A Phase 3 Study to Evaluate the 1-Year Efficacy and Safety of Udenafil 75 mg Once Daily in Patients With Erectile Dysfunction
DC Field | Value | Language |
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dc.contributor.author | Moon, Ki Hak | - |
dc.contributor.author | Kim, Sae Woong | - |
dc.contributor.author | Moon, Du Geon | - |
dc.contributor.author | Kim, Je Jong | - |
dc.contributor.author | Park, Nam Cheol | - |
dc.contributor.author | Lee, Sung Won | - |
dc.contributor.author | Paick, Jae-Seung | - |
dc.contributor.author | Ahn, Tai Young | - |
dc.contributor.author | Chung, Woo Sik | - |
dc.contributor.author | Min, Kwon Sik | - |
dc.contributor.author | Park, Jong Kwan | - |
dc.contributor.author | Yang, Dae Yul | - |
dc.contributor.author | Shin, Hong Seok | - |
dc.contributor.author | Park, Kwangsung | - |
dc.date.accessioned | 2021-09-03T21:32:55Z | - |
dc.date.available | 2021-09-03T21:32:55Z | - |
dc.date.created | 2021-06-18 | - |
dc.date.issued | 2016-08 | - |
dc.identifier.issn | 1743-6095 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/87968 | - |
dc.description.abstract | Introduction: Once-daily administration of phosphodiesterase type 5 inhibitors has been shown to correct erectile dysfunction (ED). Aim: To evaluate the long-term efficacy and safety after once-daily oral administration of udenafil 75 mg in men with ED. Methods: This clinical trial was an open-label, fixed-dose, 24-week extension study (DA8159_EDDL_III) of a 24-week double-blinded efficacy and safety study of once-daily udenafil (parent study: DA8159_EDD_III). Subjects received udenafil 75 mg once daily for 24 weeks during this extension study, and the follow-up visit occurred during the 4-week ED treatment-free period. Main Outcome Measures: Subjects were asked to complete the International Index of Erectile Function questionnaire and the Global Assessment Questionnaire at the 24-week extension and after the 4-week ED treatment-free period, and the development of adverse drug reactions was investigated. Results: In total, 302 subjects were enrolled in this extension study. Improvement was shown with an increased erectile function (EF) domain score compared with baseline (14.60 +/- 4.57) at extension week 48 (23.98 +/- 5.44) and a slight increase in EF domain score compared with the last time point (week 24) of the parent study (P < .001). The Global Assessment Questionnaire showed a high improvement rate of 95.4% at the extension 48-week time point. For shift to normal, almost half the subjects (45.1%) recovered "normal" EF, and 14.2% of subjects reported normal erections after the 4-week ED treatment-free period. The occurrence rate of adverse drug reactions was 8%, which consisted mainly of flushing and headache. Conclusion: Once-daily dosing of udenafil 75 mg showed excellent efficacy and safety with long-term administration and allowed a more spontaneous sexual life. Copyright (C) 2016, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | WILEY-BLACKWELL | - |
dc.subject | TADALAFIL 5 MG | - |
dc.subject | PDE5 INHIBITOR | - |
dc.subject | DIABETIC-RATS | - |
dc.subject | SILDENAFIL CITRATE | - |
dc.subject | DOUBLE-BLIND | - |
dc.subject | A-DAY | - |
dc.subject | MEN | - |
dc.subject | TRIAL | - |
dc.subject | REHABILITATION | - |
dc.subject | MULTICENTER | - |
dc.title | A Phase 3 Study to Evaluate the 1-Year Efficacy and Safety of Udenafil 75 mg Once Daily in Patients With Erectile Dysfunction | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Moon, Du Geon | - |
dc.contributor.affiliatedAuthor | Kim, Je Jong | - |
dc.identifier.doi | 10.1016/j.jsxm.2016.05.011 | - |
dc.identifier.scopusid | 2-s2.0-84994793920 | - |
dc.identifier.wosid | 000384729500013 | - |
dc.identifier.bibliographicCitation | JOURNAL OF SEXUAL MEDICINE, v.13, no.8, pp.1263 - 1269 | - |
dc.relation.isPartOf | JOURNAL OF SEXUAL MEDICINE | - |
dc.citation.title | JOURNAL OF SEXUAL MEDICINE | - |
dc.citation.volume | 13 | - |
dc.citation.number | 8 | - |
dc.citation.startPage | 1263 | - |
dc.citation.endPage | 1269 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Urology & Nephrology | - |
dc.relation.journalWebOfScienceCategory | Urology & Nephrology | - |
dc.subject.keywordPlus | TADALAFIL 5 MG | - |
dc.subject.keywordPlus | PDE5 INHIBITOR | - |
dc.subject.keywordPlus | DIABETIC-RATS | - |
dc.subject.keywordPlus | SILDENAFIL CITRATE | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | A-DAY | - |
dc.subject.keywordPlus | MEN | - |
dc.subject.keywordPlus | TRIAL | - |
dc.subject.keywordPlus | REHABILITATION | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordAuthor | Erectile Dysfunction | - |
dc.subject.keywordAuthor | Phosphodiesterase Type 5 Inhibitors | - |
dc.subject.keywordAuthor | Udenafil | - |
dc.subject.keywordAuthor | Long Term | - |
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