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Lee Sung Won,Son Hwancheol,Lee Seung Wook,Cho Kang Su,문두건,Yang Dae Yul,Chung Woo Sik,Suh Jun-Kyu,Park Hyun Jun,Min Kweonsik,Moon Ki Hak,Park Kwangsung,Park Jong Kwan,Hyun Jae Seog,Yang Sang-Kuk 대한남성과학회 2022 The World Journal of Men's Health Vol.40 No.2
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:Materials and Methods: A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 129 subjects was per-formed. 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:Results: IIEF-5 was significantly increased in all groups after treatment. However, compared to the placebo group, only the mirode-nafil 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:Conclusions: Mirodenafil ODF is an effective and well-tolerated agent for the treatment of patients with ED in Korea.