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.

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.

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).

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.

Mirodenafil ODF is an effective and well-tolerated agent for the treatment of patients with ED in Korea.

The world journal of men's health. 2021 Jan 21 [Epub ahead of print]

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

Department of Urology, Samsung Medical Center, Samsung Biomedical Research Institute, Sungkyunkwan University School of Medicine, Seoul, Korea., Department of Urology, Seoul National University College of Medicine, Seoul, Korea., Department of Urology, Hanyang University College of Medicine, Seoul, Korea., Department of Urology, Gangnam Severance Hospital, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea., Department of Urology, Korea University College of Medicine, Seoul, Korea., Department of Urology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea., Department of Urology, Ewha Womans University School of Medicine, Seoul, Korea., National Research Center for Sexual Medicine and Department of Urology, Inha University School of Medicine, Incheon, Korea., Department of Urology, Pusan National University School of Medicine, Busan, Korea., Department of Urology, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea., Department of Urology, Yeungnam University College of Medicine, Daegu, Korea., Department of Urology, Chonnam National University Medical School, Gwangju, Korea., Department 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., Department of Urology, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Korea., Department of Urology, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.

email news signup