Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Paper
  • Published:

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

International Journal of Impotence Research volume 13, pages 192–199 (2001)Cite this article

Abstract

Vardenafil, a novel selective phosphodiesterase type 5 inhibitor, was evaluated in its first large-scale at-home trial. A total of 601 men with mild to severe erectile dysfunction (ED) were enrolled in this multi-centre, randomized, double-blind, placebo-controlled trial of 12 weeks of treatment with either placebo or 5, 10 and 20 mg of vardenafil. Primary endpoints were Q3 (vaginal penetration) and Q4 (maintenance of erection) of the International Index of Erectile Function (IIEF). In the intent-to-treat population (n=580), the changes from baseline for 5, 10 and 20 mg vardenafil (1.2, 1.3 and 1.5, respectively) were all improved (P<0.001) over placebo (0.2) for Q3 and were similarly improved for Q4 (1.4, 1.5 and 1.7) compared to placebo (0.5) (P<0.001). All vardenafil doses improved all IIEF domains compared to placebo (P<0.001). The percentage of successful intercourses was between 71 and 75% for the three vardenafil doses. For the 20 mg dose, 80% of the patients experienced improved erections (GAQ) compared to 30% for placebo. Most frequent treatment-emergent adverse events were headache (7–15%), flushing (10–11%) and up to 7% for dyspepsia or rhinitis. Vardenafil treatment resulted in a high efficacy and low adverse-event profile in a population with mixed ED etiologies.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

Similar content being viewed by others

References

  1. Braun M et al. Die Prävalenz von männlichen Erektionsstörungen in Deutschland heute und in der Zukunft. Akt Urol 2000 31, 302–307

    Article  Google Scholar 

  2. Koskimaki J, Hakama M, Huhtala H, Tammela TL . Effect of erectile dysfunction on frequency of intercourse: a population based prevalence study in Finland. J Urol 2000 164, 367–370

    Article  CAS  Google Scholar 

  3. Glasser D, Sweeney M . The prevalence of erectile dysfunction in four countries: Italy, Brazil, Malaysia and Japan. Poster presented at 1st International Consultation on Erectile Dysfunction, Paris, 1–3 July 1999

  4. Feldman H et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994 151, 54–61

    Article  CAS  Google Scholar 

  5. Chew K et al. Erectile dysfunction in general medicine practice: prevalence and clinical correlates. Int J Impot Res 2000 12, 41–45

    Article  CAS  Google Scholar 

  6. Johannes CB et al. Incidence of erectile dysfunction in men 40 to 69 y old: longitudinal results from the Massachusetts Male Aging Study. J Urol 2000 163, 460–463

    Article  CAS  Google Scholar 

  7. Willke R et al. Quality of life effects of alprostadil therapy for erectile dysfunction: results of a trial in Europe and South Africa. Int J Impot Res 1998 10, 239–246

    Article  CAS  Google Scholar 

  8. Wagner T, Patrick D, McKenna S, Froese P . Cross-cultural development of a quality of life measure for men with erection difficulties. Qual Life Res 1996 5, 443–449

    Article  CAS  Google Scholar 

  9. Nied R, Penson DF, Dhanani N, Litwin MS . Effect of erectile dysfunction on health-related quality of life. J Urol 1997 157(Suppl 4), 427

    Google Scholar 

  10. Jain S, Bhojwani A, Terry TR . The role of penile prosthetic surgery in the modern management of erectile dysfunction. Postgrad Med J 2000 76, 22–25

    Article  CAS  Google Scholar 

  11. Porst H . Current perspectives on intracavernosal pharmacotherapy for erectile dysfunction. Int J Impot Res 2000 12(Suppl 4), S91–S100

    Article  Google Scholar 

  12. Montague DK et al. Clinical guidelines panel on erectile dysfunction: summary report on the treatment of organic erectile dysfunction. J Urol 1996 156, 2007–2011

    Article  CAS  Google Scholar 

  13. Ignarro LJ et al. Nitric oxide and cyclic GMP formation upon electrical field stimulation cause relaxation of corpus cavernosum smooth muscle. Biochem Biophys Res Commun 1990 170, 843–850

    Article  CAS  Google Scholar 

  14. Burnett AL . Role of nitric oxide in the physiology of erection. Biol Reprod 1995 52, 485–489

    Article  CAS  Google Scholar 

  15. Burnett A . Nitric oxide in the penis: physiology and pathology. J Urol 1997 157, 320–324

    Article  CAS  Google Scholar 

  16. Christ GJ, Richards S, Winkler A . Integrative erectile biology: the role of signal transduction and cell-to-cell communication in coordinating corporal smooth muscle tone and penile erection. Int J Impot Res 1997 9, 69–84

    Article  CAS  Google Scholar 

  17. Sullivan ME et al. Nitric oxide and penile erection: is erectile dysfunction another manifestation of vascular disease? Cardiovasc Res 1999 43, 658–665

