Long-term, multicenter study of the safety and efficacy of topical alprostadil cream in male patients with erectile dysfunction

Journal of Sexual Medicine

Volumn 6, Issue 2, 2009, Pages 520-534

  Rooney, Michael ^a   Pfister, William ^b   Mahoney, Mary ^b   Nelson, Melissa ^a   Yeager, James ^c   Steidle, Christopher ^d  

^a RADIANT RESEARCH   (United States)

^b NexMed USA Inc   (United States)

^c JL Yeager and Associates Inc   (United States)

^d NorthEast Indiana Research LLC   (United States)

Author keywords

Alprostadil; Erectile dysfunction; Long term safety and efficacy; MUSE; PDE 5 inhibitor; Topical alprostadil

Indexed keywords

PROSTAGLANDIN E1;

ABNORMAL LABORATORY RESULT; APPLICATION SITE BURNING; APPLICATION SITE ERYTHEMA; ARTICLE; BACKACHE; CLINICAL TRIAL; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ELECTROCARDIOGRAPHY; ERECTILE DYSFUNCTION; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PENIS DISEASE; PHYSICAL EXAMINATION; PRIAPISM; PRIORITY JOURNAL; PROSTATE DISEASE; RHINITIS; SIDE EFFECT; TENDON DISEASE; URINARY TRACT INFECTION; VITAL SIGN;

EID: 59349114481     PISSN: 17436095     EISSN: 17436109     Source Type: Journal    
DOI: 10.1111/j.1743-6109.2008.01118.x     Document Type: Article

References (34)

