The safety of available treatments of male hypogonadism in organic and functional hypogonadism

ABSTRACT

Introduction: In the case of primary male hypogonadism (HG), only testosterone (T) replacement therapy (TRT) is possible whereas when the problem is secondary to a pituitary or hypothalamus alteration both T production and fertility can be, theoretically, restored. We here systematically reviewed and discussed the advantages and limits of medications formally approved for the treatment of HG.

Areas covered: Data derived from available meta-analyses of placebo controlled randomized trials (RCTs) were considered and analyzed. Gonadotropins are well-toleratedand their use is mainly limited by higher costs and a more cumbersome treatment schedule than TRT. Available RCTs on TRT suggest that cardiovascular (CV) and venous thromboembolism risk is not a major issue and that prostate safety is guaranteed. The risk of increased hematocrit is mainly limited to the use of short terminjectable preparations.

Expert opinion: In the last few years the concept of ‘organic’ irreversible HG and ‘functional’ or age- and comorbidity-related HG has been introduced. This definition is not evidence-based. The majority of RCTs enrolled patients with ‘functional’ HG. Considering the significant improvement in body composition, glucose metabolism and sexual activity, TRT should not be limited to ‘organic’ HG, but also offered for ‘functional’.

KEYWORDS:

• Testosterone treatment
• late onset hypogonadism
• cardiovascular risk
• prostate safety
• gonadotropins

Article Highlights

• In primary male hypogonadism, only testosterone replacement therapy is possible whereas when the problem is secondary hypogonadism both T production and fertility can be theoretically, restored.

• Gonadotropins are a well-tolerated and their use is mainly limited by higher costs and more cumbersome treatment schedule than testosterone replacement therapy.

• Available data on testosterone replacement therapy suggest that cardiovascular and venous thromboembolism risk is not a major issue and that prostate safety is granted.

• The risk of increased hematocrit is mainly limited to the use of short term injectable preparations.

• Testosterone replacement therapy should not be limited to “organic” hypogonadism, but also offered to the “functional”.

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Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper has not been funded.