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Endocrine society clinical practice guidelines hypogonadism male: Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline

FT measurements by direct tracer analog immunoassays are frequently available in local and some reference laboratories, but these direct immunoassays are inaccurate and should not be used 23 , The European Medicines Agency concluded that there is no consistent evidence of an increased risk of coronary heart disease associated with T therapy in hypogonadal men

Matthew Cox
Friday, October 2, 2020
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  • Table 8 lists the adverse effects associated with the use of specific T formulations.

  • T directly stimulates bone formation and inhibits bone resorption through multiple mechanisms that involve estrogen receptor— and androgen receptor—mediated processes 14 Cardiovascular risks and elevation of serum DHT vary by route of testosterone administration: a systematic review and meta-analysis.

  • We strongly believe the former to be the case.

Summary of Recommendations

Researchers observed no statistically significant difference in endocrine society clinical practice guidelines hypogonadism male or mood. Requires surgical incision for insertions; pellets may extrude spontaneously; rarely, local hematoma and infection may occur. In men who have not undergone complete pubertal development, T therapy induces the development of secondary sex characteristics, including facial and body hair growth, deepening of the voice, muscle and bone accretion, penile enlargement, and pigmentation of the scrotum T therapy increases the risk of detecting subclinical prostate cancer because of increased surveillance and T-induced increase in PSA levels, which may lead to increased risk of prostate biopsy

Cardiovascular risks of exogenous testosterone use among men: a systematic review and meta-analysis. Adequacy of androgen replacement influences bone density response to testosterone in androgen-deficient men. Clinical review: endogenous testosterone and mortality in men: a systematic review and meta-analysis. Testosterone replacement increases fat-free mass and muscle size in hypogonadal men. Nevertheless, whether for MH or TDS, the basic diagnostic criteria across all guidelines are broadly similar, including a combination of clinical symptoms with biochemical evidence of low T, plus an impact on physical health and wellbeing. The commissioned meta-analysis showed that T treatment was associated with a significantly higher frequency of erythrocytosis vs placebo.

  • Regarding the fourth category defects in androgen target organswhilst partial and incomplete forms of androgen-insensitivity due to androgen receptor AR mutations are increasingly recognized in infertile men [ 32 ], evidence for high-dose testosterone being able to surmount these defects is currently slim [ 33 ].

  • Financial Support: This guideline was supported by the Endocrine Society. J Clin Endocrinol Metab ; 90 3 : —

  • Endocr Rev.

  • Eur J Endocrinol. Restores serum T, DHT, and E2 concentrations to the physiological male range; absorbed from the buccal mucosa.

  • Association of specific symptoms and metabolic risks with serum testosterone in older men.

In men determined to have androgen deficiency, we recommend additional diagnostic evaluation to ascertain the cause of androgen deficiency. T concentrations may be affected by acute illness, nutritional deficiency, and by certain medications e. T therapy increases the risk of detecting subclinical prostate cancer because of increased surveillance and T-induced increase in PSA levels, which may lead to increased risk of prostate biopsy Testosterone replacement increases fat-free mass and muscle size in hypogonadal men.

Osteoporosis in men: an Endocrine Society clinical practice guideline. There was no significant difference in the change in lower urinary tract symptoms mean difference, 0. Diabetes in myotonic dystrophy. Physicians should recognize that there is considerable disagreement among experts on this issue due to incomplete evidence. For instance.

Publication types

J Clin Endocrinol Metab ; 90 3 : — Receive exclusive offers and updates from Oxford Academic. Mayo Clin Proc. Clomiphene citrate has been used empirically in men with hypogonadotropic hypogonadism; however, neither its efficacy nor its safety has been demonstrated in randomized trials.

Primary hypogonadism results in low T concentrations, impairment of spermatogenesis, and elevated gonadotropin levels. Author information Article xociety Copyright and License information Disclaimer. In contrast testosterone treatment is not generally recommended by ES or AUS for the other category of men having intrinsically intact HPT axis, but suppressed function due to other causes e. Therefore, it is important to measure T concentrations in the patient group once a steady-state has been achieved.

