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A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Therapeutic Confirmatory Study to Evaluate the Safety and Efficacy of Avanafil in Korean Patients with Erectile Dysfunction

Authors
Park, Hyun JunKim, Sae WoongKim, Je JongLee, Sung WonPaick, Jae SeungAhn, Tae YoungPark, KwangsungPark, Jong KwanPark, Nam Cheol
Issue Date
6월-2017
Publisher
KOREAN ACAD MEDICAL SCIENCES
Keywords
Erectile Dysfunction; Phosphodiesterase 5 Inhibitors; Penile Erection
Citation
JOURNAL OF KOREAN MEDICAL SCIENCE, v.32, no.6, pp.1016 - 1023
Indexed
SCIE
SCOPUS
KCI
Journal Title
JOURNAL OF KOREAN MEDICAL SCIENCE
Volume
32
Number
6
Start Page
1016
End Page
1023
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/83352
DOI
10.3346/jkms.2017.32.6.1016
ISSN
1011-8934
Abstract
A multi-center, randomized, double-blind, placebo-controlled study was conducted with 158 subjects who were randomized to placebo or avanafil 50, 100, and 200 mg on demand for 8 weeks to evaluate the safety, tolerability, and efficacy of avanafil in the treatment of erectile dysfunction (ED) in Korean men. The primary outcome was the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) questionnaire. Secondary outcomes included changes in the scores of IIEF questions 3 and 4 (IIEF Q3, Q4) from baseline, changes in all domain scores in the IIEF from baseline, Sexual Encounter Profile questions 2-5 (SEP2-5), the Global Efficacy Assessment Question (GEAQ), and the number of subjects whose EF domain score at the 8th week visit was >= 26. After 8 weeks of treatment, the dose groups except avanafil 50 mg scored significantly higher on the IIEF-EF domain from baseline than the placebo group. The changes from baseline in the avanafil group in IIEF Q3 (all doses) and Q4 (200 mg alone) were higher than the placebo group. The differences between avanafil and placebo groups were significant in SEP2 (100 and 200 mg) and SEP3-5 (200 mg). The differences in the GEAQ "Yes" response were also significant in the avanafil 100 and 200 mg groups. Regarding the ratio of normal EF at the end of the study, avanafil 200 mg differed significantly from the placebo. Most treatment-associated adverse events were mild and resolved spontaneously.
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