A Phase 3 Study to Evaluate the 1-Year Efficacy and Safety of Udenafil 75 mg Once Daily in Patients With Erectile Dysfunction.
Once-daily administration of phosphodiesterase type 5 inhibitors has been shown to correct erectile dysfunction (ED).



To evaluate the long-term efficacy and safety after once-daily oral administration of udenafil 75 mg in men with ED.



This clinical trial was an open-label, fixed-dose, 24-week extension study (DA8159_EDDL_III) of a 24-week double-blinded efficacy and safety study of once-daily udenafil (parent study: DA8159_EDD_III). Subjects received udenafil 75 mg once daily for 24 weeks during this extension study, and the follow-up visit occurred during the 4-week ED treatment-free period.



Subjects were asked to complete the International Index of Erectile Function questionnaire and the Global Assessment Questionnaire at the 24-week extension and after the 4-week ED treatment-free period, and the development of adverse drug reactions was investigated.



In total, 302 subjects were enrolled in this extension study. Improvement was shown with an increased erectile function (EF) domain score compared with baseline (14.60 ± 4.57) at extension week 48 (23.98 ± 5.44) and a slight increase in EF domain score compared with the last time point (week 24) of the parent study (P < .001). The Global Assessment Questionnaire showed a high improvement rate of 95.4% at the extension 48-week time point. For shift to normal, almost half the subjects (45.1%) recovered "normal" EF, and 14.2% of subjects reported normal erections after the 4-week ED treatment-free period. The occurrence rate of adverse drug reactions was 8%, which consisted mainly of flushing and headache.



Once-daily dosing of udenafil 75 mg showed excellent efficacy and safety with long-term administration and allowed a more spontaneous sexual life.
Department of Urology, College of Medicine, Yeungnam University, Daegu, Korea.
Ki Hak
KH
Moon
Department of Urology, The Catholic University of Korea College of Medicine, Seoul, Korea.
Sae Woong
SW
Kim
Department of Urology, College of Medicine, Korea University, Seoul, Korea.
Du Geon
du G
Moon
Department of Urology, College of Medicine, Korea University, Seoul, Korea.
Je Jong
JJ
Kim
Department of Urology, Pusan National University School of Medicine, Busan, Korea.
Nam Cheol
NC
Park
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Sung Won
SW
Lee
Department of Urology, Seoul National University Medical School, Seoul, Korea.
Jae-Seung
JS
Paick
Department of Urology, Asan Medical Center, Ulsan University School of Medicine, Seoul, Korea.
Tai Young
TY
Ahn
Department of Urology, Ewha Womans University School of Medicine, Seoul, Korea.
Woo Sik
WS
Chung
Department of Urology, College of Medicine, Inje University, Pusan, Korea.
Kwon Sik
KS
Min
Department of Urology, Chonbuk National University Medical School, Jeonju, Korea.
Jong Kwan
JK
Park
Department of Urology, College of Medicine, Hallym University, Seoul, Korea.
Dae Yul
DY
Yang
Department of Urology, Catholic University of Daegu School of Medicine, Daegu, Korea.
Hong Seok
HS
Shin
Department of Urology, Chonnam National University Medical School, Gwangju, Korea. Electronic address: uropark@gmail.com.
Kwangsung
K
Park
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000188:drug therapy*; D020773:Headache Disorders / Q000139:chemically induced; D006801:Humans; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D010410:Penile Erection / Q000187:drug effects; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011743:Pyrimidines / Q000008:administration & dosage* / Q000009:adverse effects; D012725:Sexual Behavior; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D000096926:Benzenesulfonamides
D058986:Phosphodiesterase 5 Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; C419664:udenafil; D000096926:Benzenesulfonamides
Erectile Dysfunction; Long Term; Phosphodiesterase Type 5 Inhibitors; Udenafil