List of references for each unique study
Sildenafil versus placebo
Study ID References
Crossover trials (fixed)
Webster LJ, Michelakis ED, Davis T, Archer SL: Use of sildenafil for safe improvement of erectile function and quality of life in men with New York Heart
SIL1b
Association classes II and III congestive heart failure: a prospective, placebo-controlled, double-blind crossover trial.[see comment]. Arch Intern Med 2004;
164(5):514-520.
Parallel groups (PG) trials fixed dose
Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA: Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group.[see
SIL11
comment][erratum appears in N Engl J Med 1998 Jul 2;339(1):59]. N Engl J Med 1998; 338(20):1397-1404. (dose-response study)
Goldstein I, Lue TF, Padma NH, Rosen RC, Steers WD, Wicker PA, Corporate author: Sildenafil Study G: Oral sildenafil in the treatment of erectile dysfunction
(Reprinted with permission from N Engl J Med, vol 338, pg 1397-1404, 1998). J Urol 2002; 167(2):1197-1203.
Padma-Nathan H: A 24-week fixed-dose study to assess the efficacy and safety of sildenafil (Viagra) in men with erectile dysfunction. J-Urol 1998; 159(5,
Suppl. (abstract 911)):238.
Padma-Nathan H: Oral sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction: assessment of erections hard enough for sexual intercourse. Int J
Clin Pract 1999; Supplement. 102:13-15.
SIL12
Derry F, Glass C, Dinsmore WW, Fraser M, Gardner BP, Maytom M, Orr M, Osterloh I, Smith MD: Sildenafil (Viagra(TM)): An oral treatment for men with
erectile dysfunction caused by traumatic spinal cord injury - A 28-day, double blind, placebo controlled, parallel-group, dose-response study. Neurology 1997;
48(S2 abstract S28.005):A215.
Derry FA, Dinsmore WW, Fraser M, Gardner BP, Glass CA, Maytom MC, Smith MD: Efficacy and safety of oral sildenafil (Viagra) in men with erectile
dysfunction caused by spinal cord injury. Neurology 1998; 51(6):1629-1633.
Maytom MC, Derry FA, Dinsmore WW, Glass CA, Smith MD, Orr M, Osterloh IH: A two-part pilot study of sildenafil (VIAGRA) in men with erectile
dysfunction caused by spinal cord injury. Spinal Cord 1999; 37(2):110-116.
SIL13
Montorsi F, McDermott TE, Morgan R, Olsson A, Schultz A, Kirkeby HJ, Osterloh IH: Efficacy and safety of fixed-dose oral sildenafil in the treatment of
erectile dysfunction of various etiologies.[see comment]. Urology 1999; 53(5):1011-1018.
SIL14
Dinsmore WW, Gingell CJC, Jardin A, et al. Sildenafil (Viagra), a new oral treatment for erectile dysfunction (ED): a double-blind, placebo-controlled parallel
group once daily dose-response study. International Journal of Impotence Research 8[abstract D100], 147. 1996.
Gingell CJC, Jardin A, Olsson AM, Dinsmore WW, Osterloh IH, Kirkpatrick J, Cuddigan M: UK-92,480, a new oral treatment for erectile dysfunction: a
double- blind, placebo-controlled, once daily dose response study. J-Urol 1996; 155(5, Suppl.):495A.
Olsson AM, Abramsson L, Grenabo L, Gustafsson H, Hedelin H, Kihl B, Malmberg L, Oldbring J, Pedersen J, Persson BE, Gingell C, Jardin A, Dinsmore W,
Osterloh I, Kirkpatrick J, Cuddigan M: Peroral treatment of erectile dysfunction with sildenafil (Viagra) (UK-92,480). A double-blind, placebo-controlled,
international multicentre study. Scand-J-Urol-Nephrol 1996; 30(Suppl. 181 abstract 6):9.
Olsson AM, Speakman MJ, Dinsmore WW, Giuliano F, Gingell C, Maytom M, Smith MD, Osterloh I, Sildenafil Multicentre Study Group.: Sildenafil citrate
(Viagra) is effective and well tolerated for treating erectile dysfunction of psychogenic or mixed aetiology. Int J Clin Pract 2000; 54(9):561-566.
Pfizer. Study 148-353: A randomised, double-blind, placebo controlled, parallel-group, multicentre, dose-response study to assess the efficacy and safety of
sildenafil (UK-92,480) administrered once daily for 28 days to patients with erectile dysfunction. FDA website 1998.
SIL15
Seibel I, Poli De Figueiredo CE, Teloken C, Moraes JF: Efficacy of oral sildenafil in hemodialysis patients with erectile dysfunction. J Am Soc Nephrol 2002;
13(11):2770-2775.
SIL16
Padma-Nathan H, Gasser DB, Stecher VJ, Orazem J, Tseng LJ, DeRiesthal H: Minimum time to onset of erection after Viagra (sildenafil citrate): results of a
randomized, double-blind, placebo-controlled trial. Int J Impot Res 2002; 14(Suppl 4):S15.
Padma-Nathan H, Stecher VJ, Sweeney M, Orazem J, Tseng LJ, DeRiesthal H: Minimal time to successful intercourse after sildenafil citrate: results of a
randomized, double-blind, placebo-controlled trial. Urology 2003; 62(3):400-403.
SIL17
Safarinejad MR: Oral sildenafil in the treatment of erectile dysfunction in diabetic men: a randomized double-blind and placebo-controlled study. J Diabetes
Complications 2004; 18(4):205-210.
SIL18
Pfizer. Study 148-106: A double-blind, randomised, placebo-controlled, parallel group, multicentre, fixed-dose study to assess the efficacy and safety of
sildenafil administrered as required to male subjects with erectile dysfunction. FDA website 1998.
SIL19
Pfizer. Study 148-361: A 12-week, double-blind, placebo controlled, parallel group, multi-centre study followed by a 40 week open label extension to evaluate
the efficacy and safety of UK-92,480 (sildenafil) in patients with erectile dysfunction. FDA website 1998.
SIL20
Lue TF: A study of sildenafil (Viagra), a new oral agent for the treatment of male erectile dysfunction. J Urol 1997; 157(4, Suppl. abstract 701):181.
Lue TF, Sildenafil Study Group. Sildenafil (Viagra) is effective in the treatment of severe male erectile dysfunction(abstract). Int J Impot Res 9[Suppl 1 (abstract
A58)], S46. 1997.
Lue TF, Sildenafil Study Group. Long-term efficacy and safety of sildenafil (Viagra): a 6-month, randomized, double-blind, placebo-controlled study in men
with erectile dysfunction (ED)(abstract). Int J Impot Res 9[Suppl 1 (abstract A57)], S46. 1997.
Pfizer. 148-101/101B: A randomised, double-blind, placebo controlled, parallel-group, fixed-dose, multicentre, long-term dose-response study to assess the
efficacy and safety of sildenafil (UK-92, 480) administered prior to sexual activity to male patients with erectile dysfunction. FDA website 1998.
SIL21
Pfizer. Protocol A1481146: A multicenter, double-blind study to evaluate the effect of pre-treatment with a daily dose of viagra (sildenafil citrate) on the PRN
efficacy of viagra in men with erectile dysfunction and type 2 Diabetes. 2005. (www.clinicalstudiesresults.org)
SIL22
Cavallini G, Modenini F, Vitali G, Koverech A: Acetyl-L-carnitine plus propionyl-L-carnitine improve efficacy of sildenafil in treatment of erectile dysfunction
after bilateral nerve-sparing radical retropubic prostatectomy. Urology 2005; 66(5):1080-1085.
SIL23
Mancini M, Raina R, Agarwal A, Nerva F, Colpi GM: Sildenafil citrate vs intracavernous alprostadil for patients with arteriogenic erectile dysfunction: a
randomised placebo controlled study. Int J Impot Res 2004; 16(1):8-12.
SIL25
Shirai M, Tsukamoto T, Sato Y, Horita H, Kato S, Yachiku S, Kaneko S, Mizunaga M, Taniguchi N, Fujioka T, Banya Y, Okada K, Nagashima H, Iwahori T,
Takimoto Y, Hirakata H, Abe T, Murai M, Marumo K, Iwamoto Y, Takahashi Y, Takasaka S, Kai Y, Onodera Y, Sasaki H, Ishii N, Nagao K, Fukui J, Nagata
M, Nukui F, Ishido T, Iwamoto T, Yajima M, Fuse H, Nagakawa O, Mizuno I, Namiki M, Uchibayashi T, Koshida K, Otani T: Randomized, placebo-controlled,
double-blind study of oral sildenafil in Japanese men with erectile dysfunction. Nishinihon Journal of Urology 2000; 62(6):373-382.
BAYER2003 Trial 10128 (A randomized, double-blind placebo-and active (Viagra) controlled multicenter, fixed-dose parallel group 3-month comparison study
to investigate the efficacy and safety of the phosphodiesterase type V inhibitor BAY 38-9456 in men with erectile dysfunction. FDA website 2003.
PG trials-flexible dose – North America
Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA: Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group.[see
SIL31
comment][erratum appears in N Engl J Med 1998 Jul 2;339(1):59]. N Engl J Med 1998; 338(20):1397-1404. (dose-escalation study)
SIL26
Goldstein I, Lue TF, Padma NH, Rosen RC, Steers WD, Wicker PA, Corporate author: Sildenafil Study G: Oral sildenafil in the treatment of erectile dysfunction
(Reprinted with permission from N Engl J Med, vol 338, pg 1397-1404, 1998). J Urol 2002; 167(2):1197-1203.
Feldman R, Meuleman EJ, Steers W: Sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction: analysis of two flexible dose-escalation studies.
Sildenafil Study Group. Int J Clin Pract 1999; Supplement. 102:10-12.
