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
| Autor: | Sung Won Lee, Hwancheol Son, Seung Wook Lee, Kang Su Cho, Du Geon Moon, Dae Yul Yang, Woo Sik Chung, Jun-Kyu Suh, Hyun Jun Park, Kweonsik Min, Ki Hak Moon, Kwangsung Park, Jong Kwan Park, Jae Seog Hyun, Sang-Kuk Yang |
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| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | The World Journal of Men's Health, Vol 40, Iss 2, Pp 280-289 (2022) |
| Druh dokumentu: | article |
| ISSN: | 2287-4208 2287-4690 |
| DOI: | 10.5534/wjmh.200157 |
| Popis: | 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. |
| Databáze: | Directory of Open Access Journals |
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