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 studyopen access
- Authors
- Lee, Sung Won; Son, Hwancheol; Lee, Seung Wook; Cho, Kang Su; Moon, Du Geon; Yang, Dae Yul; Chung, Woo Sik; Suh, Jun-Kyu; Park, Hyun Jun; Min, Kweonsik; Moon, Ki Hak; Park, Kwangsung; Park, Jong Kwan; Hyun, Jae Song; Yang, Sang-Kuk
- 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.40, no.2, pp 280 - 289
- Pages
- 10
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- World Journal of Men's Health
- Volume
- 40
- Number
- 2
- Start Page
- 280
- End Page
- 289
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/51968
- DOI
- 10.5534/WJMH.200157
- ISSN
- 2287-4208
2287-4690
- 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 demand” manner 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.
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Collections - 2. Clinical Science > Department of Urology > 1. Journal Articles
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