Hultling C, Hultling C: Partners' perceptions of the efficacy of sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction. Int J Clin Pract 1999;
Supplement. 102:16-18.
Padma-Nathan H, Steers WD, Wicker PA: Efficacy and safety of oral sildenafil in the treatment of erectile dysfunction: a double-blind, placebo-controlled study
of 329 patients. Sildenafil Study Group.[see comment]. Int J Clin Pract 1998; 52(6):375-379.
Shabsigh R: Efficacy of sildenafil citrate (VIAGRA) is not affected by aetiology of erectile dysfunction. Int J Clin Pract 1999; Supplement. 102:19-20.
Wicker P: Effect of Oral Sildenafil on Intercourse Success in Patients with Erectile Dysfunction of Broad-Spectrum Etiology. 151st Annual Meeting of the
American Psychiatric Association; Toronto, Ontario, Canada. 30th May-4th June. Issue NR304, 1998.
Young J: Sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction: a 12-week, flexible-dose study to assess efficacy and safety. Int J Clin Pract 1999;
Supplement. 102:6-7.
SIL33
Asscheman H: Sildenafil (Viagra) for the treatment of erectile dysfunction in men with diabetes mellitus. (Dutch). Ned-Tijdschr-Geneeskd 1999; 143(27):14401441.
Herschorn S: Sildenafil improved erections and increased successful sexual intercourse in diabetic men with erectile dysfunction. ACP Journal Club 1999;
v131:3-Aug.
Rendell MS: Sildenafil (Viagra) improves intercourse success in patients with erectile dysfunction and diabetes. Diabetologia 1998; 41(Suppl. 1 (abstract
1193)):A308.
Rendell MS, Moreno F: A double-blind, placebo-controlled, flexible dose-escalation study assessing the efficacy and safety of sildenafil (VIAGRA(TM)) in men
with erectile dysfunction and diabetes. Diabetes 1998; 47(S1 (abstract 33)):A9.
Rendell MS, Rajfer J, Wicker PA, Smith MD: Sildenafil for treatment of erectile dysfunction in men with diabetes: a randomized controlled trial. Sildenafil
Diabetes Study Group.[see comment]. JAMA 1999; 281(5):421-426.
SIL38
Cappelleri JC, Siegel RL, Osterloh IH, Rosen RC: Relationship between patient self-assessment of erectile function and the erectile function domain of the
international index of erectile function. Urology 2000; 56(3):477-481.
Cappelleri JC, Siegel RL, Glasser DB, Osterloh IH, Rosen RC: Relationship between patient self-assessment of erectile dysfunction and the sexual health
inventory for men. Clin Ther 2001; 23(10):1707-1719.
Lewis R, Bennett CJ, Borkon WD, Boykin WH, Althof SE, Stecher VJ, Siegel RL: Patient and partner satisfaction with Viagra (sildenafil citrate) treatment as
determined by the Erectile Dysfunction Inventory of Treatment Satisfaction Questionnaire. Urology 2001; 57(5):960-965.
SIL39
Seidman SN, Rosen R, Menza MA. Effect of sildenafil citrate in men with erectile dysfunction and depression. 53rd Institute on Psychiatric Services October 10-
14 Orlando Florida. 2001.
Seidman SN, Roose SP, Menza MA, Shabsigh R, Rosen RC: Treatment of erectile dysfunction in men with depressive symptoms: results of a placebo-controlled
trial with sildenafil citrate.[see comment]. Am J Psychiatry 2001; 158(10):1623-1630.
Wilson SA: Sildenafil improved erectile dysfunction and quality of life in men with comorbid mild-to-moderate depression. ACP Journal Club 2002; 137(1):21.
SIL41a
Study 1
Hilliard GK, Raval P, Ferdinand KC: A randomized controlled trial to evaluate the efficacy and safety of sildenafil citrate in black Americans with erectile
dysfunction. J Urol 2002; 167(SS abstract 1110):282.
SIL41b
Study 2
Young JM, Bennett C, Gilhooly P, Wessells H, Ramos DE: Efficacy and safety of sildenafil citrate (Viagra) in black and Hispanic American men. Urology 2002;
60(2 Suppl 2):39-48.
Young JM, Bennett C, Gilhooly P, Wessells H, Ramos DE: Efficacy and safety of sildenafil citrate (Viagra) in black and Hispanic American men. Urology 2002;
60(2 Suppl 2):39-48.
SIL45
Nurnberg HG, Gelenberg AJ, Fava M, Hensley PL, Lauriello J, Harrison WM, Siegel RL. Sildenafil for SRI-associated sexual dysfunction: a three-center, sixweek, double-blind, placebo-controlled study in 90 men. Annual Meeting New Research Program and Abstracts American Psychiatric Association [Washington],
241. 2002.
Nurnberg HG, Hensley PL, Gelenberg AJ, Fava M, Lauriello J, Paine S: Treatment of antidepressant-associated sexual dysfunction with sildenafil: a randomized
controlled trial.[see comment]. JAMA 2003; 289(1):56-64.
Nurnberg HG, Hensley PL, Paine S: Discriminating treatment effects of sildenafil on orgasm delay and erectile dysfunction in serotonergic antidepressantassociated sexual dysfunction. J-Urol 2003; 169(4, Suppl.):376.
Nurnberg HG, Hensley PL, Paine S, Slonimski C. Effects of sildenafil citrate on ejaculatory delay and erectile dysfunction. American Psychiatric Association
Annual Meeting . 2004.
SIL51
DeBusk RF, Pepine CJ, Glasser DB, Shpilsky A, DeRiesthal H, Sweeney M: Efficacy and safety of sildenafil citrate in men with erectile dysfunction and stable
coronary artery disease.[erratum appears in Am J Cardiol. 2004 Aug 15;94(4):543-4]. Am J Cardiol 2004; 93(2):147-153.
SIL57
Katz SD, Parker JD, Glasser DB, Bank AJ, Sherman N, Wang H, Sweeney M: Efficacy and safety of sildenafil citrate in men with erectile dysfunction and
chronic heart failure. Am J Cardiol 2005; 95(1):36-42.
SIL58
Althof SE, Cappelleri J: U.S. Double-Blind, Placebo-Controlled Trial Assessing Self-Esteem, Confidence, and Relationships in Men With Erectile Dysfunction
Treated With Sildenafil Citrate. 157th Annual Meeting of the American Psychiatric Association; 2004; 2004 May 1-6; New York, NY NR231p. 2004.
Cappelleri J, O'Leary MP, Althof SE, Duttagupta S, Sherman N, Crowley AR, Siegel R, Tseng LJ, Glasser DB: Responsiveness of the Self-Esteem And
Relationship questionnaire in men with erectile dysfunction treated with Viagra(R) (sildenafil citrate): Results from an international, double-blind, placebocontrolled Trial. Pharmacoepidemiology and Drug Safety 2004; 13(abstract 435):S218.
Cappelleri JC, Duttagupta S, Sherman N, Siegel RL, Crowley A, Tseng L, O'Leary M, Althof SE. Self-esteem, confidence and relationships in men with erectile
dysfunction treated with sildenafil citrate. J Gen Intern Med 19[suppl 1], 209. 2004.
O'Leary MP, Althof SE, Cappelleri JC, Crowley A, Sherman N, Duttagupta S, The United States Self-Esteem and Relationship Questionnaire Study Group.:
Self-esteem, confidence and relationship satisfaction of men with erectile dysfunction treated with sildenafil citrate: a multicenter, randomized, parallel group,
double-blind, placebo controlled study in the United States. J Urol 2006; 175(3 Pt 1):1058-1062.
Pfizer. Protocol A1481118: A multicenter, randomized, parallel-group, double-blind placebo controlled, flexible dose escalation study to evaluate self-esteem
and overall relationships in men with erectile dysfunction treated with Viagra (sildenafil citrate) in the Unites States. 2003. (www.clinicaltrials-results.org)
PG trials-flexible dose – South America
Becher E, Tejada NA, Gomez R, Decia R, Southern Latin America Sildenafil Study Group: Sildenafil citrate (Viagra) in the treatment of men with erectile
SIL40
dysfunction in southern Latin America: a double-blind, randomized, placebo-controlled, parallel-group, multicenter, flexible-dose escalation study. Int J Impot
Res 2002; 14 Suppl 2:S33-S41.
Glina S, Bertero E, Claro J, Damião R, Faria G, Fregonesi A, Jaspersen J, Mendoza A, Mattos D, Jr., Rocha LC, Sotomayor M, Telõken C, Ureta S, Zonana E,
SIL42
Ugarte F: Efficacy and safety of sildenafil citrate for the treatment of erectile dysfunction in Latin America. Braz J Urol 2001; 27(2):148-154.
Glina S, Bertero E, Claro J, Damiao R, Faria G, Fregonesi A, Jaspersen J, Mendoza A, Mattos D, Jr., Rocha LC, Sotomayor M, Teloken C, Ureta S, Zonana E,
Ugarte F: Efficacy and safety of flexible-dose oral sildenafil citrate (Viagra) in the treatment of erectile dysfunction in Brazilian and Mexican men. Int J Impot
Res 2002; 14 Suppl 2:S27-S32.
SIL43
Gomez F, Davila H, Costa A, Acuna A, Wadskier LA, Plua P, Andean Group of Erectile Dysfunction Study.: Efficacy and safety of oral sildenafil citrate
(Viagra) in the treatment of male erectile dysfunction in Colombia, Ecuador, and Venezuela: a double-blind, multicenter, placebo-controlled study. Int J Impot
Res 2002; 14 Suppl 2:S42-S47.
SIL53
Albuquerque DC, Miziara LJ, Saraiva JF, Rodrigues US, Ribeiro AB, Wajngarten M: Efficacy, safety and tolerability of sildenafil in Brazilian hypertensive
patients on multiple antihypertensive drugs. Int Braz J Urol 2005; 31(4):342-353.
