarding life as a whole, sexual life, and partner relationship than the placebo group. Most treatment-associated adverse events were of mild intensity, resolving spontaneously. Conclusions. Mirodenafil, in doses of 50 or 100 mg, significantly improved erectile function and were well tolerated in a representative population of Korean men with broad-spectrum ED of various etiologies and severities.

    Original languageEnglish
    Pages (from-to)2672-2680
    Number of pages9
    JournalJournal of Sexual Medicine
    Issue number11
    Publication statusPublished - 2008 Jan 1


    • Erectile Dysfunction
    • Mirodenafil
    • PDE5

    ASJC Scopus subject areas

    • Reproductive Medicine
    • Obstetrics and Gynaecology
    • Urology


    Dive into the research topics of 'Efficacy and safety of mirodenafil, A new oral phosphodiesterase type 5 inhibitor, for treatment of erectile dysfunction'. Together they form a unique fingerprint.

    Cite this