Efficacy and Safety of Mirodenafil Oro-Dispersible Film in Korean Patients with Erectile Dysfunctionopen access
- Lee, Sung Won; Son, Hwancheol; Lee, Seung Wook; Cho, Kang Su; Moon, Du Geon; 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
- Issue Date
- KOREAN SOC SEXUAL MEDICINE & ANDROLOGY
- Erectile dysfunction; Mirodenafil; Orally disintegrating formulations; Oro-dispersible film; Phosphodiesterase 5 inhibitors
- WORLD JOURNAL OF MENS HEALTH, v.40, no.2, pp.280 - 289
- Journal Title
- WORLD JOURNAL OF MENS HEALTH
- Start Page
- End Page
- 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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