PG trials-flexible dose – Europe
Dinsmore WW, Hodges M, Hargreaves C, Osterloh IH, Smith MD, Rosen RC: Sildenafil citrate (Viagra) in erectile dysfunction: near normalization in men with
SIL32
broad-spectrum erectile dysfunction compared with age-matched healthy control subjects.[erratum appears in Urology 1999 May;53(5):1072]. Urology 1999;
53(4):800-805.
Hodges M, Hargreaves C, Smith MD. Sildenafil (Viagra), an oral treatment for erectile dysfunction (ED): a 12-week, double-blind, placebo-controlled study
(abstract). Int J Impot Res 9[Suppl 1 (abstract A56)], S46. 1997.
SIL36
Boulton AJ, Selam JL, Sweeney M, Ziegler D: Sildenafil citrate for the treatment of erectile dysfunction in men with Type II diabetes mellitus. Diabetologia
2001; 44(10):1296-1301.
Boulton AJM, Ziegler D, Sweeney M: The first study of sildenafil for erectile dysfunction in men with type 2 diabetes mellitus. Diabetes 2000; 49(Suppl. 1
abstract 143-OR):A35.
Ziegler D, Sellam R, Boulton AJM, Sweeney M, Corporate author DRID, Corporate author UM, Corporate author P: Sildenafil citrate for treatment of erectile
dysfunction in men with type 2 diabetes mellitus. Diabetologia 2000; 43(Suppl. 1 (abstract 968)):A252.
Ziegler D, Sweeney M, Boulton AJM, Corporate author UD, Corporate author P, Corporate author UM: Treatment of erectile dysfunction with sildenafil in men
with Type 2 diabetes: a randomized, placebo-controlled, double-blind study. (Ger.). Exp-Clin-Endocrinol-Diabetes 2000; 108(Suppl. 1 (abstract pFr101)):S158.
SIL37
Cuzin B, Emrich H, Meuleman E, et al. Sildenafil (Viagra): a six-month, double-blind, placebo-controlled, flexible doe escalation study in patients with erectile
dysfunction. Presented at. Seond meeting of the European Society for impotence Research. European Society of Impotence Research abstract no. 152, 48. 1997.
Feldman R, Meuleman EJ, Steers W: Sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction: analysis of two flexible dose-escalation studies.
Sildenafil Study Group. Int J Clin Pract 1999; Supplement. 102:10-12.
Hartmann U, Meuleman EJ, Cuzin B, Emrich HM, Declercq GA, Bailey MJ, Maytom MC, Smith MD, Osterloh IH: Sildenafil citrate (VIAGRA): analysis of
preferred doses in a European, six-month, double-blind, placebo-controlled, flexible dose-escalation study in patients with erectile dysfunction. Multicentre
Study Group. Int J Clin Pract 1999; Supplement. 102:27-29.
Meuleman E, Cuzin B, Opsomer RJ, Hartmann U, Bailey MJ, Maytom MC, Smith MD, Osterloh IH: A dose-escalation study to assess the efficacy and safety of
sildenafil citrate in men with erectile dysfunction. BJU Int 2001; 87(1):75-81.
SIL44
Lindsey I, George B, Kettlewell M, Mortensen N: Randomized, double-blind, placebo-controlled trial of sildenafil (Viagra) for erectile dysfunction after rectal
excision for cancer and inflammatory bowel disease. Dis Colon Rectum 2002; 45(6):727-732.
SIL50
Tignol J: Efficacy of sildenafil citrate for the treatment of erectile dysfunction in men in remission from depression after treatment with or without serotonin
reuptake inhibitors. Int J Neuropsychopharmacol 2004; 7(Suppl. 1 (abstract P02.541)):S447.
Tignol J, Furlan PM, Gomez-Beneyto M, Opsomer R, Schreiber W, Sweeney M, Wohlhuter C: Efficacy of sildenafil citrate (Viagra) for the treatment of erectile
dysfunction in men in remission from depression. Int Clin Psychopharmacol 2004; 19(4):191-199.
Tignol JL, Benkert O: Sildenafil citrate effectively treats erectile dysfunction in men who have been successfully treated for depression. 2001 Annual Meeting of
the American Psychiatric Association; May 5-10; New Orleans; LA, USA 2001.
Tignol JL: Sildenafil citrate effectively treats erectile dysfunction in men who have been successfully treated for depression. 155th Annual Meeting of the
American Psychiatric Association; May 18-23rd; Philadelphia, PA, USA 2002.
SIL54
Olsson AM, Persson CA, for the Swedish Sildenafil Investigators Group: Sildenafil citrate for the treatment of erectile dysfunction in men with cardiovascular
disease (abstract). J Urol 2000; 163:200.
Olsson AM, Persson CA, Corporate author P: Efficacy and safety of Viagra (Sildenafil citrate) in men with cardiovascular disease and erectile dysfunction. JAm-Coll-Cardiol 2000; 35(2, Suppl. A):329A.
Olsson AM, Persson CA, Swedish Sildenafil Investigators Group.: Efficacy and safety of sildenafil citrate for the treatment of erectile dysfunction in men with
cardiovascular disease. Int J Clin Pract 2001; 55(3):171-176.
SIL56
Bailey M, Hodges M, Osterloh I, et al. Sildenafil (Viagra), a new oral treatment for erectile dysfunction: results of an 8-week double-blind, placebo-controlled
parallel group study. Br.J.Urol. 79[Suppl 4 abstract 63], 19. 1997.
Christiansen E, Guirguis WR, Cox D, Osterloh IH, Sildenafil Multicentre Study Group.: Long-term efficacy and safety of oral Viagra (sildenafil citrate) in men
with erectile dysfunction and the effect of randomised treatment withdrawal. Int J Impot Res 2000; 12(3):177-182.
Guirguis WR, Hodges M. Sildenafil, a new oral treatment for erectile dysfunction: an eight-week, double-blind, placebo-controlled,parallel group study. 150th
Annual Meeting of the American Psychiatric Association, San Diego, California, USA. 17-22 May, 1997.
Virag R, Hodges M, Hollingshead M, et al. Sildenafil (Viagra), a new oral treatment for erectile dysfunction: An 8-week double-blind, placebo-controlled
parallel group study. Int J Impot Res 8[abstract A70], 116. 1997.
SIL68
Escobar-Jimenez F, Grupo de Estuido Espanol sobre Sildenafilo.: [Efficacy and safety of sildenafil in men with type 2 diabetes mellitus and erectile
dysfunction]. [Spanish]. Med Clin (Barc ) 2002; 119(4):121-124.
PG trials-flexible dose – Asia and Australia
Lim PH, Ng FC, Cheng CW, Wong MY, Chee CT, Moorthy P, Vasan SS: Clinical safety profile of sildenafil in Singaporean men with erectile dysfunction: preSIL34
ASSESS- marketing experience (ASSESS-I evaluation). J Int Med Res 2002; 30(2):137-143.
1
Tan HM, Moh CL, Mendoza JB, Gana T, Albano GJ, de la CR, Chye PL, Sam CC: Asian sildenafil efficacy and safety study (ASSESS-1): a double-blind,
placebo-controlled, flexible-dose study of oral sildenafil in Malaysian, Singaporean, and Filipino men with erectile dysfunction. The Assess-1 Study Group.
Urology 2000; 56(4):635-640.
SIL35
ASSESS3
SIL46
ASSESS2
SIL47
Chen KK, Hsieh JT, Huang ST, Jiaan DB, Lin JS, Wang CJ, Study Group.: ASSESS-3: a randomised, double-blind, flexible-dose clinical trial of the efficacy
and safety of oral sildenafil in the treatment of men with erectile dysfunction in Taiwan. Int J Impot Res 2001; 13(4):221-229.
SIL49
ASSESSK
Choi HK, Ahn TY, Kim JJ, Kim SC, Paick JS, Suh JK, Kim HS, Kim YK, Lee WH, Oh BH, Park CH, Ryu WS, Chung TG, Kim SW, Lee WH, Moon DG, Ryu
DS, Seo KK, Kim DK, Lee DS: A double-blind, randomised- placebo, controlled, parallel group, multicentre, flexible-dose escalation study to assess the efficacy
and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea. Int J Impot Res 2003; 15(2):80-86.
SIL66
He XQ, Hong BF, Wang XX, Song JC: Evaluation of efficacy and safety of oral sildenafil citrate therapy for men with erectile dysfunction. Pharmaceutical
Journal of Chinese Peoples Liberation Army 2002; 18(4):205-208.
SIL67
Yang DZ, Ma XN, Yu ZJ, Jiao Y: Assessment of curative effect on erectile dysfunction of two drugs. Zhonghua nan ke xue = National journal of andrology
2003; 9(4):260-262.
SIL69
Guo YL, Zhu JC, Pan TM, et al: Efficacy and safety of oral sildenafil in the treatment of erectile dysfunction. Chinese Journal of Urology 2001; 22(7):389-394.
Kongkanand A, Ratana-Olarn K, Ruangdilokrat S, Tantiwong A, Thai investigators in ASSE: The efficacy and safety of oral sildenafil in Thai men with erectile
dysfunction: a randomized, double-blind, placebo controlled, flexible-dose study. J Med Assoc Thai 2003; 86(3):195-205.
Levinson IP, Khalaf IM, Shaeer KZ, Smart DO: Efficacy and safety of sildenafil citrate (Viagra) for the treatment of erectile dysfunction in men in Egypt and
South Africa. Int J Impot Res 2003; 15 Suppl 1:S25-S29.
PG trials-flexible dose – Combined regions
Murphy L, Stuckey B, Jadzinsky MN, Montorsi F, Kadioglu A: Sildenafil citrate for erectile dysfunction in men with type 1 diabetes mellitus. Diabetes 2001;
SIL48
50(Suppl. 2 abstract 393):A99.
