Efficacy of Udenafil for the Treatment of Erectile Dysfunction up to 12 Hours after Dosing: A Randomized Placebo-Controlled Trial |
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| Authors: | Hyun Jun Park Jong Kwan Park Kwangsung Park Kweonsik Min Nam Cheol Park |
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| Affiliation: | 2. Department of Urology, Chonbuk National University Medical School, Jeonju, Korea;3. Department of Urology, Chonnam National University Medical School, Gwangju, Korea;4. Department of Urology, Inje University College of Medicine, Busan, Korea;2. The James Buchanan Brady Urological Institute, The Johns Hopkins Hospital, Baltimore, MD, USA;3. Division of Urology, University of Western, ON, Canada;4. Sexology & STDs, Cairo University, Cairo, Egypt;5. Neuro-Urology-Andrology Unit, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France;6. Instituto H.Ellis, São Paulo, Brazil;7. Department of Urology, Section of Andrology and Male Infertility, Tulane University School of Medicine, New Orleans, LA, USA;8. Unidad Andrología, Servicio Urología Hospital, Regional Universitario Carlos Haya, Málaga, Spain;9. Department of Urology & Urological Reseach Institute (URI), Universiti Vita Saluta San Raffaele, Milan, Italy;10. University of California at San Francisco, San Francisco, CA, USA;2. University Biobank Limburg, Jessa Hospital, Hasselt, Belgium;3. Bayer HealthCare AG, Global Drug Discovery, Wuppertal, Germany;4. Department of Urology, Jessa Hospital, Hasselt, Belgium;1. Centre d''Etudes et de Traitement de la Pathologie de l''Appareil Reproducteur et de la Psychosomatique (CETPARP), Lille, France;2. Sexual Medicine & Andrology, University of Florence, Florence, Italy;3. Center For Sexual Function/Endocrinology, Lahey Clinic Northshore, Peabody, MA, USA;4. Clinica de Urologia e Andrologia, Belo-Horizonte, Minas-Gerais, Brazil |
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| Abstract: | IntroductionUdenafil is a newly developed selective phosphodiesterase type 5 inhibitor for the treatment of men with erectile dysfunction (ED).AimTo evaluate the efficacy of udenafil in treating ED for up to 12 hours after dosing.MethodsThis was a randomized, double-blind, placebo-controlled, parallel-group, fixed dose design, multicenter study. Following a 4-week nondrug baseline period, 104 men with ED of broad etiology and severity were randomized to one of two treatment groups: udenafil 100 mg or placebo. Participants were requested to attempt sexual intercourse at 12 hours after udenafil or placebo dosing during a 4-week treatment period.Main Outcome MeasuresThe primary efficacy variable was the response of patients to question 3 of the Sexual Encounter Profile (SEP Q3). The secondary efficacy measures were the response of patients to question 2 of the Sexual Encounter Profile (SEP Q2). Additional secondary efficacy measures included changes from baseline in the erectile function (EF) domain scores of the International Index of Erectile Function (IIEF) questionnaire.ResultsOf the 104 patients, 103 (50 in the udenafil group, 53 in the placebo group) completed the study. Udenafil significantly enhanced the rate of maintenance of erection (SEP Q3; placebo, 28.3% vs. udenafil, 54.7%; P < 0.0001). Significant change from baseline in the IIEF-EF domain was observed in the udenafil group (placebo, –0.58 ± 0.67; udenafil, 4.40 ± 0.84; P < 0.0001). For SEP Q2, there was no difference from baseline and no difference between the two groups. The overall adverse events rate was 11.3%. Most adverse events were mild or moderate in severity, and no serious adverse events were reported during the study and the follow-up period.ConclusionsUdenafil at 100 mg was effective for relieving ED for up to 12 hours after dosing. This duration of effectiveness could allow for flexibility and spontaneity in the sexual lives of patients. Park HJ, Park JK, Park K, Min K, and Park NC. Efficacy of udenafil for the treatment of erectile dysfunction up to 12 hours after dosing: A randomized placebo-controlled trial. |
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