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KMID : 1037120220400020280
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The World Journal of Men′s Health
2022 Volume.40 No. 2 p.280 ~ p.289
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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
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Lee Sung-Won
Son Hwan-Cheol
Lee Seung-Wook
Cho Kang-Su
Moon Du-Geon
Yang Dae-Yul
Chung Woo-Sik
Suh Jun-Kyu
Park Hyun-Jun
Min Kweon-Sik
Moon Ki-Hak
Park Kwang-Sung
Park Jong-Kwan
Hyun Jae-Seog
Yang Sang-Kuk
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Abstract
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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.
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KEYWORD
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Erectile dysfunction, Mirodenafil, Orally disintegrating formulations, Oro-dispersible film, Phosphodiesterase 5 inhibitors
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