Stuckey BG, Jadzinsky MN, Murphy LJ, Montorsi F, Kadioglu A, Fraige F, Manzano P, Deerochanawong C: Sildenafil citrate for treatment of erectile
dysfunction in men with type 1 diabetes: results of a randomized controlled trial.[see comment]. Diabetes Care 2003; 26(2):279-284.
SIL52
Fowler C, Miller J, Sharief M. Viagra (sildenafil citrate) for the treatment of erectile dysfunction in men with multiple sclerosis. J Neurol.Neurosurg.Psychiatry
69: 413 157[497 (abstract)]. 2000.
Fowler CJ, Miller JR, Sharief MK, Hussain IF, Stecher VJ, Sweeney M: A double blind, randomised study of sildenafil citrate for erectile dysfunction in men
with multiple sclerosis. J Neurol Neurosurg Psychiatry 2005; 76(5):700-705.
SIL55
Althof SE, O'Leary MP, Cappelleri JC, Hvidsten K, Stecher VJ, Glina S, King R, Siegel RL, International SSG: Sildenafil citrate improves self-esteem,
confidence, and relationships in men with erectile dysfunction: Results from an international, multi-center, double-blind, placebo-controlled trial. J Sex Med
2006; 3(3):521-529.
Calvo Dominguez D, Villalobos RB, Francolugo-Velez V, Moy-Eransus C, Bravo AR, Gabbler PC, Perez-Toriz U, Rivera AR, Farca EZ. Assessing self-esteem,
confidence and relationships in me with erectile dysfunction treated with Viagra (Sildenafil citrate): Results from Mexican centres of an international multicenter
double-blind placebo-controlled trial. J Sex Med 1[suppl 1 abstract O45], 43. 2004.
Cappelleri J, Duttagupta S, Sherman N, Stecher VJ, Siegel RL, Tseng LJ. Linking self-esteem, confidence, and relationships with severity of erectile
dysfunction. Int Soc Qual Life Res, Oct 2004 Hong Kong [abstract 106], 34.
Cappelleri JC, Duttagupta S, Sherman N, Stecher VJ, Siegel RL, Tseng L, Glina S. Self-esteem, confidence and relationships in men with erectile dysfynction
treated with sildenafil: an international study. J Gen Intern Med 19[suppl 1], 209. 2004.
Glina S, Cappelleri J, Duttagupta S, Sherman N, Stecher V, Siegel R, Tseng LJ: Responsiveness of the Self-Esteem And Relationship questionnaire in men with
erectile dysfunction treated with Viagra(R) (sildenafil citrate): Results from an international, double-blind, placebo- controlled Trial. Eur Urol Supplements
2004; 3(2):103 abstract 402.
King R, Glina S, Cappelleri J, Duttagupta S, Sherman N, Stecher V, Siegel R, Tseng L. Assessing self-esteem, confidence, and relationships in men with erectile
dysfunction treated with VIAGRA (sildenafil citrate): results from an international, multicenter double-blind, placebo-controlled trial. BJU-Int [abstract MP10.10], 68. 2004.
Pfizer. Protocol A1481119: An international multicenter, randomized, parallel-group, double-blind placebo controlled, flexible dose escalation study to evaluate
self-esteem and overall relationships in men with erectile dysfunction treated with Viagra (sildenafil citrate). www.clinicalstudyresults.org, 2003.
Stecher V: Assessing Self-Esteem, Confidence, and Relationships in Men With Erectile Dysfunction Treated With Sildenafil Citrate: Results From an
International, Multicenter, Double-Blind, Placebo-Controlled Trial. 157th Annual Meeting of the American Psychiatric Association; May 1-6; New York, NY
NR230p. 2004.
Takei M, Takamoto H, Glina S, Cappelleri J, Duttagupta S, Sherman N, Stecher V, Siegel L, Tseng LJ. Relationship between erectile functioning and
psychosocial functioning following treatment with viagra (sildenafil citrate): results from an international trial. Quality of Life Research 13[abstract 1347], 1558.
2004.
SIL59
Fava M, Nurnberg HG, Seidman SN, Hooloway W, Farmer M, Nicolas S, Stecher V: Efficacy and safety of sildenafil citrate in men with serotonergicantidepressant-associated erectile dysfunction: Results of a prospective, multicenter, randomized, double-blind, placebo-controlled trial. 156th Annual Meeting
of the American Psychiatric Association, May 17-22, San Francisco CA 2003 No. 111.
Fava M, Nurnberg HG, Seidman SN, Holloway W, Nicholas S, Tseng LJ, Stecher VJ: Efficacy and safety of sildenafil in men with serotonergic antidepressantassociated erectile dysfunction: results from a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 2006; 67(2):240-246.
SIL60
Pfizer. Protocol A1481161: An international, multicentre, randomized, parallel-group, double blind, placebo controlled, flexible dose study to evaluate selfesteem and relationships in male with erectile dysfunction treated with sildenafil citrate. 2005. www.clinicalstudiesresults.org
Moncada II, Koskimaki J, Rodriguez VL, Jimenez S, Chaves J: Treatment with sildenafil improves self-esteem in patients with erectile dysfunction. A doubleblind, placebo-controlled study using the sear (self-esteem and relationship) questionnaire. European Urology Supplements 2006; 5(2 (abstract 466)):139.
PG trials-flexible dose – Region not clear
Blonde L, Feiner C, Siegel R: Partners' evaluation of the efficacy of Viagra (sildenafil citrate) for the treatment of erectile dysfunction was studied in men with
SIL62
diabetes. Diabetes 1999; 48(Suppl. 1 abstract 385):A89-A90.
Fonseca V, Stecher V, Diuguid C: Patient and partner evaluations of treatment satisfaction with Viagra (sildenafil citrate) for the treatment of erectile
dysfunction in men with diabetes. Diabetes 1999; 48(Suppl. 1 abstract 1496):A342-A343.
Hirsch IB, Korenman SG, Stecher V, Diuguid C: Viagra (sildenafil citrate): efficacy and safety in the treatment of erectile dysfunction (ED) in men with
diabetes. Diabetes 1999; 48(Suppl. 1 abstract 388):A90.
Studies included in review but not included in analysis
Crossover trials (fixed dosing)
Boolell M, Gepi-Attee S, Gingell JC, Allen MJ: Sildenafil, a novel effective oral therapy for male erectile dysfunction.[see comment].
SIL1a
Br J Urol 1996; 78(2):257-261.
Data not presented
separately for first
part
Boolell M, Gepi AS, Gingell C, Allen M: UK-92,480, a new oral treatment for erectile dysfunction. A double- blind, placebo controlled
crossover study demonstrating dose response with rigiscan and efficacy with outpatient diary. J-Urol 1996; 155(5, Suppl.):495A.
SIL1c
Palmer JS, Kaplan WE, Firlit CF: Erectile dysfunction in patients with spina bifida is a treatable condition. J Urol 2000; 164: 958-961.
Palmer JS, Kaplan WE, Firlit CF: Sildenafil citrate for the treatment of erectile dysfunction in the spina bifida male. Pharmacologist
1999; 41(3 (abstract LB106)):122.
Data not presented
separately for first
part Not clear
whether dosing was
fixed or flexible
Palmer JS, Kaplan WE, Firlit CF: Erectile dysfunction in spina bifida is treatable. Lancet 1999; 354(9173):125-126.
Palmer JS, Kaplan WE, Firlit CF, Corporate author UN: Erectile dysfunction is a treatable condition in the spina bifida male. Pediatrics
1999; 104(3, Pt. 3):809-810.
SIL1d
Price D, Wareham K, Gingell CJ, Gepi AS, Pearson J, Boolell M: Sildenafil (Pfizer UK-92,480), a novel oral treatment for erectile
dysfunction (ED) in patients with diabetes. Diabetes 1996; 45(Suppl. 2 (abstract 15)):6A.
Data not presented
separately for first
part
Price DE, Gingell JC, Gepi-Attee S, Wareham K, Yates P, Boolell M: Sildenafil: study of a novel oral treatment for erectile dysfunction
in diabetic men. Diabet Med 1998; 15(10):821-825.
SIL1e
Pfizer. Study 148-350: A double blind, randomised, placebo controlled, two way crossover pilot study to investigate the efficacy and
safety of UK-92,480 (sildenafil, 25 tid for 7 days) in patients with impotence. 1998.
No quantified data
SIL1f
Ryder REJ, Kitchen MM, Dewsbury JA, Howells MG, Ryan PG, Taylor KG, Jones SL: What determines response or non-response to
Viagra in diabetic erectile dysfunction? - Is it vascular, neuropathic, hormonal or psychogenic factors, or is it severity? Diabetologia
2001; 44(Suppl. 1):A294.
SIL1g
Bawa AS, Sharma DR, Singh R, Singh P: Efficacy and tolerability of sildenafil in Indian males with erectile dysfunction: A doubleblind, randomized, placebo-controlled, crossover study (4). Indian Journal of Pharmacology 2004; 36(5):317.
SIL1h
Bocchi EA, Guimaraes G, Bellotti G, Ramires JAF, Corporate author US: Beneficial effects of a phosphodiesterase type 5 inhibitor
(sildenafil) on exercise, neurohormonal activation, and erectile dysfunction in patients with congestive heart failure - a double-blind
placebo-controlled cross-over randomized study. J-Am-Coll-Cardiol 2001; 37(2, Suppl. A):163A.
Rosano GM, Mercuro G, Leonardo F, Pagnotta P, Patrizi R, Fini M, Corporate author UC: Report of erectile dysfunction after therapy
with beta-blockers is related to patient knowledge of side effects and is reversed by both sildenafil citrate and placebo. J Am Coll
Cardiol 2002; 39(5, Suppl. A (abstract 851-5)):321A.
