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A baseline-controlled, open-label, flexible dose-escalation study to assess the safety and efficacy of sildenafil citrate (Viagra®) in patients with erectile dysfunction

International Journal of Impotence Research volume 15, pages S19–S24 (2003)Cite this article

Abstract

Although sildenafil citrate (Viagra®) has demonstrated effectiveness in the treatment of erectile dysfunction (ED), the dosing regimens often used in clinical trials may not always match those employed in clinical practice. This study was undertaken to further assess the efficacy and safety of sildenafil taken as required in male outpatients 18 years of age and older with ED (n=71). It was conducted as a placebo-baseline–controlled, open-label, flexible dose-escalation study, with sildenafil (25,50, or 100 mg) administered for 8 weeks following a 4-week placebo run-in. Efficacy variables included questions 3 and 4 of the International Index of Erectile Function (IIEF), other IIEF domains, patient event logs, and quality-of-life (QOL) assessments. Treatment with sildenafil resulted in improvements from baseline in all IIEF domains analyzed (all P<0.0001), as well as overall QOL and amelioration of specific sexual and social relationships (all P<0.0001). Sildenafil was well tolerated. One participant discontinued treatment because of adverse events. Results suggest that flexible dosing with oral sildenafil is safe and has beneficial effects on all indices of erectile function and QOL.

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Acknowledgements

This study was supported by a research grant from Pfizer Inc.

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Authors and Affiliations

  1. Department of Urology, Ibn Sina University Hospital, Rabat, Morocco

    A Benchekroun & M Faik

  2. Department of Urology, Ibn Rochd University Hospital, Casablanca, Morocco

    S Benjelloun, S Bennani & M El Mrini

  3. Urology & Andrology Center, Abou Abdellah Nafii, Casablanca, Morocco

    A Smires

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  1. A Benchekroun
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Benchekroun, A., Faik, M., Benjelloun, S. et al. A baseline-controlled, open-label, flexible dose-escalation study to assess the safety and efficacy of sildenafil citrate (Viagra®) in patients with erectile dysfunction. Int J Impot Res 15 (Suppl 1), S19–S24 (2003). https://doi.org/10.1038/sj.ijir.3900969

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