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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

International Journal of Impotence Research volume 13, pages 221–229 (2001)Cite this article

Abstract

The efficacy and safety of sildenafil were evaluated in a randomised, double-blind, placebo-controlled, flexible-dose study in Taiwanese men aged 26 to 80 y with erectile dysfunction (ED) of broad-spectrum aetiology and more than 6 months' duration. A total of 236 patients were randomised at six medical centres in Taiwan to receive either sildenafil (50 mg initially increased if necessary to 100 mg or decreased to 25 mg depending on efficacy and toleration) (n=119) or matching placebo (n=117) taken on an ‘as needed’ basis 1 h prior to anticipated sexual activity for a period of 12 weeks. At the end of 12 weeks, the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse, and the secondary efficacy variables, which included: (1) the five separate domains of sexual functioning of the IIEF (International Index of Erectile Function) scale, (2) the percentage of successful intercourse attempts; and (3) a global assessment of erections, were all statistically significantly improved by sildenafil in comparison with placebo (P<0.0001). Treatment-related adverse events occurred in 43.7% of patients receiving sildenafil and 18.8% receiving placebo. The most common adverse events with sildenafil were flushing, dizziness and headache (25.2, 6.7 and 5.9% of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in the population of Taiwanese men appears similar to that reported in other studies in western populations.

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Acknowledgements

This study was supported by a grant from Pfizer.

Author information

Author notes

  1. K-K Chen, JT Hsieh, ST Huang, DB-P Jiaan, JS-N Lin and CJ Wang: See Appendix for a complete list of members of the ASSESS-3 Study Group.

Authors and Affiliations

  1. Taipei Veterans General Hospital, Taipei

    K-K Chen

  2. National Taiwan University Hospital, Taipei

    JT Hsieh

  3. Chang Gung Memorial Hospital, Taoyuan

    ST Huang

  4. Kaohsiung Veterans General Hospital, Kaohsiung

    DB-P Jiaan

  5. National Cheng Kung University Medical College, Tainan

    JS-N Lin

  6. Kaohsiung Medical University, Kaohsiung, Taiwan, Republic of China

    CJ Wang

Authors
  1. K-K Chen
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  2. JT Hsieh
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  3. ST Huang
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  4. DB-P Jiaan
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  5. JS-N Lin
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  6. CJ Wang
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Consortia

for the ASSESS-3 Study Group

Corresponding author

Correspondence to K-K Chen.

Additional information

*Asian Sildenafil Efficacy and Safety Study, #3

Appendix

Appendix

Members of the ASSESS-3 (Asian Sildenafil Efficacy and Safety Study, #3) Group in Taiwan are:

Principal investigators: Kuang-Kuo Chen, Taipei Veterans General Hospital, Taipei; Ju-Ton Hsieh, National Taiwan University Hospital, Taipei; Shih-Tsung Huang, Chang Gung Memorial Hospital, Taoyuan; Duncan Bang-Ping Jiaan, Kaohsiung Veterans General Hospital, Kaohsiung; Johnny Shinn-Nan Lin, National Cheng Kung University Medical College, Tainan; Chii-Jye Wang, Kaohsiung Medical University, Kaohsiung.

Co-investigators: Kuo Hsiung Ma, Taipei Veterans General Hospital, Taipei; Jyh-Horng Chen, Provincial Hsinchu Hospital, Hsinchu; Fong-Dee Huang, Kaohsiung Veterans General Hospital, Kaohsiung; Chun-Hsiung Huang, Kaohsiung Medical University, Kaohsiung; Yung-Ming Lin, National Cheng Kung University Hospital, Tainan.

Study coordinators: Shu-Hwei Chang, Taipei Veterans General Hospital, Taipei; Hsiu-Hsiang Lin, Chang Gung Memorial Hospital, Taipei and National Taiwan University Hospital, Taipei; Jui-Jung Wu, Kaohsiung Veterans General Hospital, Kaohsiung; Hao-Kai Chan, Kaohsiung Medical University Hospital, Kaohsiung; Yuh-Shyan Tsai, National Cheng Kung University Hospital, Tainan.

Project Management: Clinicians: Moh-Lim Ong (Taiwan), Fidela LI Moreno (Hong Kong), Mike Sweeney (New York, USA).

Support Staff: James Ng (Hong Kong), Jessica Lin, Sharon Kuo, Joyce Ya-Wen Lee, Rebecca Fang-Pin Shen (Taiwan).

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Chen, KK., Hsieh, J., Huang, S. et al. 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 13, 221–229 (2001). https://doi.org/10.1038/sj.ijir.3900685

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