There are some
results but probably
refer to overall
treatment period
Data not presented
separately for first
part of trial
Data not presented
separately for first
part of trial
Data not presented
separately for first
part of trial
SIL1i
Silvestri A, Galetta P, Cerquetani E, Marazzi G, Patrizi R, Fini M, Rosano GM: Report of erectile dysfunction after therapy with betablockers is related to patient knowledge of side effects and is reversed by placebo.[see comment]. Eur Heart J 2003; 24(21):1928-1932.
Crossover trials (flexible dosing)
Incrocci L, Koper PC, Hop WC, Slob AK: Sildenafil citrate (Viagra) and erectile dysfunction following external beam radiotherapy for
SIL2a
prostate cancer: a randomized, double-blind, placebo-controlled, cross-over study. Int J Radiat Oncol Biol Phys 2001; 51(5):1190-1195.
Data not presented
separately for first
part
Incrocci L, Koper P, Hop W, Bakri L, Slob K: Sildenafil (Viagra(R)) and erectile dysfunction following conformal radiotherapy for
prostate cancer: A randomized, double-blind, placebo-controlled, cross-over study. International Journal of Radiation Oncology Biology
Physics 2001; 51(3 Supplement 1 (abstract 248)):139-140.
Incrocci L, Hop WC, Slob AK: [Favorable effect of sildenafil on erectile dysfunction in patients after radiotherapy for prostate cancer;
randomised, double-blind, placebo-controlled crossover study]. [Dutch]. Ned Tijdschr Geneeskd 2003; 147(35):1687-1690.
SIL2b
Sharma RK, Prasad N: Treatment of erectile dysfunction with sildenafil citrate in renal transplant recipient: a cross over placebo
controlled trial. [abstract]. Transplantation 2004; 78(2 Suppl):293.
Data not presented
separately for first
part
Sharma RK, Prasad N, Gupta A, Kapoor R: Treatment of erectile dysfunction with sildenatil citrate in renal allograft recipients: A
randomized, double-blind, placebo-controlled, crossover trial. Am J Kidney Dis 2006; 48(1):128-133.
Sharma RK, Prasad N, Kapoor R, Gupta A, Gulati,S.: Treatment of erectile dysfunction with sildenatil citrate in renal transplant
recipients: A double-blind, crossover placebo-controlled trial. J Am Soc Nephrol 2003; 14 (abstract SU-PO545): 635(A).
SIL2c
Hultling C, Giuliano F, Quirk F, Pena B, Mishra A, Smith MD: Quality of life in patients with spinal cord injury receiving Viagra
(sildenafil citrate) for the treatment of erectile dysfunction. Spinal Cord 2000; 38(6):363-370.
Data not presented
separately for first
part
Giuliano F, Hultling C, El Masry WS, Stohrer M, Stien R, Maytom MC, Orr M, Smith MD, Osterloh I. Sildenafil (Viagra); a novel oral
treatment for erectile dysfunction (ED) caused by traumatic spinal injury (SCI). Int J Impot Res 10[suppl 3], S33. 1998.
Giuliano F, Hultling C, El Masry WS, Luchner E, Stien R, Maytom MC, Orr M, Smith MD, Osterloh IH: Sildenafil citrate (VIAGRA): a
novel oral treatment for erectile dysfunction caused by traumatic spinal cord injury. Int J Clin Pract 1999; Supplement. 102:24-26.
Giuliano F, Hultling C, El Masry WS, Smith MD, Osterloh IH, Orr M, Maytom M: Randomized trial of sildenafil for the treatment of
erectile dysfunction in spinal cord injury. Sildenafil Study Group. Ann Neurol 1999; 46(1):15-21.
Holmgren E, Giuliano F, Hultling C, Stohrer M, ElMasri WS, Stien R, Maytom M, Orr M, Smith MD, Osterloh IH: Sildenafil
(VIAGRA(TM)) in the treatment of erectile dysfunction (ED) caused by spinal cord injury (SCI): A double blind, placebo- controlled,
flexible-dose, two way crossover study. Neurology 1998; 50(S4 abstract P02.133):A127.
Hultling C. Partners’ perceptions of the efficacy of sildenafil citrate (Viagra) in the treatment of erectile dysfunction. IJCP 1999; Suppl
102: 16-17.
SIL2d
SIL2e
SIL2f
Hussain IF, Brady CM, Swinn MJ, Mathias CJ, Fowler CJ: Treatment of erectile dysfunction with sildenafil citrate (Viagra) in
parkinsonism due to Parkinson's disease or multiple system atrophy with observations on orthostatic hypotension.[see comment]. J
Neurol Neurosurg Psychiatry 2001; 71(3):371-374.
Gopalakrishnan R, Jacob KS, Kuruvilla A, Vasantharaj B, John JK: Sildenafil in the treatment of antipsychotic-induced erectile
dysfunction: a randomized, double-blind, placebo-controlled, flexible-dose, two-way crossover trial. Am J Psychiatry 2006; 163(3):494499.
Data not presented
separately for first
part
Data not presented
separately for first
part
Mahon A, Sidhu PS, Muir G, Macdougall IC: The efficacy of sildenafil for the treatment of erectile dysfunction in male peritoneal
dialysis patients. Am J Kidney Dis 2005; 45(2):381-387.
Data not presented
separately for first
part
Macdougall IC, Mahon A, Muir G, Sidhu P: Randomized placebo-controlled study of sildenafil (Viagra) in peritoneal dialysis patients
with erectile dysfunction. J Am Soc Nephrol 1999; 10(PROGRAM AND ABSTR. ISSUE abstract 1609):318A.
SIL2g
Eardley I, Morgan R, Dinsmore WW, et al. Oral administration of sildenafil improves penile erectile in patients with male erectile
dysfunction (MED). A double-blind placebo controlled study with patient and partner outpatients diary as efficacy end points. European
Urology 30[abstract 573], 160. 1996.
Data not presented
separately for first
part
Eardley I, Morgan RJ, Dinsmore WW, Pearson J, Wulff MB, Boolell M: UK-92,480, a new oral therapy for erectile dysfunction, a
double- blind, placebo controlled trial with treatment taken as required. J-Urol 1996; 155(5, Suppl. abstract 737):495A.
Eardley I, Morgan R, Dinsmore W, Yates P, Boolell M: Efficacy and safety of sildenafil citrate in the treatment of men with mild to
moderate erectile dysfunction. Br J Psychiatry 2001; 178:325-330.
Parallel groups trials
Deveci S, Peskircioglu L, Aygun C, Tekin MI, Dirim A, Ozkardes H: Sublingual sildenafil in the treatment of erectile dysfunction: faster
SIL24
onset of action with less dose. Int J Urol 2004; 11(11):989-992.
SIL63
SIL64
Ginsberg D, Adler L, McCullough A, Ying P, Woo K. A double blind placebo controlled study of the use of sildenafil for the treatment
of serotonin-reuptake inhibitor-induced sexual dysfunction (SRISD). International Journal of Impotence Research 13[Suppl 5 (abstract
9)], S61. 2001.
Mancia G, Pickering TG, Glasser DB, Orazem J: Efficacy of VIAGRA(R) (sildenafil citrate) in men with erectile dysfunction and
arterial hypertension who are taking multiple antihypertensive treatments. Am J Hypertens 2002; 15(4 Part 2):55A.
No data on our
selected outcomes
No quantified data
Number of patients
per group not clear
Fogari R, Glasser DB, Orazem J, Mancia G, Corporate author UP, Corporate author P, Corporate author UMB: Efficacy of Viagra
(sildenafil citrate) in men with erectile dysfunction, treated hypertension, and ischemic heart disease. J-Hypertens 2003; 21(Suppl. 4
abstact P2.220):S184.
Puddey IB, Sutherland P, McLachlan R, Pollock C, Stowasser M, Mancia G, Pickering TG, Corporate author UWA. Safety and efficacy
of sildenafil citrate in men with erectile dysfunction and hypertension who are taking multiple antiypertensive treatments. Clin-ExpPharmacol-Physiol 30[7], A59-A60. 2003.
Shepherd AM, Glasser DB, Sherman N, Orazem J: Efficacy and safety of sildenafil citrate in patients with erectile dysfunction and
diabetes mellitus taking multiple antihypertensive agents. Diabetes 2002; 51(Suppl. 2 (abstract 1738-P)):A423.
Taylor S, Glasser DB, Sherman N, Corporate author CCRC, Corporate author P: Efficacy and safety of sildenafil citrate in men with
erectile dysfunction who are taking multiple antihypertensives. Eur-Heart-J 2002; 23(Abstr.Suppl. (abstract P1165):211.
SIL70
Heiman JR, Talley DR, Bailen JL, Shumel B, Pace CR, Creanga DL, Bavendam T: Female partners of men with erectile dysfunction
No data on our
treated with sildenafil citrate report greater satisfaction and enjoyment from sexual intercourse: A multicenter, randomized, double-blind,
placebo- controlled study. J Urol 2005; 173(4):5.
Hensley PL, Nurnberg HG, Fava M: Randomized Clinical Trial of Selective PDE-5 Inhibitor (Sildenafil) Treatment of SSRI TreatmentEmergent Erectile Dysfunction. 156th Annual Meeting of the American Psychiatric Association, May 17-22, San Francisco CA 2003;
NR412.
Studies excluded from review due to lack of information
Young S: Women's perceptions of the efficacy of sildenafil (Viagra) in the treatment of erectile dysfunction. Br-J-Obstet-Gynaecol
1998; 105(Suppl. 17 (abstract 403)):126.
Feldman R, Meuleman EJH, Steers W. Sildenafil (Viagra) in the treatment of erectile dysfunction: analysis of two flexible-doseescalation studies. Int J Impot Res 10[suppl 3], S33. 1998.
SIL71
selected outcomes
No data presented.
Abstract only. Not
clearly randomized.
Abstract only. Not
clearly randomized.
