Evidence map›Paper›PMID 33987996›Full record

ArticleThe world journal of men's health2022

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 and 5 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The world journal of men's health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Investigative and clinical urology · 2023
    Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Sung Won LeeDepartment of Urology, Samsung Medical Center, Samsung Biomedical Research Institute, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-6608-9050
Hwancheol SonDepartment of Urology, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-5033-0153
Seung Wook LeeDepartment of Urology, Hanyang University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-4818-5847
Kang Su ChoDepartment of Urology, Gangnam Severance Hospital, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-3500-8833
Du Geon MoonDepartment of Urology, Korea University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-9031-9845
Dae Yul YangDepartment of Urology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-7331-302X
Woo Sik ChungDepartment of Urology, Ewha Womans University School of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-6413-8779
Jun-Kyu SuhNational Research Center for Sexual Medicine and Department of Urology, Inha University School of Medicine, Incheon, Korea.ORCID https://orcid.org/0000-0002-1812-9449
Hyun Jun ParkDepartment of Urology, Pusan National University School of Medicine, Busan, Korea.ORCID https://orcid.org/0000-0003-0566-9574
Kweonsik MinDepartment of Urology, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.ORCID https://orcid.org/0000-0002-8506-9706
Ki Hak MoonDepartment of Urology, Yeungnam University College of Medicine, Daegu, Korea.ORCID https://orcid.org/0000-0002-8193-9022
Kwangsung ParkDepartment of Urology, Chonnam National University Medical School, Gwangju, Korea.ORCID https://orcid.org/0000-0001-8827-162X
Jong Kwan ParkDepartment 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.ORCID https://orcid.org/0000-0001-9682-2081
Jae Seog HyunDepartment of Urology, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Korea.ORCID https://orcid.org/0000-0002-8820-4117
Sang-Kuk YangDepartment of Urology, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.ORCID https://orcid.org/0000-0002-7377-0992

Funding

Pusan National UniversitySK Chemicals SMC-MODF-01
6 · The paper itself

Abstract

purposeTo 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

methodsA 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).

resultsIIEF-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.

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

Indexed as

Erectile dysfunctionMirodenafilOrally disintegrating formulationsOro-dispersible filmPhosphodiesterase 5 inhibitors

Identifiers

PMID33987996
PMCPMC8987134

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.