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Conditions that lower SHBG [ e. Fertility options for men with primary testicular failure are limited to the use of donor sperm, adoption, or in some patients assisted reproductive technologies, such as intracytoplasmic sperm injection using pgactice in the ejaculate or following testicular sperm extraction. Fuidelines IM injection; peaks and valleys in serum T concentrations that may be associated guidelines hypogonadism male fluctuations in symptoms. The ES considers advanced age to be a cause of organic PH, but not a cause of organic HH, whereas AUS does not consider age to cause any form of MH and does not necessarily consider a raised LH level in an older man as indicating pathological MH meritorious of testosterone treatment. Also, a man with a missense mutation of the SHBG gene who had complete deficiency of SHBG and very low TT concentrations was reported to have normal FT and gonadotropin levels, normal male reproductive development, and normal testes size and spermatogenesis, suggesting a limited role of SHBG in male sexual development and spermatogenesis Current case-finding instruments for detecting testosterone deficiency lack sufficient sensitivity and specificity to be useful for screening men who are receiving health care for unrelated reasons.

If this email is not correct, please update your settings with your correct address. Variable clinical responses; administration with fatty meal is required; fat content of meals affects bioavailability; variable serum T concentrations, high DHT:T ratio. Systemic illness a. Int J Clin Pract.

J Clin Psychopharmacol. Managing the risks of prostate disease during testosterone replacement therapy in older men: recommendations for a standardized monitoring plan. It is also possible that T administration may cause subclinical prostate cancers which mald have been present before but were undetected to grow socuety T administration and become clinically overt. Support for the free hormone hypothesis has come from a recent analysis of the European Male Aging Study data, which showed that compared to middle-aged and older men who had normal TT and FT concentrations men with low FT concentrations had sexual and physical symptoms consistent with T deficiency, regardless of their TT concentrations Linked to each recommendation is a description of the evidence and the values that the task force considered in making the recommendation; in some instances, there are remarks, a section in which the task force offers technical suggestions for testing conditions, dosing, and monitoring. We recommend T therapy for men with symptomatic T deficiency to induce and maintain secondary sex characteristics and correct symptoms of hypogonadism after discussing the potential benefits and risks of therapy and of monitoring therapy and involving the patient in decision making. Testosterone and Aging: Clinical Research Directions.

The cost-effectiveness of measuring BMD and the frequency at which it should be performed are not known. Cochrane Database Syst Rev. Most guidelines acknowledge that HH can arise due to legitimate or illegitimate use of prescription medications e. The relative contributions of aging, health, and lifestyle factors to serum testosterone decline in men.

  • We strongly believe the former to be the case.

  • Explain the potential benefits and risks of monitoring for prostate cancer and engage the patient in shared decision making regarding the prostate monitoring plan. Anabolic steroid induced hypogonadism in young men.

  • The Endocrine Society maintains a rigorous conflict-of-interest review process for developing clinical practice guidelines.

  • Ideally, case detection should identify those patients who seek medical attention for one or more medical problems who are at sociery risk of having hypogonadism and likely to benefit from T therapy. In the Testosterone Trials TTrials which we describe in greater detail later in this articleno statistically significant improvement was observed in fatigue with T treatment vs placebo 68 ; this was confirmed in the commissioned systematic review and meta-analysis.

An approach for the diagnostic evaluation of adult men suspected of endocrine society clinical practice guidelines hypogonadism male T deficiency. T therapy increases the risk of detecting subclinical prostate cancer because of increased surveillance and T-induced increase in PSA levels, which may lead to increased risk of prostate biopsy Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. Prevalence of hypogonadism among men with weight loss related to human immunodeficiency virus infection who were receiving highly active antiretroviral therapy. The project cross-calibrated the assays used for each cohort against a higher order method and calibrator developed by the CDC and then harmonized the local values to the CDC-standardized measurements Potentially reversible functional causes of secondary hypogonadism are listed in Table 1.

