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
- Title
- 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
- Author
- 이승욱
- Keywords
- Erectile dysfunction; Mirodenafil; Orally disintegrating formulations; Oro-dispersible film; Phosphodiesterase 5 inhibitors
- Issue Date
- 2021-01
- Publisher
- Korean Society for Sexual Medicine and Andrology
- Citation
- The World Journal of Men's Health, v. 40, no. 2, Page. 280-289
- 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.
- URI
- https://wjmh.org/DOIx.php?id=10.5534/wjmh.200157#https://repository.hanyang.ac.kr/handle/20.500.11754/175439
- ISSN
- 2287-4208; 2287-4690
- DOI
- 10.5534/wjmh.200157
- Appears in Collections:
- COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
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