    Article  CAS  Google Scholar 

  18. Jeremy JY et al. Effects of sildenafil, a type-5 cGMP phosphodiesterase inhibitor, and papaverine on cyclic GMP and cyclic AMP levels in the rabbit corpus cavernosum in vitro Br J Urol 1997 79, 958–963

    Article  CAS  Google Scholar 

  19. Padma-Nathan H, Steers WD, Wicker PA, and the Sildenafil Study Group . Efficacy and safety of oral sildenafil in the treatment of erectile dysfunction: a double-blind, placebo-controlled study of 329 patients. Int J Clin Pract 1998 52, 375–379

    CAS  Google Scholar 

  20. Morales A et al. Clinical safety of oral sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction. Int J Impot Res 1998 10, 69–73

    Article  CAS  Google Scholar 

  21. Langtry HD, Markham A . Sildenafil: a review of its use in erectile dysfunction. Drugs 1999 57, 967–989

    Article  CAS  Google Scholar 

  22. Goldstein I et al. Oral sildenafil in the treatment of erectile dysfunction. New Engl J Med 1998 338, 1397–1404

    Article  CAS  Google Scholar 

  23. Porst H . The management of erectile dysfunction in the elderly with Sildenafil (Viagra™)—Results of a prospective trial in 823 patients. Aging Male 2000 3(Suppl 1), 92

    Google Scholar 

  24. Bischoff E, Schneider K . A conscious rabbit model is able to demonstrate the efficiacy of vardenafil and sildenafil on penile erection. Int J Impot Res 2000 12(Suppl 3), 65

    Google Scholar 

  25. Klotz T et al. Vardenafil increases penile rigidity and tumescence in erectile dysfunction patients: a RigiScan and pharmacokinetic study. World Urol 2001 19, 32–39

    Article  CAS  Google Scholar 

  26. Stark S, et al. Erectile response on visual sexual stimulation after 20 mg or 40 mg BAY 38-9456 or placebo. Eur Urol 2000 37(Suppl 2), 4 abstract 15

    Google Scholar 

  27. Rosen RC, et al. The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997 49, 822–830

    Article  CAS  Google Scholar 

  28. Fugl-Meyer A, Lodnert G, Branholm I, Fugl-Meyer K . On life satisfaction in male erectile dysfunction. Int J Impot Res 1997 9, 141–148

    Article  CAS  Google Scholar 

  29. Cappelleri JC et al. Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function. Urology 1999 54, 346–351

    Article  CAS  Google Scholar 

  30. Bischoff E, Niewoehner U, Haning H . Vardenafil a potent and selective inhibitor of phosphodiesterase type 5 increases cGMP in rabbit corpus cavernosum. Int J Impot Res 2000 12(Suppl 3), 65

    Google Scholar 

Download references

Acknowledgements

We would like to thank John Firrell, PhD for his assistance in preparing this manuscript and all the investigators, site coordinators and clinical trial managers who helped make this study possible.

Vardenafil Study Group (alphabetical within each country)

Belgium: Duyck F, Merckx L.

France: Buvat J, Cuzin BACV, Fourcade R, Giuliano F, Sarramon JP.

Germany: Emrich HM, Grohmann W, Lenk VS, Nietzsch DH, Porst H, Szymula S, Vilmar W.

The Netherlands: Asscheman H, Kropman RF, Lycklama GA, Nijeholt, AAB.

Poland: Borkowski A, Krajka K.

Republic of South Africa: Mackenzie TM, Robertson LI, Schmidt AC, Sleep DJ, Wing JR, Feldman RA.

USA: Auerbach SM, Garland WT, Gleason DM, Harris RG, Kaufman JM, Klimberg IW, Padma-Nathan H, Rosen RC, Sharp SC, Smith WB, Steidle CP, Storrie MC, White CF, Young JM.

Author information

Authors and Affiliations

  1. Urological Practice, Hamburg, Germany

    H Porst

  2. University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Piscataway, NJ, USA

    R Rosen

  3. Keck School of Medicine, University of Southern California, Beverly Hills, CA, USA

    H Padma-Nathan

  4. Department of Urology, Boston University Medical School, Boston, MA, USA

    I Goldstein

  5. Department of Urology, CHU de Bicêtre, AP-HP, Medical University of Paris South, Le Kremlin Bicêtre and Hopital Salvator, Marseille, France

    F Giuliano

  6. Bayer Vital, Leverkusen, Germany

    E Ulbrich

Authors
  1. H Porst
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. R Rosen
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. H Padma-Nathan
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. I Goldstein
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. F Giuliano
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. E Ulbrich
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

T Bandel and the Vardenafil Study Group

Corresponding author

Correspondence to H Porst.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Porst, H., Rosen, R., Padma-Nathan, H. et al. 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 13, 192–199 (2001). https://doi.org/10.1038/sj.ijir.3900713

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/sj.ijir.3900713

Keywords

This article is cited by

Search

Advanced search

Quick links