J Bone Miner Metab. Furthermore, many have been prescribed testosterone without any prior testing of serum T level, or even more worryingly with normal initial T level [ 1617 ]. This should start at age 40 in men who are at increased risk for high-grade cancers, such as African Americans and men with a first-degree male relative with diagnosed prostate cancer. We hope this review will allow clinicians to navigate the field of MH with greater confidence and, thereby, offer the most appropriate and safe advice and management subject to limitations of the existing evidence base.

Other studies suggest that men with erectile dysfunction and low T may have an increased risk of cardiovascular disease and all-cause mortality, but we cannot infer a causal association Overall, short-term 3 to 6 months T use in HIV-infected guidelijes with low T concentrations and weight loss can lead to small gains in body weight, LBM, and mood, with minimal change in quality of life. Specific symptoms and signs. When the goal of treatment is to replace T, treating men with prepubertal onset of hypogonadism is similar to treating men with postpubertal onset hypogonadism, although some practitioners and patients may elect to start T treatment at a lower dosage initially and gradually increase the dose over many months to avoid sexually disturbing thoughts.

Table 6. Most clinical laboratories measure LH and FSH levels using immunometric assays that have sufficient sensitivity to hypogoonadism between normal and low levels. Transdermal patches: assess T concentrations 3—12 h after application; adjust dose to achieve T concentration in the mid-normal range. Risk of venous thromboembolism in men receiving testosterone therapy. Chapter, Classification of hypothalamic-pituitary-gonadal HPG axis endocrine disorders.

Estimates of FT that use an allosteric model provide close approximations of levels measured using equilibrium dialysis. A Cochrane review also found greater clinival and LBM gains in men assigned to androgens than in those assigned to placebo arms of RCTs Testosterone increased guidelines hypogonadism male bone mineral density and the estimated bone strength of the spine and hip. First do no harm. In these trials, T treatment consistently increased LBM and vertebral BMD and decreased fat mass, but the effects on muscle strength, physical function, femoral bone density, sexual function, energy, and mood were variable. Endogenous sex hormones and prostate cancer: a collaborative analysis of 18 prospective studies. Hence, questions of diagnostic specificity apply to EMAS and many other studies that describe populations of older, obese men with slightly low T levels as having adult-onset HH.

INTRODUCTION

Adverse events for which there is evidence of association with T administration. Primary Care Written by. Causes of hypogonadism may be organic or practice guidelines, a distinction that has important clinical implications Table 1. Consequently, they recommend systematic screening for MH in those clinical settings, even in the absence of symptoms or signs, which is a radical and potentially resource-intense departure from traditional case-finding practice. The ES sensibly recommends only considering T treatment of opiate-induced hypogonadism in men with distressing symptoms and in whom opiate-withdrawal is not an option.

Diabetes Care ;— TT concentrations are measured using radioimmunoassay, immunometric assays, or liquid chromatography—tandem mass spectrometry. Endocrine society clinical practice guidelines hypogonadism male suggest that when clinicians institute T therapy, they aim at achieving T concentrations in the mid-normal range during treatment with any of the approved formulations, taking into consideration patient preference, pharmacokinetics, formulation-specific adverse effects, treatment burden, and cost. Furthermore, a small fraction of hypogonadal men develop supraphysiologic T concentrations with intramuscular T and may be susceptible to dose-related adverse effects. Other studies suggest that men with erectile dysfunction and low T may have an increased risk of cardiovascular disease and all-cause mortality, but we cannot infer a causal association

  • The AUS offers a similar definition, and both guidelines exhaustively detail the sub-classification and differential diagnosis of MH.

  • Frequent occurrence of hypogonadotropic hypogonadism in type 2 diabetes.

  • In men deemed to have secondary hypogonadism, additional diagnostic evaluations may be needed to exclude hyperprolactinemia, head trauma, iron overload syndromes, hypothalamic or pituitary tumors, and other infiltrative or destructive hypothalamic—pituitary diseases, as well as genetic disorders associated with gonadotropin deficiency.

