Diagnosis and Treatment of Testosterone Deficiency: Recommendations from the Fourth International Consultation for Sexual Medicine (ICSM 2015)

Abstract

Introduction Testosterone deficiency (TD), also known as hypogonadism, is a condition affecting a substantial proportion of men as they age. The diagnosis and management of TD can be challenging and clinicians should be aware of the current literature on this condition. Aim To review the available literature concerning the diagnosis and management of TD and to provide clinically relevant recommendations from the Fourth International Consultation for Sexual Medicine (ICSM) meeting. Methods A literature search was performed using the PubMed database for English-language original and review articles published or e-published up to January 2016. Main Outcome Measures Levels of evidence (LoEs) and grades of recommendations are provided based on a thorough analysis of the literature and committee consensus. Results Recommendations were given for 12 categories of TD: definition, clinical diagnosis, routine measurement, screening questionnaires, laboratory diagnosis, threshold levels for the biochemical diagnosis of TD, prostate cancer, cardiovascular disease, fertility, testosterone (T) formulations, alternatives to T therapy, and adverse events and monitoring. A total of 42 recommendations were made: of these, 16 were unchanged from the Third ICSM and 26 new recommendations were made during this Fourth ICSM. Most of these recommendations were supported by LoEs 2 and 3. Several key new recommendations include the following: (i) the clinical manifestations of TD occur as a result of decreased serum androgen concentrations or activity, regardless of whether there is an identified underlying etiology [LoE = 1, Grade = A]; (ii) symptomatic men with total T levels lower than 12 nmol/L or 350 ng/dL should be treated with T therapy [LoE = 1, Grade = C]; (iii) a trial of T therapy in symptomatic men with total T levels higher than 12 nmol/L or 350 ng/dL can be considered based on clinical presentation [LoE = 3, Grade = C]; (iv) there is no compelling evidence that T treatment increases the risk of developing prostate cancer or that its use is associated with prostate cancer progression [LoE = 1, Grade = C]; and (v) the weight of evidence indicates that T therapy is not associated with increased cardiovascular risk [LoE = 2, Grade = B]. Conclusion TD is an important condition that can profoundly affect the sexual health of men. We provide guidance regarding its diagnosis and management. Men with TD who receive treatment often experience resolution or improvement in their sexual symptoms and non-sexual health benefits.

BSSM guidelines on testosterone deficiency: a summary

“…It has been BSSM guidelines on testosterone deficiency: a summary • Testosterone deficiency proposed as a genuine clinical subgroup of late-onset TD, from which some men may go on to develop overt primary TD. 9 TD may also result from impaired action of testosterone due to decreased bioavailability of the hormone (owing to variations in sex hormone binding globulin, 5 or androgen receptor changes affecting androgen activity [LoE 2, Grade A]). 5,11 It is important to remember that testosterone levels may also be suppressed by certain medications, such as oral glucocorticoids, opioids and antipsychotics.…”

“…9 TD may also result from impaired action of testosterone due to decreased bioavailability of the hormone (owing to variations in sex hormone binding globulin, 5 or androgen receptor changes affecting androgen activity [LoE 2, Grade A]). 5,11 It is important to remember that testosterone levels may also be suppressed by certain medications, such as oral glucocorticoids, opioids and antipsychotics. [12][13][14][15] Table 2 lists the factors associated with an increased prevalence of TD.…”

“…Men with TT levels <5.2nmol/L plus raised prolactin or low LH and FSH levels, should be referred to endocrinology or receive a pituitary MRI to exclude a pituitary adenoma. 5,16 Threshold laboratory values for testosterone therapy are shown in Box 2.…”

“…3,4 Currently, testosterone deficiency (TD) is defined as a clinical and biochemical syndrome, associated with advancing age and comorbidities (level of evidence [LoE] 2, Grade B). 5 The condition is characterised by a deficiency in serum androgen levels, with or without decreased genomic sensitivity to androgens, 6 and relevant signs and symptoms. 5,7 Epidemiology of TD There is wide variation in the estimated prevalence of TD.…”

“…5 The condition is characterised by a deficiency in serum androgen levels, with or without decreased genomic sensitivity to androgens, 6 and relevant signs and symptoms. 5,7 Epidemiology of TD There is wide variation in the estimated prevalence of TD. The European Male Aging study evaluated more than 3000 men between 40-79 years of age according to biochemistry and symptoms, defining the syndrome of TD as the presence of three or more sexual symptoms associated with a total testosterone (TT) level less than 11 nmol/L, and a free testosterone (FT) level less than 0.22 nmol/L.…”