A Randomized Open-Label Trial with a Crossover Comparison of Sexual Self-Confidence and Other Treatment Outcomes Following Tadalafil Once a Day Vs. Tadalafil or Sildenafil On-Demand in Men with Erectile Dysfunction

Journal of Sexual Medicine

Volumn 9, Issue 5, 2012, Pages 1418-1429

  Rubio Aurioles, Eusebio ^a   Porst, Hartmut ^b   Kim, Edward D ^c   Montorsi, Francesco ^d   Hackett, Geoff ^e   Morales, Antonio Martin ^f   Stuckey, Bronwyn ^g   Buttner, Hartwig ^h   West, Teena M ⁱ   Huynh, Ngan N ⁱ   Lenero, Enrique ^j   Burns, Patrick ^k   Kopernicky, Vladimir ^l  

^a Asociacion Mexicana para la Salud Sexual AC   (Mexico)

^b University of Tennessee ^*

^c UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE   (United States)

^d SAN RAFFAELE HOSPITAL   (Italy)

^e UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST   (United Kingdom)

^f Keogh Institute for Medical Research   (Spain)

^g Keogh Institute for Medical Research   (Australia)

^h LILLY DEUTSCHLAND GMBH   (Germany)

ⁱ ELI LILLY AUSTRALIA PTY LTD   (Australia)

^j Eli Lilly Korea Ltd   (South Korea)

^k Lilly USA   (United States)

^l ELI LILLY AND COMPANY   (United States)

more..

Author keywords

As needed; Erectile dysfunction; On demand; Once a day; Pharmacotherapy for erectile dysfunction; Sildenafil; Tadalafil

Indexed keywords

SILDENAFIL; TADALAFIL;

ADULT; ARTICLE; BACKACHE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSAGE SCHEDULE COMPARISON; DRUG INDUCED HEADACHE; DRUG SAFETY; DYSPEPSIA; ERECTILE DYSFUNCTION; FLUSHING; HUMAN; MAJOR CLINICAL STUDY; MALE; MYALGIA; NOSE CONGESTION; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SELF ESTEEM; SEXUAL BEHAVIOR; SIDE EFFECT; TREATMENT OUTCOME;

EID: 84860295435     PISSN: 17436095     EISSN: 17436109     Source Type: Journal    
DOI: 10.1111/j.1743-6109.2012.02667.x     Document Type: Article

References (23)

1. Eardley I, Donatucci C, Corbin J, El-Meliegy A, Hatzimouratidis K, McVary K, Munarriz R, Lee SW. Pharmacotherapy for erectile dysfunction. J Sex Med 2010;7:524-40.
2. Hatzimouratidis K, Hatzichristou DG. Phosphodiesterase type 5 inhibitors: Unmet needs. Curr Pharm Des 2009;15:3476-85.
3. Althof SE. When an erection alone is not enough: Biopsychosocial obstacles to lovemaking. Int J Impot Res 2002;14:S99-104.
4. Swindle RW, Cameron AE, Lockhart DC, Rosen RC. The psychological and interpersonal relationship scales: Assessing psychological and relationship outcomes associated with erectile dysfunction and its treatment. Arch Sex Behav 2004;33:19-30.
5. Dunn ME, Althof SE, Perelman MA. Phosphodiesterase type 5 inhibitors' extended duration of response as a variable in the treatment of erectile dysfunction. Int J Impot Res 2007;19:119-23.
6. Dean J, Hackett GI, Gentile V, Pirozzi-Farina F, Rosen RC, Zhao Y, Warner MR, Beardsworth A. Psychosocial outcomes and drug attributes affecting treatment choice in men receiving sildenafil citrate and tadalafil for the treatment of erectile dysfunction: Results of a multicenter, randomized, open-label, crossover study. J Sex Med 2006;3:650-61.
7. Donatucci CF, Wong DG, Giuliano F, Glina S, Dowsett SA, Watts S, Sorsaburu S. Efficacy and safety of tadalafil once daily: Considerations for the practical application of a daily dosing option. Curr Med Res Opin 2008;24:3383-92.
8. Montorsi F, Aversa A, Moncada I, Perimenis P, Porst H, Barker C, Shane MA, Sorsaburu S. A randomized, double-blind, placebo-controlled, parallel study to assess the efficacy and safety of once-a-day tadalafil in men with erectile dysfunction who are naïve to PDE5 inhibitors. J Sex Med 2011;8:2617-24.
9. Chow SC, Liu JP. Design and analysis of bioavailability and bioequivalence studies. 2nd revision edition. New York: Marcel Dekker; 2000:125-60.
10. Cappelleri JC, Althof SE, Siegel RL, Shpilsky A, Bell SS, Duttagupta S. Development and validation of the Self-Esteem and Relationship (SEAR) questionnaire in erectile dysfunction. Int J Impot Res 2004;16:30-8.
11. 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.
12. Althof SE, Corty EW, Levine SB, Levine F, Burnett AL, McVary K, Stecher V, Seftel AD. EDITS: Development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology 1999;53:793-9.
13. Senn S. Cross-over trials in clinical research. 2nd edition. Chichester, UK: John Wiley & Sons Inc.; 2002:364 pages.
14. Berner MM, Kriston L, Harms A. Efficacy of PDE-5-inhibitors for erectile dysfunction. A comparative meta-analysis of fixed-dose regimen randomized controlled trials administering the International Index of Erectile Function in broad-spectrum populations. Int J Impot Res 2006;18:229-35.
15. Eardley I, Mirone V, Montorsi F, Ralph D, Kell P, Warner MR, Zhao Y, Beardsworth A. An open-label, multicentre, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in men naive to phosphodiesterase 5 inhibitor therapy. BJU Int 2005;96:1323-32.
16. Kim SC. Regaining of morning erection and sexual confidence in patients with erectile dysfunction. Asian J Androl 2006;8:703-8.
17. Son H, Park K, Kim SW, Paick JS. Reasons for discontinuation of sildenafil citrate after successful restoration of erectile function. Asian J Androl 2004;6:117-20.
18. Brock G, Chan J, Carrier S, Chan M, Salgado L, Klein AH, Lang C, Horner R, Gutkin S, Dickson R. The treatment of erectile dysfunction study: Focus on treatment satisfaction of patients and partners. BJU Int 2007;99:376-82.
19. Giannitsas K, Konstantinopoulos A, Patsialas C, Perimenis P. Preference for and adherence to oral phosphodiesterase-5 inhibitors in the treatment of erectile dysfunction. Patient Prefer Adherence 2008;2:149-55.
20. Porst H, Giuliano F, Glina S, Ralph D, Casabe AR, Elion-Mboussa A, Shen W, Whitaker JS. Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5mg and 10mg in the treatment of erectile dysfunction: Results of a multicenter, randomized, double-blind, placebo-controlled trial. Eur Urol 2006;50:351-9.
21. Rubio-Aurioles E, Kim ED, Rosen RC, Porst H, Burns P, Zeigler H, Wong DG. Impact on erectile function and sexual quality of life of couples: A double-blind, randomized, placebo-controlled trial of tadalafil taken once daily. J Sex Med 2009;6:1314-23.
22. El Khiat Y, Ghazi S, Allam A, Khawaja M, Belger M, Tamer M, Kopernicky V. Psychosocial impact and effectiveness of tadalafil among treatment-naive and previously-treated men with erectile dysfunction in Saudi Arabia and other Gulf-region countries. Curr Med Res Opin 2008;24:1965-73.
23. Smith CG. Drug effects on male sexual function. Clin Obstet Gynecol 1982;25:525-31.