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Efficacy and safety of mirodenafil oro-dispersible film in Korean patients with erectile dysfunction: A double-blind, randomized, placebo-controlled, parallel-group, multicenter, phase IV studyEfficacy and Safety of Mirodenafil Oro-Dispersible Film in Korean Patients with Erectile Dysfunction: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Phase IV Study

Other Titles
Efficacy and Safety of Mirodenafil Oro-Dispersible Film in Korean Patients with Erectile Dysfunction: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Phase IV Study
Authors
Lee, S.W.Son, H.Lee, S.W.Cho, K.S.Moon, D.G.Yang, D.Y.Chung, W.S.Suh, J.-K.Park, H.J.Min, K.Moon, K.H.Park, K.Park, J.K.Hyun, J.S.Yang, S.-K.
Issue Date
4월-2022
Publisher
Korean Society for Sexual Medicine and Andrology
Keywords
Erectile dysfunction; Mirodenafil; Orally disintegrating formulations; Oro-dispersible film; Phosphodiesterase 5 inhibitors
Citation
World Journal of Men's Health, v.39, no.2, pp.1 - 10
Indexed
SCIE
SCOPUS
KCI
Journal Title
World Journal of Men's Health
Volume
39
Number
2
Start Page
1
End Page
10
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/140208
DOI
10.5534/WJMH.200157
ISSN
2287-4208
Abstract
Purpose: To investigate the efficacy, safety, and tolerability of oro-dispersible film (ODF) formulation of mirodenafil 50 mg and 100 mg for the treatment of patients with erectile dysfunction (ED) in Korea. Materials and Methods: A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 129 subjects was performed. Subjects were randomized to either placebo or mirodenafil ODF 50 mg or 100 mg to be taken in an on demandmanner for 8 weeks. The primary efficacy variable was the International Index of Erectile Dysfunction (IIEF)-5 questionnaire. The secondary efficacy variables comprised Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), the Global Assessment Question (GAQ), and the Life Satisfaction Checklist (LSC). Results: IIEF-5 was significantly increased in all groups after treatment. However, compared to the placebo group, only the mirodenafil ODF 100 mg group showed a significant difference. SEP2 and SEP3 were increased in both mirodenafil groups; however, the increase was not statistically significant for SEP2. In terms of GAQ and LSC, the mirodenafil ODF groups showed significant increases compared with the baseline. Most treatment-associated adverse events were mild and resolved spontaneously. Conclusions: Mirodenafil ODF is an effective and well-tolerated agent for the treatment of patients with ED in Korea. © 2021 Korean Society for Sexual Medicine and Andrology.
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