World J Mens Health.  2022 Apr;40(2):280-289. 10.5534/wjmh.200157.

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

• Lee SW
• Son H
• Lee SW
• Cho KS
• Moon DG
• Yang DY
• Chung WS
• Suh JK
• Park HJ
• Min K
• Moon KH
• Park K
• Park JK
• Hyun JS
• Yang SK

• KMID: 2527326
• DOI: http://doi.org/10.5534/wjmh.200157

Abstract

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.

Keyword

Erectile dysfunction; Mirodenafil; Orally disintegrating formulations; Oro-dispersible film; Phosphodiesterase 5 inhibitors