Vardenafil vs placebo
Study ID References
Fixed dosing studies
BAYER2003. Trial 100285 (A randomized, double-blind placebo-controlled multicenter, fixed-dose parallel group 3-month comparison study to investigate the
VAR01
efficacy and safety of the phosphodiesterase type V inhibitor BAY 38-9456 in males with erectile dysfunction following radical prostatectomy. FDA website
2003.
Brock G, Nehra A, Lipshultz L, Karlin G, Gleave M, Seger M, Padma-Nathan H. Infuence of vardenafil on erectile dysfunction (ED) and depressive symptoms
postradical prostatectomy. Int J Impot Res 14 [suppl 3], S97. 2002.
Brock G, Taylor T, Seger M, Vardenafil PROSPECT Group Canada. Efficacy and tolerability of vardenafil in men with erectile dysfunction following radical
prostatectomy. European Urology 1[Suppl 1 (abstract 598)], 152. 2002.
Brock G, Nehra A, Lipshultz LI, Karlin GS, Gleave M, Seger M, Padma-Nathan H: Safety and efficacy of vardenafil for the treatment of men with erectile
dysfunction after radical retropubic prostatectomy. J Urol 2003; 170(4 Pt 1):1278-1283.
Grantmyre J, Brock G, Nadel A, Seger M: Efficacy and tolerability of vardenafil in men with ED and residual tumescence following radicalretropubic
prostatectomy (abstract 61). J Androl 2004;(Suppl. S):58.
Nehra A, Grantmyre J, Nadel A, Thibonnier M, Brock G: Vardenafil improved patient satisfaction with erectile hardness, orgasmic function and sexual
experience in men with erectile dysfunction following nerve sparing radical prostatectomy. J Urol 2005; 173(6):2067-2071.
Vezina JG, Nehra A, Brock G, Pommerville P, Seger M, Padma NH: Vardenafil improved patient satisfaction with erection hardness, orgasmic function, and
sexual experience in men with erectile dysfunction following nerve-sparing radical prostatectomy. J-Urol 2003; 169(4, Suppl. abstract 949):245.
VAR02
Donatucci C, Taylor T, Thibonnier M, Bangerter K, Gittelman M, Casey R, Vardenafil Study G: Vardenafil improves patient satisfaction with erection hardness,
orgasmic function, and overall sexual experience, while improving quality of life in men with erectile dysfunction. The journal of sexual medicine 2004;
1(2):185-192.
Donatucci C, Pommerville P, Niederberger C, Thibonnier M, Segerson T, McVary KT, Hellstrom WG: Vardenafil improved patient satisfaction with erection
hardness, orgasmic function, and sexual experience in men with erectile dysfunction. J-Urol 2003; 169(4, Suppl. abstract 950):246.
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(6):763-771.
Hellstrom WJ, Gittelman M, Karlin G, Segerson T, Thibonnier M, Taylor T, Padma-Nathan H, Vardenafil Study Group.: Sustained efficacy and tolerability of
vardenafil, a highly potent selective phosphodiesterase type 5 inhibitor, in men with erectile dysfunction: results of a randomized, double-blind, 26-week
placebo-controlled pivotal trial. Urology 2003; 61(4 Suppl 1):8-14.
Hellstrom WJ, Elhilali M, Homering M, Taylor T, Gittleman M: Vardenafil in patients with erectile dysfunction: achieving treatment optimization. J Androl
2005; 26(5):604-609.
Hellstrom WJG, Gittelman M, Shapiro J, Thibonnier M, Segerson T. Vardenafil improved erectile function in men with a broad range of erectile dysfunction
etiologies and severities: A phase III trial. International Journal of Impotence Research 13[suppl 5 (abstract 25)], S65. 2001.
Hellstrom WJG, Kendirci M, Gittelman M, Karlin GS, Thibonnier M, Segerson T: Vardenafil improves penetration success rates from within 15 minutes to up to
8 hours from time of dosing to start of sexual activity. J Androl 2004;(Suppl. S):93.
Valiquette L, Hellstrom W, Gittelman M, Barkin J, Thibonnier M, Casey R, Pommerville P, Elhilali M, Padma-Nathan H. Vardenafil provides reliable efficacy
over time in men with erectile dysfunction [abstract no CP5.07]. Int-J-Impot-Res 14[Suppl 3], S88. 2002.
VAR03
BAYER2003 Trial 10128 (A randomized, double-blind placebo-and active (Viagra) controlled multicenter, fixed-dose parallel group 3-month comparison study
to investigate the efficacy and safety of the phosphodiesterase type V inhibitor BAY 38-9456 in men with erectile dysfunction. FDA website 2003.
VAR04
Nagao K, Ishii N, Kamidono S, Osada T, Vardenafil (Levitra) Clinical Trial Group.: Safety and efficacy of vardenafil in patients with erectile dysfunction: result
of a bridging study in Japan. Int J Urol 2004; 11(7):515-524.
VAR09
Porst H, Rosen R, Padma-Nathan H, Goldstein I, Giuliano F, Ulbrich E, Bandel T: The efficacy and tolerability of vardenafil, a new, oral, selective
phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial. Int J Impot Res 2001; 13(4):192-199.
Porst H, Rosen R, Padma NH, Goldstein I, Giuliano F, Vardenafil SG: Vardenafil, a new highly selective PDE5 inhibitor, improves erectile function irrespective
of the baseline severity and aetiology of ED or age of patient. Eur Urol 2001; 39(Suppl. 5):17.
Porst H, Schmidt AC, Vardenafil Study Group. Vardenafil improved erectile function regardless of baseline severity, etiology and hypertensive medications in
phase II trial. International Journal of Impotence Research 13[Suppl 5 (abstract 21)], S64. 2001.
Porst H, Young JM, Schmidt AC, Buvat J, International Vardenafil Study Group.: Efficacy and tolerability of vardenafil for treatment of erectile dysfunction in
patient subgroups. Urology 2003; 62(3):519-523.
Young J, Auerbach SM, Porst H: Vardenafil, a new selective PDE5 inhibitor, significantly improved all IIEF domains and showed a favorable safety profile in
patients with erectile dysfunction over 12 weeks. J-Urol 2001; 165(5, Suppl. abstract 924):224.
VAR11
VAR10
Montorsi F, Padma NH, Buvat J, Schwaibold H, Beneke M, Ulbrich E, Bandel TJ, Porst H, Vardenafil Study G: Earliest time to onset of action leading to
successful intercourse with vardenafil determined in an at-home setting: a randomized, double-blind, placebo-controlled trial. The journal of sexual medicine
2004; 1(2):168-178.
van Ahlen HV, Cuzin B, Rodriguez VL, Beneke M, Bandel TJ, Ulbrich ET, Montorsi F, Porst H, Corporate author B: Earliest time to onset of action leading to
successful sexual intercourse by vardenafil (Levitra) in men with erectile dysfunction. Andrologia 2004; 36(4 abstract PO023):191-192.
BAYER2003. Trial 100250 (A randomized, double-blind placebo-controlled multi-center, fixed-dose parallel group 3-month comparison study to investigate the
efficacy and safety of the phosphodiesterase type V inhibitor BAY 38-9456 in males with erectile dysfunction and diabetes mellitus. FDA website 2003.
Goldstein I, Young J, Fischer J, Mollen M, Chu F, Shapiro J, Segerson T, Taylor T: Vardenafil, a new highly selective PDE5 inhibitor, improves erectile
function in patients with diabetes mellitus. Diabetes 2001; 50(Suppl. 2 abstract 456):A114.
Goldstein I, Young JM, Fischer J, Yuran T, Taylor T, Vardenafil Diabetes Phase III Group. Vardenafil improved erectile function in diabetis men with erectile
dysfunction. International Journal of Impotence Research 13[Suppl 5 (abstract 24)], S65. 2001.
Goldstein I, Young J, Fischer J, Mollen M, Chu F, Shapiro J, Segerson T, Taylor T. Vardenafil, a new selective PDE 5 inhibitor, significantly improved all IIEF
domains and showed a favorable safety profile in patients with impaired erectile function and diabetes mellitus. International Journal of Impotence Research
13[suppl 5 (abstract 22)], S64. 2001.
Goldstein I, Fischer J, Taylor T, Thibonnier M: Influence of HbA1c on the efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with
diabetes. Diabetes 2002; 51(Suppl. 2 abstract 397):A98.
Goldstein I, Young JM, Fischer JS, Taylor T, Segerson T.: Vardenafil (Levitra) improved patient satisfaction with erectile hardness, orgasmic function, and
sexual experience in men with erectile dysfunction and diabetes irrespective of level of glycemic control. Diabetologia 2003; 46(Suppl. 2 abstract 917):A317.
Goldstein I, Young JM, Fischer J, Bangerter K, Segerson T, Taylor T, Vardenafil Diabetes Study Group.: Vardenafil, a new phosphodiesterase type 5 inhibitor,
in the treatment of erectile dysfunction in men with diabetes: a multicenter double-blind placebo-controlled fixed-dose study. Diabetes Care 2003; 26(3):777783.
Fischer J, Young J, Yale JF, Homering M, Taylor T, Goldstein I: Vardenafil increases the percent of patients achieving initial SEP2 /SEP3 success by the 3(rd)
attempt in diabetic men with erectile dysfunction. Diabetes 2004; 53(Suppl. 2 (abstract 110-OR)):A26.
Young J, Goldstein I, Fischer J, Segerson T, Taylor T: Vardenafil (Levitra) improved satisfaction with erectile hardness, orgasmic function, and sexual
experience in men with diabetes with erectile dysfunction. Diabetes 2003; 52(Suppl. 1 abstract 68-OR):A16.
