Detailed Information

Cited 0 time in webofscience Cited 0 time in scopus
Metadata Downloads

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
Apr-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.
Files in This Item
There are no files associated with this item.
Appears in
Collections
College of Medicine > Department of Medical Science > 1. Journal Articles

qrcode

Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.

Related Researcher

Researcher Moon, Du Geon photo

Moon, Du Geon
College of Medicine (Department of Medical Science)
Read more

Altmetrics

Total Views & Downloads

BROWSE