Late onset hypogonadism (LOH) is the most commonly used term to indicate the age-dependent reduction of testosterone.
Sexual dysfunction represents the most important determinant for medical consultation and the most specific symptoms associated with LOH. In particular, data from the European Male Ageing Study (EMAS), a population-based survey on more than 3400 subjects, recognized that a triad of sexual symptoms (low libido and reduced spontaneous and sex-related erections) is the only syndromic association with decreased testosterone levels.
Accordingly, a meta-analysis of the available randomized controlled trials documented that testosterone therapy (TTh) is able to improve all aspects of sexual function when compared to placebo.
Despite this evidence, however, the relative clinical significance and the potential benefit of TTh in LOH are still the subject of strong criticisms in the scientific community.
The debate is further complicated by the recent position statement of the US Food and Drug Administration (FDA) emphasizing a possible increased cardiovascular risk of TTh.
However, this position was not endorsed by the European Medicines Association (EMA), which reached an opposite position after a specific review of the available data. In this review, all the conflicting data supporting the different positions of the FDA and EMA will be discussed.
In particular, data derived from either population-based studies or interventional trials will be analyzed in detail. Although some evidence suggests an increase in TTh-related cardiovascular risk, the data derived from controlled trials do not support this position especially when the incidence of major adverse cardiovascular events are considered.
Symptomatic men with documented reduced testosterone levels can be safely treated with TTh.