Low free testosterone is associated with hypogonadal signs and symptoms in men mals normal total testosterone. Article Navigation. Parallel-group placebo-controlled trial of testosterone gel in men with major depressive male displaying an incomplete response to standard antidepressant treatment. There have been no RCTs that were large enough or long enough to determine the effects of T-replacement therapy on major adverse cardiovascular events MACE. The project cross-calibrated the assays used for each cohort against a higher order method and calibrator developed by the CDC and then harmonized the local values to the CDC-standardized measurements

T alone is required to maintain lean mass and muscle size and strength; estradiol is required to prevent increases in fat mass and vasomotor symptoms, and both T and estradiol are required to maintain sexual function and bone mineral density BMD 13 Klinefelter syndrome: integrating genetics, neuropsychology, and endocrinology. The recommendation not to treat asymptomatic older men with age-related declines in T concentration places a higher value on avoiding unknown long-term risks and a lower value on the limited evidence of the potential benefits of T therapy. Am J Med.

Summary of Recommendations

Men who have prepubertal onset of hypogonadism practice guidelines hypogonadism is not adequately treated will exhibit eunuchoidal proportions, lack of development of secondary sex characteristics, and high-pitched voice eunuchodism 56. Sex steroid hormones and the androgen receptor gene CAG repeat and subsequent risk of prostate cancer in the prostate-specific antigen era. The mechanism of cough, which has been reported rarely after intramuscular injections of T undecanoate and even more rarely after T enanthate and cypionate, is unknown, but it has been attributed to pulmonary oil microembolization.

Evidence: This evidence-based guideline was developed guideilnes the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. More than one sample is required for diagnostic purposes and, if so, what the minimum spacing between samples should be? J Applied Lab Med. J Am Coll Cardiol. J Am Coll Cardiol.

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Am Lose weight drinking diet green tea Psychiatry. Detailed analysis of TTT is beyond the scope of this review, but their hjpogonadism can be summarised as follows in respect of older men with obesity and metabolic syndrome: Testosterone was marginally more effective than PDE5-inhibitors in respect of sexual functioning; albeit any superiority may not last beyond a year from initiation. Therefore, clinicians should use a reliable reference laboratory for these tests. J Urol. J Thromb Haemost. Subtherapeutic T concentrations may contribute to poor efficacy and high treatment discontinuation rates. Causes of hypogonadism may be organic or functional, a distinction that has important clinical implications Table 1.

Guidelines hypogonadism male studies suggest that men with erectile dysfunction and low T may have an increased risk of hyopgonadism disease and all-cause mortality, but we cannot infer a causal association The fall in T concentrations with age is gradual, and varies in different individuals with higher rates of decline in men with adiposity and comorbid diseases 12, Obesity, diabetes, or metabolic syndrome are perceived as increasing the pre-test probability of MH, or conversely, acting to reduce the diagnostic specificity of a low serum T level and increasing the possibility of NGI causing biochemical phenocopy of HH? SMD of 0.

T therapy in healthy hypogonadal men increases areal and volumetric vertebral and femoral Endocrinf and vertebral and femoral bone strength 69—71but there are no studies on the effects of T on fracture risk. Abstract Objective. Am J Physiol Endocrinol Metab. Some men may develop a new prostate cancer unrelated to T treatment.

TAKE-HOME MESSAGE

Although OSA and sleep disorders are nypogonadism with increased risk of low T concentrations, the frequency of OSA in randomized T trials has been very low. In hypogonadal men being considered for testosterone therapy who are 40 to 69 years old and at increased risk of prostate cancer e. Endocrine Society committees and members and the cosponsoring organization were invited to review and comment on preliminary drafts of the guideline. Evaluate formulation-specific adverse effects at each visit as per Table 5.

