Efficacy of Once-Daily Administration of Udenafil for 24 Weeks on Erectile Dysfunction: Results from a Randomized Multicenter Placebo-Controlled Clinical Trial |
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| Institution: | 1. Department of UrologyCollege of MedicineYeungnam UniversityDaeguKorea;2. Department of UrologyThe Catholic University of Korea College of MedicineSeoulKorea;3. Department of UrologyCollege of MedicineKorea UniversitySeoulKorea;4. Department of UrologyPusan National University School of MedicineBusanKorea;5. Department of UrologySamsung Medical CenterSungkyunkwan University School of MedicineSeoulKorea;6. Department of UrologySeoul National University Medical SchoolSeoulKorea;7. Department of UrologyAsan Medical CenterUlsan University School of MedicineSeoulKorea;8. Department of the UrologyEwha Womans University School of MedicineSeoulKorea;9. Department of UrologyCollege of MedicineInje UniversityPusanKorea;10. Department of UrologyChonbuk National University Medical SchoolJeonjuKorea;11. Department of UrologyCollege of MedicineHallym UniversitySeoulKorea;12. Department of UrologyChonnam National University Medical SchoolGwangjuKorea;1. Division of Adolescent MedicineIndiana University School of MedicineIndianapolisINUSA;2. Department of SociologyIndiana University Purdue University-IndianapolisIndianapolisINUSA;3. School of Public Health, Management, Policy & Community HealthUniversity of TexasHoustonTXUSA;4. Center for Sexual Health PromotionIndiana UniversityBloomingtonINUSA;5. The Kinsey Institute for Research on Sex, Gender and ReproductionIndiana UniversityBloomingtonINUSA;6. Department of Gender StudiesIndiana UniversityBloomingtonINUSA;1. Penile Curvature CenterSão PauloBrazil;2. London Andrology InstituteLondonUK;3. Washington Heights UrologyNew YorkNYUSA;1. Department of PsychologyValparaiso UniversityValparaisoINUSA;2. Department of Mathematics & StatisticsValparaiso UniversityValparaisoINUSA;1. Department of ObstetricsSão Paulo Federal University (UNIFESP)São PauloBrazil;2. Department of GynecologySão Paulo Federal University (UNIFESP)São PauloBrazil;3. Internal Medicine DepartmentSão Paulo Federal University (UNIFESP)São PauloBrazil;1. Department of Public HealthUniversity of CopenhagenCopenhagenDenmark;1. Department of PsychologyQueen''s UniversityKingstonONCanada;2. Department of UrologyQueen''s UniversityKingstonONCanada |
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| Abstract: | IntroductionThe method of administration of oral phosphodiesterase-5 inhibitors has been expanded to once-daily repeated administration with lower initial dosage than on-demand administration.AimThe aim of this study was to evaluate the efficacy and safety of once-daily udenafil as a treatment for erectile dysfunction (ED) for intermediate-term period.MethodsThis multicenter, randomized, double-blind clinical trial included 346 ED patients (placebo, udenafil 50 mg, udenafil 75 mg). Subjects were treated with each medication once daily for 24 weeks.Main Outcome MeasuresSubjects were asked to complete the International Index of Erectile Function (IIEF)-erectile function (EF) domain at baseline, 12 weeks, and 24 weeks and the development of adverse drug reactions (ADRs) was inspected.ResultsBoth dosages of udenafil induced a significant increase in IIEF-EF compared with placebo at both 12 and 24 weeks. When patients were divided according to the severity of baseline EF score, significant improvement was observed only with udenafil 75 mg regardless of the degree of ED. At 24 weeks, the proportions of patients who reported a return to normal EF (IIEF-EF over 26) were 39.1% for udenafil 50 mg and 47.0% for udenafil 75 mg. In terms of safety, ADRs were observed in 6.1%, 12.9%, and 17.9% for placebo, udenafil 50 mg, and 75 mg, respectively. Although a statistically higher rate of ADRs was observed in the udenafil 75 mg group (P = 0.024), the majority were mild and recovered without treatment.ConclusionsOnce-daily administration of udenafil 50 mg and 75 mg for 24 weeks resulted in improvement of EF. In particular, udenafil 75 mg improves EF regardless of the baseline degree of ED. Moon KH, Ko YH, Kim SW, Moon DG, Kim JJ, Park NC, Lee SW, Paick J-S, Ahn TY, Chung WS, Min KS, Park JK, Yang DY, and Park K. Efficacy of once-daily administration of udenafil for 24 weeks on erectile dysfunction: Results from a randomized multicenter placebo-controlled clinical trial. J Sex Med 2015;12:1194–1201. |
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