VAR12
Valiquette L, Young JM, Moncada I, Porst H, Vezina JG, Stancil BN, Edmunds K, Montorsi F, Vardenafil Study Group.: Sustained efficacy and safety of
vardenafil for treatment of erectile dysfunction: a randomized, double-blind, placebo-controlled study. Mayo Clin Proc 2005; 80(10):1291-1297.
VAR18
Kimoto Y, Iwamoto Y, Tachibana T, Fujikawa K, Ishii N, Kamidono S: Vardenafil 20-mg demonstrated superior efficacy to 10-mg in Japanese men with
diabetes mellitus suffering from erectile dysfunction. Diabetologia 2005; 48(Suppl. 1):A367-A368.
Flexible dosing studies
Hatzchristou D, Montorsi F, Porst H, Taylor T, Bandel T, Corporate author UTA, Corporate author IS, Corporate author B: Efficacy of vardenafil in a flexible
VAR05
dose regimen: a placebo- controlled trial. J-Am-Geriatr-Soc 2003; 51(4, Suppl. abstract P171):S101.
Hatzichristou D, Montorsi F, Porst H, Buvat J, Taylor T, Bandel T. A flexible dose regimen of vardenafil for erectile dysfunction: a placebo-controlled trial.
European Urology Suppl. 2[1], 176. 2003.
Hatzichristou D, Montorsi F, Buvat J, Laferriere N, Bandel TJ, Porst H, European Vardenafil Study Group.: The efficacy and safety of flexible-dose vardenafil
(levitra) in a broad population of European men. Eur Urol 2004; 45(5):634-641.
Hatzichristou D, Cuzin B, Martin-Morales A, Buvat J, Porst H, Laferriere N, Bandel TJ, Montorsi F, Vardenafil Study Group.: Vardenafil improves satisfaction
rates, depressive symptomatology, and self-confidence in a broad population of men with erectile dysfunction. J Sex Med 2005; 2(1):109-116.
VAR06
Rodriguez VL, Montorsi F, Shabsigh R, Bangerter K, Seger M, Corporate author UZ, Corporate author UVS, Corporate author UC, Corporate author B:
Vardenafil is reliable in the treatment of men with ED and untreated mild major depressive disorder. Andrologia 2004; 36(4 abstract PO025):192-193.
Rosen R, Montorsi F, Assalian P, Rodriguez-Vela L, Porto R, Bangerter K. Efficacy and tolerability of vardenafil in men with mild major depressive disorder
and erectile dysfunction: the Depression Related Improvement with Vardenafil for Erectile Response (DRIVER) study. European Urology Suppl 3[2 (abstract
LB14)], 235. 2004.
Rosen R, Shabsigh R, Berber M, Assalian P, Menza M, Rodriguez-Vela L, Porto R, Bangerter K, Seger M, Montorsi F, Vardenafil SS, I: Efficacy and
tolerability of vardenafil in men with mild depression and erectile dysfunction: the depression-related improvement with vardenafil for erectile response study.
Am J Psychiatry 2006; 163(1):79-87.
VAR07
Carson C, Hatzichristou D, Carrier S, Lording D, Young J, Murdock M, for the Vardenafil Study Group. Vardenafil exhibits efficacy in men with erectile
dysfunction unresponsive to prior sildenafil therapy: results of a phase-III clinical trial-Patient RespOnse withVarddENafil in sildenafil non-responders
(PROVEN). International Journal of Impotence Research 15[suppl 5 (abstract 31)], S175. 2003.
Carson CC, Hatzichristou DG, Carrier S, Lording D, Lyngdorf P, Aliotta P, Auerbach S, Murdock M, Wilkins HJ, McBride TA, Colopy MW, Patient Response
with Vardenafil in Slidenafil Non-Responders (PROVEN) Study Group.: Erectile response with vardenafil in sildenafil nonresponders: a multicentre, doubleblind, 12-week, flexible-dose, placebo-controlled erectile dysfunction clinical trial.[erratum appears in BJU Int. 2005 Aug;96(3):466]. BJU Int 2004; 94(9):13011309.
Hatzichristou D, Carrier S, Carson C, Lording D, Young J. Vardenafil in efficacious in men with erectile dysfunction unresponsive to prior Sildenafil therapy:
Results of a phase-III clinical trial - patient response with Vardenafil in Sildenafil nonresponders (PROVEN). International Journal of Impotence Research
15[Suppl 6 (PS-2-6)], S5. 2003.
Hatzichristou D, Carson C, Lording D, Lyngdorf P, Aliotta P, Vardenafil SGPP: Vardenafil allows rapid and reliable erection achievement: Results of the patient
response with vardenafil in sildenafil nonresponders (proven) Trial. European Urology Supplements 2004; 3(2 (abstract 405)):104.
Murdock M, Carson C, Aliotta P, Hatzichristou D, Auerbach S, Carrier S, Lording D, Lyngdorf P: Regardless of glycemic control, vardenafil significantly
improves erectile function in diabetics who are sildenafil nonresponders: PROVEN trial results. Diabetes 2004; 53(S2 abstract 585-P):A139.
Murdock M, Carson C, Aliotta P, Hatzichristou D, Auerbach S, Carrier S, Lording D, Lyngdorf P: Regardless of glycemic control, vardenafil significantly
improves intercourse success rates in sildenafil nonresponders: PROVEN trial results. Diabetes 2004; 53(Suppl. 2 (abstract 109-OR)):A26.
VAR08
Giuliano F, Rubio-Aurioles E, Kennelly M, Montorsi F, Kim ED, Finkbeiner AE, Pommerville PJ, Colopy MW, Wilkins HJ, Wachs BH, Vardenafil Study
Group.: Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury. Neurology 2006; 66(2):210-216.
VAR14
Fisher WA, Rosen RC, Mollen M, Brock G, Karlin G, Pommerville P, Goldstein I, Bangerter K, Bandel TJ, Derogatis LR, Sand M: Improving the sexual quality
of life of couples affected by erectile dysfunction: a double-blind, randomized, placebo-controlled trial of vardenafil. J Sex Med 2005; 2(5):699-708.
Goldstein I, Fisher WA, Sand M, Rosen RC, Mollen M, Brock G, Karlin G, Pommerville P, Bangerter K, Bandel TJ, Derogatis LR, Vardenafil Study Group.:
Women's sexual function improves when partners are administered vardenafil for erectile dysfunction: a prospective, randomized, double-blind, placebocontrolled trial. J Sex Med 2005; 2(6):819-832.
Deng C, Sun X: Evaluating the treatment satisfaction of vardenafil in men with erectile dysfunction and female partners by the Treatment Satisfaction Scale.
Zhonghua nan ke xue = National journal of andrology 2005; 11(9):716-719.
VAR15
Ziegler D, Merfort F, van AH, Reblin T, Neureither M: Efficacy and safety of vardenafil, a selective phosphodiesterase 5 inhibitor, in type 1 diabetic patients
with erectile dysfunction. Diabetes 2005; 54(Suppl. 1):A127.
Van Ahlen H, Wahle K, Kupper W, Yassin A, Reblin T, Neureither M: Safety and efficacy of vardenafil, a selective phosphodiesterase 5 inhibitor, in patients
with erectile dysfunction and arterial hypertension treated with multiple antihypertensives.[erratum appears in J Sex Med. 2006 Jan;3(1):190]. J Sex Med 2005;
2(6):856-864.
VAR19
Meryn S, Sharlip I, Hatzichristou D, Rubio-Aurioles E, Gittleman M, Stancil BN, Wilkins HJ, Pommerville P, Porst H. Efficacy and tolerability of flexible-dose
vardenafil when taken 8 hours before intercourse: the extended duration of vardenafil in erectile dysfunction (extend) trial. J Sex Med 3[suppl 3], 180. 2006.
Studies included in review but not included in analysis
Sperling H, Porst H, Corporate author UE: Vardenafil - low dose study: a phase III, randomized, double blind, double dummy,
VAR 13
Reason excluded:
placebo-controlled, multicentre, fixed-dose (2.5 and 5 mg), parallel-group study to investigate the efficacy and safety of vardenafil in
men with erectile dysfunction (ED). Andrologia 2004; 36(4 abstract PO033):196-197.
VAR 16
VAR17
Sachse R, Rohde G, Stark S, Klotz T: Safety, tolerability and pharmacokinetics of BAY 38-9456 in patients with erectile
dysfunction. J-Urol 2000; 163(4, Suppl. abstract 904):204.
VAR20
Kell P, Collins O, Dean J, Edwards D, Ralph D, Eardley I. Efficacy of phosphodiesterase type 5 inhibition in severly affected
erectile dysfunction patients with an erectile function domain score of five. J Sex Med 3[suppl 3], 182. 2006.
Studies excluded from review due to lack of information
Demir E et al Efficacy and safety of vardenafil in renal transplant recipients with erectile dysfunction Transpl Proc 2006; 38 (5): 1379-81.
Abstract only, numbers
of patients per group not
clear
Reason excluded:
Results not presented for
first part of trials
Reason excluded:
Abstract only, numbers
of patients per group not
clear
The methods and results
are suggestive of a casecontrol rather than RCT
design
Steidle C, Porst H, Hollister A, Segerson T. Vardenafil demonstrated similar efficacy and tolerability among older and younger patients with
marginal differences in PK characteristics between age groups. International Journal of Impotence Research 13[Suppl 5 (abstract 15)], S63. 2001.
No numbers given for
each group.
Padma-Nathan H, Kaufman J, Taylor T. Earliest time of onset of erections with vardenafil determined in an at-home setting. Journal of Andrology
24[48 (abstract 41)]. 2003.