  • The review identified 11 reports of four trials with participants. Causes of secondary hypogonadism include hyperprolactinemia; severe obesity; iron overload syndromes; the use of opioids, glucocorticoids, or androgen-deprivation therapy with gonadotropin-releasing hormone agonists; androgenic—anabolic steroid AAS withdrawal syndrome; idiopathic hypogonadotropic hypogonadism; hypothalamic or pituitary tumors or infiltrative disease; head trauma; and pituitary surgery or radiation.

  • Serum TT concentration represents the sum of unbound and protein-bound T in circulation.

  • Indeed, there are persisting concerns relating to CV disease that may relate to a counterbalancing risk arising from greater propensity to arterial thrombosis with rising hematocrit.

  • J Sex Med. Table 9.

Diagnosis and management of anabolic androgenic steroid use. The contraindications clinical practice treatment are outlined. To avoid testosterone-induced erythrocytosis, many guidelines counsel against initiating T in patients with baseline elevated Hct, which makes sense in terms of mitigating CV risk. The symptoms and signs of T deficiency are nonspecific and modified by age, comorbid illness, severity and duration of T deficiency, variations in androgen sensitivity, and previous T therapy. Local laboratories usually do not have accurate and reliable assays for FT measurement.

Harmonized reference ranges for circulating testosterone levels in men of four cohort studies in the United States and Europe. Testosterone replacement therapy improves mood in hypogonadal men—a endocrine society clinical practice guidelines hypogonadism male research center study. Data about cognition and bone mineral density were only available in one trial, which reported no significant improvement in measures of cognition but did report improvements in areal and volumetric bone mineral density and bone strength in the spine and hip. At least two T measurements were needed to diagnose T deficiency with confidence 9 ,

The Endocrine Society makes hupogonadism warranty, express or implied, regarding the guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose. Pellets containing — mg T implanted SC; the number of pellets and the regimen may vary with formulation. Clinicians should not administer testosterone therapy to men with baseline hematocrit above the upper limit of normal for the laboratory without discussing the potential for an increased risk of erythrocytosis and the need to monitor hematocrit assiduously. For many other chronic diseases, patients are increasingly contributing to guidance, but with notable exceptions [ 61 ] the patient experience of treatment in MH—frequently preceded by a prolonged diagnostic odyssey—is not well-represented in guidance.

The commissioned meta-analysis showed endocrine society clinical practice guidelines hypogonadism male T treatment was associated with a significantly higher frequency of erythrocytosis vs placebo. T therapy suppresses spermatogenesis and is not appropriate in men with hypogonadotropic hypogonadism who desire fertility in the next 6 to 12 months. The CMAJ recommends a therapeutic target of A survey of 3, middle aged men age 40—79 years [ 59 ]. We have detected that you are using an Ad Blocker. J Thromb Haemost. In exploring the major differences and similarities in their respective recommendations, we highlight how these variations might differentially impact clinical practice and discuss the therapeutic and pharmaco-economic implications thereof.

Clin Appl Thromb Hemost. Mol Cell Endocrinol. Multiple cljnical intranasal dosing required; local nasal side effects, not appropriate for men with nasal disorders. For laboratories that are not CDC certified and do not participate in an accuracy-based quality control program, the reference range may vary considerably depending on the assay and reference population used.

Hypogonadixm of spermatogenesis by gonadotropins in men with hypogonadotropic hypogonadism. Explain the potential benefits and risks of monitoring for prostate cancer and engage the patient in shared decision making regarding the prostate monitoring plan. Effects of testosterone replacement on muscle mass and muscle protein synthesis in hypogonadal men—a clinical research center study.

We recommend confirming the diagnosis by repeating the measurement of morning fasting total T concentrations. Summary statement on screening for prostate cancer in Europe. Clin Endocrinol Oxf ; 79 — Outside the United States, oral T undecanoate and a matrix transdermal T patch are available for clinical use in many countries; physicians should follow the drug regimens approved in those countries. Conditions that are associated with decreased SHBG concentrations. Endocr Rev.

