Efficacy of udenafil for the treatment of erectile dysfunction up to 12 hours after dosing: A randomized placebo-controlled trial

Journal of Sexual Medicine

Volumn 7, Issue 6, 2010, Pages 2209-2216

  Park, Hyun Jun ^a   Park, Jong Kwan ^b   Park, Kwangsung ^c   Min, Kweonsik ^d   Park, Nam Cheol ^a  

^a Pusan National University School of Medicine   (South Korea)

^b Chonbuk National University Medical School   (South Korea)

^c Chonnam National University Medical School   (South Korea)

^d Inje University College of Medicine   (South Korea)

Author keywords

Clinical Trial; Erectile Dysfunction; Long Acting PDE5 Inhibitor; PDE5; Udenafil

Indexed keywords

PLACEBO; UDENAFIL;

ADULT; AGED; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; ERECTILE DYSFUNCTION; FLUSHING; FOLLOW UP; HEADACHE; HUMAN; INTERNATIONAL INDEX OF ERECTILE FUNCTION; MALE; MULTICENTER STUDY; NOSE CONGESTION; PARALLEL DESIGN; PENIS ERECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SEXUAL BEHAVIOR; SEXUAL INTERCOURSE; SIDE EFFECT; STATISTICAL ANALYSIS; STOMACH DISCOMFORT; TOOTH PAIN; TREATMENT DURATION;

EID: 77953947123     PISSN: 17436095     EISSN: 17436109     Source Type: Journal    
DOI: 10.1111/j.1743-6109.2010.01817.x     Document Type: Article

References (27)

