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

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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)280-289
Number of pages10
JournalWorld Journal of Men's Health
Volume39
DOIs
StatePublished - Jan 2021

Keywords

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

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this