Similar unjustified trends in testosterone prescribing were observed in Australia over a year period [ 19 ]. Testicular disorders. Diagnosis and management of anabolic androgenic steroid use. This situation is unlikely to improve as long as guidelines continue to display markedly heterogenous recommendations in major area of clinical practice, including: Basic terminology: whether to remain with MH, or move to a new descriptor, TDS? Articles from Endocrinology and Metabolism are provided here courtesy of Korean Endocrinology Society.

  • Prostate Cancer Prevention Trial risk calculator 2.

  • Men receiving methadone maintenance therapy are at high risk of developing opioid-induced hypogonadism, whereas the prevalence of opioid-induced hypogonadism is substantially lower with buprenorphine.

  • After a single IM injection, serum T concentrations rise into the supraphysiological range, then decline gradually into the hypogonadal range by the end of the dosing interval. Int J Cancer.

  • Serum T concentrations exhibit a diurnal variation with peak values in the morning; aging reduces the magnitude of this diurnal variation The guidelines cannot guarantee any specific outcome, nor do they establish a standard of care.

The frequency of neuro-occlusive events in men with hypogonadism societg in RCTs of T who developed erythrocytosis has been very low. There is considerable variation in T concentrations in hypogonadal men who are receiving T therapy 8; this variation is even greater in hypogonadal men being treated with transdermal gels or with oral T undecanoate. Permissions Icon Permissions. T therapy does not improve depressive symptoms in men with clinical depression The review only included trials that used testosterone or its esters.

Prognostic endocrine society clinical practice guidelines hypogonadism male of digital rectal examination and prostate specific antigen in the prostate, lung, colorectal and ovarian PLCO cancer screening arm. Therefore, clinicians should confirm PSA elevations by repeating the test. The recommendation to offer T therapy to healthy hypogonadal men places a higher value on alleviating symptoms of T deficiency and achieving the other benefits of T therapy and a lower value on avoiding the potential burden of long-term treatment, monitoring, cost, and the unclear long-term safety of T therapy. Very high risk of serious adverse outcomes.

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Clinicians should not hypotonadism direct analog-based free testosterone immunoassays, as pracctice are inaccurate. Harmonized reference ranges for circulating testosterone levels in men of four cohort studies in the United States and Europe. The baseline assessment of prostate cancer risk should consider risk factors, such as age, family history increased risk in men having a first-degree relative with prostate cancerrace increased risk in African Americansprior biopsy history, elevated PSA levels, and positive prostate examination results. Spermatogenesis can be stimulated and fertility can be restored with appropriate gonadotropin therapy in patients with secondary hypogonadism but not in patients with primary hypogonadism. The suggestion not to treat asymptomatic men with T2DM places a lower value on the unproven potential benefits of T therapy with regard to glycemic control and a higher value on avoiding the burdens of T administration, monitoring, and cost, as well as the unknown long-term risks of T therapy.

  • Pellets containing — mg T implanted SC; the number of pellets and the regimen may vary with formulation. Retrospective analyses of data using electronic medical records have also been inconclusive and are similarly constrained by the lack of randomized allocation and prospective adjudication of cardiovascular events, confounding by indication, and heterogeneity of patient populations, T doses, and intervention durations 96—

  • The European Medicines Agency concluded that there is no consistent evidence of an increased risk of coronary heart disease associated with T therapy in hypogonadal men

  • Skip Nav Destination Article Navigation.

Similar endocrine society clinical practice guidelines hypogonadism male of men in both treatment groups experienced MACE during the year of treatment or the subsequent year of observation. Conditions that lower SHBG [ e. Provides flexibility of dosing, ease of application, good skin tolerability; less erythrocytosis than injectable T. Local laboratories usually do not have accurate and reliable assays for FT measurement. The task force formulated evidence-based recommendations following the approach recommended by the Grading of Recommendations, Assessment, Development, and Evaluation Group, an international committee with expertise in the development and implementation of evidence-based guidelines 1. Adverse events associated with testosterone administration.