1. Kuan J, Brock G. Selective phosphodiesterase type 5 inhibition using tadalafil for the treatment of erectile dysfunction. Expert Opin Investig Drugs 2002, 11:1605-13.
2. Carson CC, Lue TF. Phosphodiesterase type 5 inhibitors for erectile dysfunction. BJU Int 2005, 96:257-80.
3. Paick JS, Kim SW, Yang DY, Kim JJ, Lee SW, Ahn TY, Choi HK, Suh JK, Kim SC. The efficacy and safety of udenafil, a new selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction. J Sex Med 2008, 5:946-53.
4. Paick JS, Ahn TY, Choi HK, Chung WS, Kim JJ, Kim SC, Kim SW, Lee SW, Min KS, Moon KH, Park JK, Park K, Park NC, Suh JK, Yang DY, Jung HG. Efficacy and safety of mirodenafil, a new oral phosphodiesterase type 5 inhibitor, for treatment of erectile dysfunction. J Sex Med 2008, 5:2672-80.
5. Mirone V, Fusco F, Rossi A, Sicuteri R, Montorsi F. Tadalafil and vardenafil vs sildenafil: A review of patient-preference studies. BJU Int 2009, 103:1212-7.
6. Shindel AW. 2009 update on phosphodiesterase type 5 inhibitor therapy part 1: Recent studies on routine dosing for penile rehabilitation, lower urinary tract symptoms, and other indications (CME). J Sex Med 2009, 6:1794-808.
7. Hatzichristou D, Vardi Y, Papp G, Pushkar D, Basson BR, Kopernicky V. Effect of tadalafil on sexual timing behavior patterns in men with erectile dysfunction: Integrated analysis of randomized, placebo controlled trials. J Urol 2005, 174:1356-9.
8. Doh H, Shin CY, Son M, Ko JI, Yoo M, Kim SH, Kim WB. Mechanism of erectogenic effect of the selective phosphodiesterase type 5 inhibitor, DA-8159. Arch Pharm Res 2002, 25:873-8.
9. Salem EA, Kendirci M, Hellstrom WJ. Udenafil, a long-acting PDE5 inhibitor for erectile dysfunction. Curr Opin Investig Drugs 2006, 7:661-9.
10. Kim BH, Lim HS, Chung JY, Kim JR, Lim KS, Sohn DR, Cho JY, Yu KS, Shin SG, Paick JS, Jang IJ. Safety, tolerability and pharmacokinetics of udenafil, a novel PDE-5 inhibitor, in healthy young Korean subjects. Br J Clin Pharmacol 2008, 65:848-54.
11. Cappelleri JC, Rosen RC, Smith MD, Mishra A, Osterloh IH. Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function. Urology 1999, 54:346-51.
12. Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): A multidimensional scale for assessment of erectile dysfunction. Urology 1997, 49:822-30.
13. Rosen RC, Cappelleri JC, Gendrano N. The International Index of Erectile Function (IIEF): A state-of-the-science review. Int J Impot Res 2002, 14:226-44.
14. Mulhall JP, Montorsi F. Evaluating preference trials of oral phosphodiesterase 5 inhibitors for erectile dysfunction. Eur Urol 2006, 49:30-7.
15. Lee J, Pommerville P, Brock G, Gagnon R, Mehta P, Krisdaphongs M, Chan M, Chan J, Dickson R. Physician-rated patient preference and patient- and partner-rated preference for tadalafil or sildenafil citrate: Results from the Canadian 'Treatment of Erectile Dysfunction' observational study. BJU Int 2006, 98:623-9.
16. Tolrà JR, Campaña JM, Ciutat LF, Miranda EF. Prospective, randomized, open-label, fixed-dose, crossover study to establish preference of patients with erectile dysfunction after taking the three PDE-5 inhibitors. J Sex Med 2006, 3:901-9.
17. Fugl-Meyer A, Althof S, Buvat J, Paget MA, Sotomayor M, Stothard D. Aspects of sexual satisfaction in men with erectile dysfunction: A factor analytic and logistic regression approach. J Sex Med 2009, 6:232-42.
18. Conaglen HM, Conaglen JV. Investigating women's preference for sildenafil or tadalafil use by their partners with erectile dysfunction: The partners' preference study. J Sex Med 2008, 5:1198-207.
19. Rubio-Aurioles E, Glina S, Abdo CH, Hernandez-Serrano R, Rampazzo C, Sotomayor M, West TM, Gallagher GL, Lenero E. Timing of dose relative to sexual intercourse attempt in previous sildenafil citrate users treated with tadalafil: A geographical comparison from a single arm, open-label study. J Sex Med 2009, 6:2836-50.
20. Glina S, Sotomayor M, Gatchalian E, Yaman O, Dyachkova Y, Markey C, Kopernicky V. Timing of dose relative to sexual intercourse attempt in previous sildenafil citrate users treated with tadalafil. J Sex Med 2006, 3:309-19.
21. Giuliano F, Vicaut E, Jeanpetit Y. Impact of the pharmacokinetic properties of PDE5 inhibitors on the dose/sexual intercourse interval. Prog Urol 2008, 18:536-42.
22. Eardley I, Ellis P, Boolell M, Wulff M. Onset and duration of action of sildenafil for the treatment of erectile dysfunction. Br J Clin Pharmacol 2002, 53(1):61S-5S. suppl
23. Zinner N. Do food and dose timing affect the efficacy of sildenafil? A randomized placebo-controlled study. J Sex Med 2007, 4:137-44.
24. Gingell C, Sultana SR, Wulff MB, Gepi-Attee S. Duration of action of sildenafil citrate in men with erectile dysfunction. J Sex Med 2004, 1:179-84.
25. Pickering TG, Shepherd AM, Puddey I, Glasser DB, Orazem J, Sherman N, Mancia G. Sildenafil citrate for erectile dysfunction in men receiving multiple antihypertensive agents: A randomized controlled trial. Am J Hypertens 2004, 17:1135-42.
26. Moncada I, Jara J, Subirá D, Castaño I, Hernández C. Efficacy of sildenafil citrate at 12 hours after dosing: Re-exploring the therapeutic window. Eur Urol 2004, 46:357-60.
27. Francis SH, Morris GZ, Corbin JD. Molecular mechanisms that could contribute to prolonged effectiveness of PDE5 inhibitors to improve erectile function. Int J Impot Res 2008, 20:333-42.