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.
10.3346/jkms.2017.32.6.1016
- Author:
Hyun Jun PARK
1
;
Sae Woong KIM
;
Je Jong KIM
;
Sung Won LEE
;
Jae Seung PAICK
;
Tae Young AHN
;
Kwangsung PARK
;
Jong Kwan PARK
;
Nam Cheol PARK
Author Information
1. Department of Urology and Medical Research Institute of Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea. joon501@pusan.ac.kr
- Publication Type:Clinical Trial ; Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords:
Erectile Dysfunction;
Phosphodiesterase 5 Inhibitors;
Penile Erection
- MeSH:
Erectile Dysfunction*;
Humans;
Male;
Penile Erection;
Phosphodiesterase 5 Inhibitors
- From:Journal of Korean Medical Science
2017;32(6):1016-1023
- CountryRepublic of Korea
- Language:English
-
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. This is a clinical trial study and was registered at www.ClinicalTrials.gov (Identifier: NCT02477436).