Requires IM injection of a large volume 3 or 4 mL ; coughing episode reported immediately after injection in a small number of men. Table 2. Clinicians should not test men for testosterone deficiency endocrine society clinical practice guidelines hypogonadism male have or are recovering from an acute illness or are engaged in short-term use of medications e. As testosterone therapy is not without risk several clinical practice guidelines have been published specialist societies to guide physicians on best practice. The evidence from these trials warranted moderate and high certainty, respectively, in the provided estimates. Hormonal predictors of prostate cancer: a meta-analysis. At least two T measurements were needed to diagnose T deficiency with confidence 9 ,

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Prevalence of symptomatic androgen deficiency in men. If this email is not correct, please update your settings with your correct address. Testosterone was marginally more effective than PDE5-inhibitors in respect of sexual functioning; albeit any superiority may not last beyond a year from initiation. Injectable T undecanoate: measure serum T levels at the end of the dosing interval just prior to the next injection and aim to achieve nadir levels in low-mid range. Treatment with medications that affect T production or metabolism, such as opioids and glucocorticoids.

Testosterone replacement therapy improves insulin resistance, glycaemic control, visceral adiposity and hypercholesterolaemia in hypogonadal men with type 2 diabetes. Testosterone therapy in patients with treated and untreated prostate cancer: impact on oncologic outcomes. Effects of testosterone treatment in older men. Bulliard J-LChiolero A. Intriguingly, men with PH have a 3 to 4-fold relative risk of having T2DM, whether related to ageing [ 11 ], Klinefelter syndrome [ 14 ], or myotonic dystrophy [ 15 ]. Table 8 lists the adverse effects associated with the use of specific T formulations.

An important objective of the baseline evaluation in men being considered for T-replacement therapy cclinical to identify and exclude those who have a history of prostate cancer endocrine society clinical practice guidelines hypogonadism male are at high risk for developing prostate cancer. However, EMAS also found the overwhelming contribution to the apparent age-related decline in T levels to reside not in chronological oractice per sebut rather in the accumulation of age-associated co-morbidities, such as obesity, resulting in suppression of LH secretion [ 8 ]. The EUA acknowledges a lack of data to define an optimal therapeutic target, but their expert consensus suggests aiming for the mid-normal age-adjusted range, or whatever level alleviates symptoms. Commissioned Systematic Review. The ES recommends case detection for men deemed to be at increased risk of having hypogonadism and likely to benefit from T therapy, such as those with low libido, erectile dysfunction, infertility, HIV-associated weight loss, osteoporosis or low-trauma fracture, a history of anabolic steroids use, or using opioids or other drugs or substances that affect T production or metabolism. Clinicians should also measure FT in men whose serum TT concentration is modestly above or below the lower limit of normal e.

We recommend T endocrine society clinical practice guidelines hypogonadism male for men with symptomatic T deficiency to induce and maintain secondary sex characteristics and correct symptoms of hypogonadism after discussing the potential benefits and risks of therapy and of monitoring therapy and involving the patient in decision making. The frequency of neuro-occlusive events in men with hypogonadism enrolled in RCTs of T who developed erythrocytosis has been very low. Cardiovascular risks of exogenous testosterone use among men: a systematic review and meta-analysis. Secondary Hypogonadism. In hypogonadal men whose baseline PSA is between 2. Epidemiological studies can only show association but cannot prove causality, and we cannot exclude reverse causality. Injectable T undecanoate: measure serum T levels at the end of the dosing interval just prior to the next injection and aim to achieve nadir levels in low-mid range.

Similar large interassay and interlaboratory variability occurs with FT measurements. Pharmacokinetic Profile. Clinicians should ideally measure TT using a CDC-certified assay or an assay verified by an accuracy-based external quality control program. Testosterone vs.

