Evaluation of the effectiveness and safety of a daily dose of 5 mg of tadalafil, over an 8-week period, for improving quality of life among Korean men with andropause symptoms, including erectile dysfunction: A pilot study

BACKGROUND: The primary aim of this study was to evaluate the effects of a once-a-day 5 mg dose of tadalafil, prescribed for 8 weeks, on the quality of life (QoL) of South Korean men with andropause symptoms, including erectile dysfunction (ED), using a single group, open-labeled, before-and-after preliminary trial. The secondary objective was to evaluate the effectiveness and safety of tadalafil for ED. METHODS: Forty South Korean men (>35 years of age) with andropause symptoms including ED were enrolled into our trial. Andropause syndrome was defined using the androgen deficiency in aging males (ADAM) questionnaire and other screening tests, including testosterone levels. The following outcome measures were obtained at baseline and at 4 and 8 weeks of tadalafil treatment: physical examination, adverse effects, Short Form 12 Health Survey (SF-12) score, International Index of Erectile Function (IIEF-5) score, bioelectrical impedance analysis (BIA), and free radical testing. RESULTS: Treatment increased the SF-12 Mental component score, used as a proxy measure of quality of life, from baseline to at 4 and 8 weeks (P < .05). In addition, the mean IIEF-5 score, which assesses sexual function, increased from baseline at 4 and 8 weeks (P < .05), with this increase being significant at both time points. No adverse effects were noted. CONCLUSION: Tadalafil (5 mg dose, once daily) is a safe and effective treatment to improve ED, and overall QoL, among Korean men with andropause symptoms, including ED.