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Summary   Aims  Five‐α reductase inhibitor (5 ARI ) therapy has been associated with sexual dysfunction in some patients. This study assessed the impact of a fixed‐dose combination of the 5 ARI  dutasteride 0.5 mg and the α 1 ‐adrenoceptor antagonist tamsulosin 0.4 mg ( DUT ‐ TAM FDC ) on Men's Sexual Health Questionnaire ( MSHQ ) domain scores in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia ( BPH ).    Methods  This was a post hoc analysis of a double‐blind, randomised, placebo‐controlled, parallel‐group, multicentre study in sexually active patients, aged ≥50 years, with a confirmed clinical diagnosis of  BPH . Sexual activity, sexual desire, and bother domain scores of the  MSHQ  were assessed at baseline and at Months 1, 3, 6, 9, and 12. Correlation between  MSHQ  sexual activity/desire scores and ejaculation, erection, and satisfaction domains at baseline was also evaluated.    Results  In the intent‐to‐treat population (N = 489), 243 and 246 patients were randomised to  DUT ‐ TAM FDC  and placebo groups, respectively. Compared with placebo,  DUT ‐ TAM FDC  therapy resulted in statistically significant reductions (worsening) from baseline in adjusted mean  MSHQ  sexual activity and bother domain scores at Months 1, 3, 6, 9, and 12 (all  P  &lt; 0.05) and in adjusted mean  MSHQ  sexual desire domain scores at Months 6, 9, and 12 (all  P  &lt; 0.05). Significant moderate correlations in the expected direction were observed at baseline between the sexual activity/desire domains and the ejaculation, erection, and satisfaction domains ( P  &lt; 0.0001).    Conclusions  These findings help clarify the degree and impact of libido changes in sexually active men treated with  DUT ‐ TAM FDC  and may support clinical decision‐making.

international journal of clinical practice

Evaluation of the impact of dutasteride/tamsulosin combination therapy on libido in sexually active men with lower urinary tract symptoms ( LUTS ) secondary to benign prostatic hyperplasia ( BPH ): A post hoc analysis of a prospective randomised placebo‐controlled study