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
DC Field | Value | Language |
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dc.contributor.author | Lee, S.W. | - |
dc.contributor.author | Son, H. | - |
dc.contributor.author | Lee, S.W. | - |
dc.contributor.author | Cho, K.S. | - |
dc.contributor.author | Moon, D.G. | - |
dc.contributor.author | Yang, D.Y. | - |
dc.contributor.author | Chung, W.S. | - |
dc.contributor.author | Suh, J.-K. | - |
dc.contributor.author | Park, H.J. | - |
dc.contributor.author | Min, K. | - |
dc.contributor.author | Moon, K.H. | - |
dc.contributor.author | Park, K. | - |
dc.contributor.author | Park, J.K. | - |
dc.contributor.author | Hyun, J.S. | - |
dc.contributor.author | Yang, S.-K. | - |
dc.date.accessioned | 2022-04-13T05:41:59Z | - |
dc.date.available | 2022-04-13T05:41:59Z | - |
dc.date.created | 2022-04-12 | - |
dc.date.issued | 2022-04 | - |
dc.identifier.issn | 2287-4208 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/140208 | - |
dc.description.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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | Korean Society for Sexual Medicine and Andrology | - |
dc.title | 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 | - |
dc.title.alternative | 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 | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Moon, D.G. | - |
dc.identifier.doi | 10.5534/WJMH.200157 | - |
dc.identifier.scopusid | 2-s2.0-85101516282 | - |
dc.identifier.wosid | 000708881300001 | - |
dc.identifier.bibliographicCitation | World Journal of Men's Health, v.39, no.2, pp.1 - 10 | - |
dc.relation.isPartOf | World Journal of Men's Health | - |
dc.citation.title | World Journal of Men's Health | - |
dc.citation.volume | 39 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 1 | - |
dc.citation.endPage | 10 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.identifier.kciid | ART002827334 | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
dc.relation.journalResearchArea | Endocrinology & Metabolism | - |
dc.relation.journalResearchArea | Health Care Sciences & Services | - |
dc.relation.journalResearchArea | Urology & Nephrology | - |
dc.relation.journalWebOfScienceCategory | Andrology | - |
dc.relation.journalWebOfScienceCategory | Health Care Sciences & Services | - |
dc.relation.journalWebOfScienceCategory | Urology & Nephrology | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | TABLET | - |
dc.subject.keywordPlus | MEN | - |
dc.subject.keywordPlus | FORMULATION | - |
dc.subject.keywordPlus | MANAGEMENT | - |
dc.subject.keywordPlus | SILDENAFIL | - |
dc.subject.keywordPlus | INHIBITORS | - |
dc.subject.keywordAuthor | Erectile dysfunction | - |
dc.subject.keywordAuthor | Mirodenafil | - |
dc.subject.keywordAuthor | Orally disintegrating formulations | - |
dc.subject.keywordAuthor | Oro-dispersible film | - |
dc.subject.keywordAuthor | Phosphodiesterase 5 inhibitors | - |
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