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논문 기본 정보

자료유형
학술저널
저자정보
박현준 (부산대학교) 김세웅 (가톨릭대학교) 김제종 (고려대학교) 이성원 (성균관대학교) 백재승 (서울대학교) 안태영 (울산대학교) 박광성 (전남대학교) 박종관 (전북대학교) 박남철 (부산대학교)
저널정보
대한의학회 Journal of Korean Medical Science Journal of Korean Medical Science Vol.32 No.6
발행연도
2017.1
수록면
1,016 - 1,023 (8page)

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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. This is a clinical trial study and was registered at www.ClinicalTrials.gov (Identifier: NCT02477436).

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