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

Affiliations
  • 1Department of Urology, Samsung Medical Center, Samsung Biomedical Research Institute, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 2Department of Urology, Seoul National University College of Medicine, Seoul, Korea.
  • 3Department of Urology, SMG-SNU Boramae Medical Center, Seoul, Korea.
  • 4Department of Urology, Hanyang University College of Medicine, Seoul, Korea.
  • 5Department of Urology, Gangnam Severance Hospital, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.
  • 6Department of Urology, Korea University College of Medicine, Seoul, Korea.
  • 7Department of Urology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
  • 8Department of Urology, Ewha Womans University School of Medicine, Seoul, Korea.
  • 9National Research Center for Sexual Medicine and Department of Urology, Inha University School of Medicine, Incheon, Korea.
  • 10Department of Urology, Pusan National University School of Medicine, Busan, Korea.
  • 11Medical Research Institute of Pusan National University Hospital, Busan, Korea.
  • 12Department of Urology, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.
  • 13Department of Urology, Yeungnam University College of Medicine, Daegu, Korea
  • 14Department of Urology, Chonnam National University Medical School, Gwangju, Korea
  • 15Department of Urology, Jeonbuk National University Medical School, Research Institute of Clinical Medicine of Jeonbuk National University – Biomedical Research Institute and Clinical Trial Center of Medical Device, Jeonbuk National University Hospital, Jeonju, Korea.
  • 16Department of Urology, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Korea.
  • 17Department of Urology, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.

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
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