Cited 2 times in
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 | 조강수 | - |
dc.date.accessioned | 2021-09-29T00:46:20Z | - |
dc.date.available | 2021-09-29T00:46:20Z | - |
dc.date.issued | 2021-01 | - |
dc.identifier.issn | 2287-4208 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/184028 | - |
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 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. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | 대한남성과학회 | - |
dc.relation.isPartOf | WORLD JOURNAL OF MENS HEALTH | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
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.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Urology (비뇨의학교실) | - |
dc.contributor.googleauthor | Sung Won Lee | - |
dc.contributor.googleauthor | Hwancheol Son | - |
dc.contributor.googleauthor | Seung Wook Lee | - |
dc.contributor.googleauthor | Kang Su Cho | - |
dc.contributor.googleauthor | Du Geon Moon | - |
dc.contributor.googleauthor | Dae Yul Yang | - |
dc.contributor.googleauthor | Woo Sik Chung | - |
dc.contributor.googleauthor | Jun Kyu Suh | - |
dc.contributor.googleauthor | Hyun Jun Park | - |
dc.contributor.googleauthor | Kweonsik Min | - |
dc.contributor.googleauthor | Ki Hak Moon | - |
dc.contributor.googleauthor | Kwangsung Park | - |
dc.contributor.googleauthor | Jong Kwan Park | - |
dc.contributor.googleauthor | Jae Seog Hyun | - |
dc.contributor.googleauthor | Sang Kuk Yang | - |
dc.identifier.doi | 10.5534/wjmh.200157 | - |
dc.contributor.localId | A03801 | - |
dc.relation.journalcode | J02798 | - |
dc.identifier.eissn | 2287-4690 | - |
dc.identifier.pmid | 33987996 | - |
dc.subject.keyword | Erectile dysfunction | - |
dc.subject.keyword | Mirodenafil | - |
dc.subject.keyword | Orally disintegrating formulations | - |
dc.subject.keyword | Oro-dispersible film | - |
dc.subject.keyword | Phosphodiesterase 5 inhibitors | - |
dc.contributor.alternativeName | Cho, Kang Su | - |
dc.contributor.affiliatedAuthor | 조강수 | - |
dc.citation.volume | 39 | - |
dc.citation.startPage | e3 | - |
dc.identifier.bibliographicCitation | WORLD JOURNAL OF MENS HEALTH, Vol.39 : e3, 2021-01 | - |
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