No numbers given for
each group
Tadalafil versus placebo
Study
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TAD01
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Carrier S, Brock GB, Pommerville PJ, Shin J, Anglin G, Whitaker S, Beasley CM, Jr.: Efficacy and safety of oral tadalafil in the treatment of men in Canada
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TAD07
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Lilly ICOS. Study LVCE: A randomized, double-blind placebo-controlled study of the efficacy and safety of IC351 (LY450190) administrered 'on demand' to
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TAD03
Lilly ICOS. Study LVBK: A randomized, double-blind placebo-controlled study of the efficacy and safety of IC351 (LY450190) administrered 'on demand' to
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Saenz De Tejada I, Emmick J, Anglin G, Fredlund P, Pullman W: The effect of as-needed IC351 treatment of erectile dysfunction in men with diabetes.
Diabetologia 2001; 44(Suppl. 1 abstract 1130):A295.
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Saenz dTI, Emmick J, Anglin G, Fredlund P, Pullman W: The effect of on-demand IC351 treatment of erectile dysfunction in men with diabetes. Eur Urol 2001;
39(Suppl. 5):16.
Saenz DT, I, Fredlund P, Anglin G, Pullman B, Emmick J: Cialis (IC351) as a treatment of erectile dysfunction in diabetic men. Diabetes 2001; 50(Suppl. 2
abstract 1768-PO):A425.
Saenz DT, I, Anglin G, Knight JR, Emmick JT: Effects of tadalafil on erectile dysfunction in men with diabetes.[see comment]. Diabetes Care 2002;
25(12):2159-2164.
TAD09
Eardley I, Gentile V, Austoni E, Hackett G, Lembo D, Wang C, Beardsworth A: Efficacy and safety of tadalafil in a Western European population of men with
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TAD14
De Rose AF, Gallo F, Carmignani G: Evaluation of sexual activity in patients treated with tadalafil: a randomized prospective placebo-controlled trial. Int J
Impot Res 2005; 17(1):76-79.
TAD10
Skoumal R, Chen J, Kula K, Breza J, Calomfirescu N, Basson BR, Kopernicky V: Efficacy and treatment satisfaction with on-demand tadalafil (Cialis) in men
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Asia / Australia
Chen KK, Jiann BP, Lin JSN, Lee SS, Huang ST, Wang CJ, Ju TH, Su CK, Costigan TM, Emmick JT: Efficacy and safety of on-demand oral tadalafil in the
TAD04
treatment of men with erectile dysfunction in Taiwan: a randomized, double-blind, parallel, placebo-controlled clinical study (erratum in J Sex Med 2005;
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TAD05
Lilly ICOS. Study LVCQ: A randomized, double-blind placebo-controlled study of the efficacy and safety of IC351 (LY450190) administrered over three
months 'on demand' to patients with erectile dysfunction. FDA website 2003.
McMahon CG, Stuckey BG, Lording DW, Wittert GA, Murphy A, Shin J, Sutherland PD, Palmer NR, Lowy MP, Jesudason DR, Fredlund P: A 6-month study
of the efficacy and safety of tadalafil in the treatment of erectile dysfunction: a randomised, double-blind, parallel-group, placebo-controlled study in Australian
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McMahon CG, Carson CC, Fischer CJ, Wang WC, Florio VA, Bradley JD: Tolerance to the therapeutic effect of tadalafil does not occur during 6 months of
treatment: A randomized, double-blind, placebo-controlled study in men with erectile dysfunction. JOURNAL-OF-SEXUAL-MEDICINE 2006; 3(3):504-511.
TAD12
TAD11
Mixed
TAD08
Saylan M, Khalaf I, Kadioglu A, Shoair KZ, Beheiry A, Wang WC, Kopernicky V, Esen A: Efficacy of tadalafil in Egyptian and Turkish men with erectile
dysfunction. Int J Clin Pract 2006; 60(7):812-819.
Guo YL, Zhu JC, Pan TM, Ding Q, Wang YX, Cheong NF, Lim E, Shen W, Venugopalan M, Chan M: Efficacy and safety of on-demand tadalafil for the
treatment of erectile dysfunction in South-East Asian men. INTERNATIONAL-JOURNAL-OF-UROLOGY 2006; 13(6):721-727.
Seftel AD, Wilson SK, Knapp PM, Shin J, Wang C, Ahuja S. Efficacy and safety of tadalafil in US men with ED. International Journal of Impotence Research
15[suppl 5 (abstract 25)], S172. 2003.
Seftel AD, Wilson SK, Buren V, Knapp P, Shin J, Wang WC, Ahuja S: Efficacy and safety of tadalafil in US men with ED. J-Urol 2003; 169(4, Suppl. abstract
1404):376.
Seftel AD, Wilson SK, Knapp PM, Shin J, Wang WC, Ahuja S: The efficacy and safety of tadalafil in United States and Puerto Rican men with erectile
dysfunction.[erratum appears in J Urol. 2005 Feb;173(2):664]. J Urol 2004; 172(2):652-657.
TAD16
Montorsi F, Ahuja S, Brock G, Broderick G, Hoover A, McCullough A, Murphy A, Novack D, Padma-Nathan H, Varanese L, Whitaker S. Tadalafil in the
treatment of ED following bilateral nerve-sparing radical prostatectomy. International Journal of Impotence Research 15 (suppl 6)[abstract PS-2-3], S4. 2003.
Montorsi F, McCullough A, Brock G, et al. Tadalafil in the treatment of erectile dysfunction following bilateral nerve-sparing radical prostatectomy. IJIR
15[abstract 21], S170-1. 2003.
Montorsi F, Nathan HP, McCullough A, Brock GB, Broderick G, Ahuja S, Whitaker S, Hoover A, Novack D, Murphy A, Varanese L: Tadalafil in the treatment
of erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy: a randomized, double-blind, placebo controlled trial.[erratum appears
in J Urol. 2005 Feb;173(2):664]. J Urol 2004; 172(3):1036-1041.
TAD17
Giuliano F, Porst H, Shen W, Chang S. Safety and efficacy of Cialis (tadalafil) taken daily for the treatment of erectile dysfunction. Int J Impot Res 14[suppl 4
abstract PS-4-6], S16. 2002.
Giuliano F, Glina S, Ralph D, Casabe A, Elion-Mboussa A, Shen W, Stothard D, Whitaker JS, Porst H. The efficacy and safety of tadalafil taken once a day for
up to 1 year for the treatment of erectile dysfunction. J Sex Med 3[suppl 3], 180. 2006.
Buvat J, Faria G, Wetterauer U, von Keitz A., Dinsmore W, Wang WC, Stothard D, Cordell W. Tadalafil 5 mg and 10 mg taken once a day for the treatment of
erectile dysfunction improves patients sexual satisfaction. J Sex Med 3[suppl 3], 182. 2006.
Porst H, Giuliano F, Glina S, Ralph D, Casabé AR, Elion MA, Shen W, Whitaker JS: Evaluation of the Efficacy and Safety of Once-a-Day Dosing of Tadalafil
5 mg and 10 mg in the Treatment of Erectile Dysfunction: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Eur Urol 2006;
50(2):351-359.
TAD06
Unknown
TAD18
Lilly ICOS. Study LVBN: A randomized, double-blind placebo-controlled study of the efficacy and safety of IC351 (LY450190) administrered 'on demand' to
patients with male erectile dysfunction. FDA website 2003.
Padma-Nathan H, McMurray JG, Pullman WE, Whitaker JS, Saoud JB, Ferguson KM, Rosen RC, On-Demand Dosing Study Group.: On-demand IC351 (Cialis)
enhances erectile function in patients with erectile dysfunction. Int J Impot Res 2001; 13(1):2-9.
Giuliano F, Porst H, Padma NH, Saoud J, Ferguson K, Whitaker S, Pullman W, Rosen R: Daily and on-demand IC351 treatment of erectile dysfunction. J-Urol
2000; 163(4, Suppl.(abstract 894)):201.
TAD21
Brock G, Buvat J, Gambla M, Hatzichristou D, Lording D, Rose L, Rubio-Aurioles E, Spera G, Liang S-Y, Frumkin L. Efficacy and safety of tadalafil 2.5 mg
and 5 mg administrered once a day in men with diabetes mellitus and erectile dysfunction. EUROPEAN-UROLOGY-SUPPLEMENTS 5[2 (abstract 465)], 139.
2006.
Studies included in review but excluded of meta-analysis
TAD20
Padma-Nathan H, Rosen RC, Shabsigh R, et al: Cialis (IC351) provides prompt response and extended period of responsiveness for the
treatment of men with erectile dysfunction. J Urol 2001; 165(5):224 abstract 923.
No usable data
Rosen RC, Padma NH, Shabsigh R, Saikali K, Watkins V, Pullman W: Determining the earliest time within 30 minutes to erectogenic
effect after tadalafil 10 and 20 mg: A multicenter, randomized, double-blind, placebo- controlled, at-home study. J Sex Med 2004;
1(2):193-200.
TAD23
NCT00174486
Controlled trials.com
No results reported
TAD22
NCT00122499
Controlled-trials.com
No results reported
TAD23
Giuliano F, Porst H, Padma NH, Saoud J, Ferguson K, Whitaker S, Pullman W, Rosen R: Daily and on-demand IC351 treatment of
erectile dysfunction. J-Urol 2000; 163(4, Suppl.(abstract 894)):201.
Results presented as
placebo and treatment, not specified
TAD15
Giuliano F, et al. Daily IC351 treatment of erectile dysfunction. European Urology 37[suppl 2; abstract #320], 80. 2000.
per dose
Porst H, Padma-Nathan H, Giuliano F, Anglin G, Varanese L, Rosen R: Efficacy of tadalafil for the treatment of erectile dysfunction at
24 and 36 hours after dosing: a randomized controlled trial. Urology 2003; 62(1):121-125.
No data on our
selected outcomes
Porst H, Rosen RC, Padma NH, Varanese L, Anglin G, Giuliano F: Tadalafil allows men with erectile dysfunction to have successful
intercourse up to 36 hours postdose. J-Urol 2002; 167(4, Suppl.(abstract 709)):177.