1. Utiger RD. A pill for impotence. N Engl J Med 1998;338:1458-9.
2. Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med 1998;338:1397-404.
3. Brock GB, McMahon CG, Chen KK, Costigan T, Shen W, Watkins V, Anglin G, Whitaker S. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: Results of integrated analyses. J Urol 2002;168:1332-6.
4. Hellstrom WJ, Gittelman M, Karlin G, Segerson T, Thibonnier M, Taylor T, Padma-Nathan H. Vardenafil for treatment of men with erectile dysfunction: Efficacy and safety in a randomized, double-blind, placebo-controlled trial. J Androl 2002;23:763-71.
5. Pryor JL, Redmon B. New therapies and delivery mechanisms for treatment of erectile dysfunction. Int J Impot Res 2000;12:S158-62.
6. Rosen RC, Fisher WA, Eardley I, Niedergberger C, Nadel A, Sand M; Men's Attitudes to Life Events and Sexuality (MALES) Study. The multinational Men's Attitudes to Life Events and Sexuality (MALES) study: I. Prevalence of erectile dysfunction and related health concerns in the general population. Curr Med Res Opin 2004;20:607-17.
7. de Tejada IS. Therapeutic strategies for optimizing PDE-5 inhibitor therapy in patients with erectile dysfunction considered difficult or challenging to treat. Int J Impot Res 2004;16:S40-2.
8. Lau DH, Kommu S, Mumtaz FH, Morgan RJ, Thompson CS, Mikhailidis DP. The management of phosphodiesterase-5 (PDE5) inhibitor failure. Curr Vasc Pharmacol 2006;4:89-93.
9. Lüke M, Szurman P, Schneider T, Lüke C. The effects of the phosphodiesterase type V inhibitor sildenafil on human and bovine retinal function in vitro. Graefes Arch Clin Exp Ophthalmol 2007;245:1211-5.
10. Makhlouf A, Kshirsagar A, Niederberger C. Phosphodiesterase 11: A brief review of structure, expression and function. Int J Impot Res 2006;18:501-9.
11. Gresser U, Gleiter CH. Erectile dysfunction: Comparison of efficacy and side effects of the PDE-5 inhibitors sildenafil, vardenafil and tadalafil-Review of the literature. Eur J Med Res 2002;7:435-46.
12. Campbell HE. Clinical monograph for drug formulary review: Erectile dysfunction agents. J Manag Care Pharm 2005;11:151-71.
13. American Urological Association (AUA). Management of erectile dysfunction. Education and Research Inc., Website. 2005. Available at: http://www.auanet.org/guidelines-and-quality-care/ clinical-guidelines.cfm?sub=ed (accessed 10 January, 2008).
14. Jackson G, Rosen RC, Kloner RA, Kostis JB. The second Princeton consensus on sexual dysfunction and cardiac risk: New guidelines for sexual medicine. J Sex Med 2006;3:28-36.
15. Melnik T, Soares BG, Nasello AG. The effectiveness of psychological interventions for the treatment of erectile dysfunction: Systematic review and meta-analysis, including comparisons to sildenafil treatment, intracavernosal injection, and vacuum devices. J Sex Med 2008;5:2562-74.
16. Giuliano F, Amar E, Chevallier D, Montaigne O, Joubert JM, Chartier-Kastler E. How urologists manage erectile dysfunction after radical prostatectomy: A national survey (REPAIR) by the French urological association. J Sex Med 2008;5:448-57.
17. Linet OI, Ogrinc FG. Efficacy and safety of intracavernosal alprostadil in men with erectile dysfunction. The Alprostadil Study Group. N Engl J Med 1996;334:873-7.
18. Williams G, Abbou CC, Amar ET, Desvaux P, Flam TA, Lycklama à Nijeholt GA, Lynch SF, Morgan RJ, Müller SC, Porst H, Pryor JP, Ryan P, Witzsch UK, Hall MM, Place VA, Spivack AP, Gesundheit N. Efficacy and safety of transurethral alprostadil therapy in men with erectile dysfunction. MUSE Study Group. Br J Urol 1998;81:889-94.
19. Buyuktimkin N, Buyuktimkin S, Rytting JH. Chemical means of transdermal drug permeation enhancement. In: Ghosh TK, Pfister WR, Yum SI, eds. Transdermal and topical drug delivery systems. Englewood, CO: Interpharm Press; 1997:357-475.
20. Padma-Nathan H, Yeager JL. An integrated analysis of alprostadil topical cream for the treatment of erectile dysfunction in 1732 patients. Urology 2006;68:386-91.
21. Becher E. Topical alprostadil cream for the treatment of erectile dysfunction. Expert Opin Pharmacother 2004;5:623-32.
22. Yeager J, Beihn R. Retention and migration of alprostadil cream applied topically to the glans meatus for erectile dysfunction. Int J Impot Res 2005;17:91-5.
23. 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.
24. Rosen RC, Cappelleri JC, Gendrano N III. The international index of erectile function (IIEF): A state-of-the-science review. Int J Impot Res 2002;14:226-44.
25. DeRogatis LR. Assessment of sexual function/dysfunction via patient reported outcomes. Int J Impot Res 2008;20:35-44.
26. Hellstrom WJG. Current safety and tolerability issues in men with erectile dysfunction receiving PDE5 inhibitors. Int J Clin Pract 2007;61:1547-54.
27. Heiman JR, Gittelman M, Costabile R, Guay A, Friedman A, Heard-Davison A, Peterson C, Dietrich J, Stephens D. Topical alprostadil (PGE1) for the treatment of female sexual arousal disorder: In-clinic evaluation of safety and efficacy. J Psychosom Obstet Gynaecol 2006;27:31-41.
28. Kielbasa LA, Daniel KL. Topical alprostadil treatment for female sexual arousal disorder. Ann Pharmacother 2006;40:1369-76.
29. Islam A, Mitchel J, Rosen R, Phillips N, Ayers C, Ferguson D, Yeager J. Topical alprostadil in the treatment of female sexual arousal disorder: A pilot study. J Sex Marital Ther 2001;27:531-40.
30. Padma-Nathan H, Brown C, Fendl J, Salem S, Yeager J, Harning R. Efficacy and safety of topical alprostadil cream for the treatment of female sexual arousal disorder (FSAD): A double-blind, multi-center, randomized, and placebo-controlled clinical trial. J Sex Marital Ther 2003;29:329-44.
31. Liao Q, Zhang M, Geng L, Wang X, Song X, Xia P, Lu T, Lu M, Liu V. Efficacy and safety of alprostadil cream for the treatment of female sexual arousal disorder: A double-blind, placebo-controlled study in Chinese population. J Sex Med 2008;5:1923-31.
32. ICH Harmonized Tripartite Guideline. E1: The extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening conditions. 1995. Available at: http://www.ich.org/LOB/media/MEDIA435.pdf (accessed July 31, 2006).
33. Alexandre B, Lemaire A, Desvaux P, Amar E. Intracavernous injections of prostaglandin E1 for erectile dysfunction: Patient satisfaction and quality of sex life on long-term treatment. J Sex Med 2007;4:426-31.
34. Marks LS, Duda C, Dorey FJ, Macairan ML, Santos PB. Treatment of erectile dysfunction with sildenafil. Urology 1999;53:19-24.