Efficacy and safety of testosteronein the treatment of male sexual dysfunction

ABSTRACT

Technology: Testosterone

Indication: Male sexual dysfunction

Characterization of the technology: Testosterone is a steroid hormone that is naturally produced by the testicles and in much smaller amounts by the female ovaries and adrenal glands in both sexes. Testosterone is responsible for the development and maintenance of the normal masculine characteristics, and is also extremely important for sexual function and sexual performance.

Question: Is testosterone effective and safe for treating men with sexual dysfunction?

Search and analysis of scientific evidence: The Cochrane Library (via Bireme), Medline (via Pubmed), LILACS and Centre for Reviews and Dissemination (CRD) databases were searched. We attempted to find systematic reviews of clinical trials that compared testosterone with placebo or other therapeutic option for sexual dysfunction treatment. We also searched for Health Technologies Assessments (HTA) in national and international agencies websites. Studies published in English, Portuguese or Spanish were selected.

Summary of results of selected studies: Two systematic reviews and seven randomized controlled trials were included. Thereviews showed that in men with medium to low testosterone level the use of testosterone is moderately effective. However, these reviews had low and very low quality of evidence. The included randomized clinical trials showed each one different results due to the variability between the participant’s settings in each study. In addition, many results of clinical trials did not show statistical significance. No health technology assessment was found.

Recommendations: Based on the available evidence of efficacy from the included studies, the lack of standardization in the definition of critical serum for the diagnosis of hypogonadism and the definition of appropriate dosage and the initial dose of testosterone replacement therapy, this PTC recommendation is weak in favor of the use of testosterone for the treatment of sexual dysfunction in men with hypogonadism. For men with normal testosterone levels, there is no indication for testosterone use. Of the included studies, few reported safety outcomes, therefore is not possible to conclude whether or not testosterone is safe in the treatment of sexual dysfunction in men. More studies on this subject are necessary to establish a more plausible recommendation on the use of testosterone for male sexual dysfunction treatment.

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