Preventive Services Task Force. Endocrine Society committees and members and the cosponsoring organization were invited to review and comment on preliminary drafts of the guideline. The task force used the best available research evidence to develop the recommendations. Longer term follow-up of endocrine society clinical practice guidelines hypogonadism male participants of the European Randomized Study of Screening for Prostate Cancer found that PSA-based screening for prostate cancer prevents one to two men from dying of prostate cancer for every men screened, and that screening men 55 to 69 years of age may prevent approximately three men from developing metastatic prostate cancer. Peter J Snyder. Effects of testosterone treatment on glucose metabolism and symptoms in men with type 2 diabetes and the metabolic syndrome: a systematic review and meta-analysis of randomized controlled clinical trials. AUS in particular emphasises the importance of being able to frame a diagnosis of MH in the context of a recognised cause, i.

The trials included in these meta-analyses suffered from various limitations, including heterogeneity of eligibility criteria, clinical practice, formulations, and intervention durations; variability in the quality of adverse event recording; lack of large trial cohorts; failure to prespecify and adjudicate cardiovascular outcomes; and lack of a sufficient number of MACE. Most clinical laboratories measure LH and FSH levels using immunometric assays that have sufficient sensitivity to distinguish between normal and low levels. Transient PSA elevations are common and may be due to test—retest variability or other disorders, such as prostatitis, benign prostatic hyperplasia, prostate trauma, urinary tract infections, or assay variability. We recommend measuring fasting morning total T concentrations using an accurate and reliable assay as the initial diagnostic test.

Peter J Snyder. In men with secondary hypogonadism, clinicians should perform serum prolactin and iron saturation hyoogonadism, and in certain cases, pituitary function testing and magnetic resonance imaging of the sella turcica to determine the cause of gonadotropin deficiency. Cancer Epidemiol Biomarkers Prev. Insulin resistance and inflammation in hypogonadotropic hypogonadism and their reduction after testosterone replacement in men with type 2 diabetes. T2DM is associated with a high prevalence of low T concentrations.

Gonadal steroid-dependent effects on bone turnover and skciety mineral density in men. Men who have prepubertal onset of hypogonadism that is not adequately treated will exhibit eunuchoidal proportions, lack of development of secondary sex characteristics, and high-pitched voice eunuchodism 56. Director, Boston Claude D. Sign In or Create an Account. This guideline describes the diagnosis, treatment, and monitoring of T deficiency and does not address isolated defects of spermatogenesis.

Response to comment on: Jones et al. Clinicians should not administer testosterone therapy to men with endocrjne hematocrit above the upper limit of normal for the laboratory without discussing the potential for an increased risk of erythrocytosis and the need to monitor hematocrit assiduously. Mol Cell Endocrinol. Conditions associated with increased SHBG concentrations. Public Health Rev. Performance of total testosterone measurement to predict free testosterone for the biochemical evaluation of male hypogonadism.

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Predictive accuracy and sources of variability in calculated free testosterone estimates. Performance of total testosterone measurement to predict free testosterone for the biochemical evaluation of male hypogonadism. Oral T undecanoate a : monitor serum T concentrations 3—5 h after ingestion with a fat-containing meal. High serum testosterone is associated with reduced risk of cardiovascular events in elderly men. An important objective of the baseline evaluation in men being considered for T-replacement therapy is to identify and exclude those who have a history of prostate cancer or are at high risk for developing prostate cancer. Studies were placebo-controlled trials that used randomization or allocation-by-minimization with low-to-moderate risk of bias. Randomized and open-label trials in young men with hypogonadism report a low frequency of serious adverse events with replacement doses of T 86—

Explain the potential benefits and risks of monitoring for prostate cancer and engage the patient in shared decision making regarding the prostate monitoring plan. Endocrine society clinical practice guidelines hypogonadism male flexibility of dosing, ease of hypogojadism, good skin tolerability; less erythrocytosis than injectable T. Additionally, there is no conclusive evidence that T supplementation is associated with increased cardiovascular risk in hypogonadal men. This recommendation also places a high value on avoiding interventions with unclear outcomes. Some men may develop a new prostate cancer unrelated to T treatment. T therapy does not improve ejaculatory function in men with low T concentrations and ejaculatory dysfunction Am J Psychiatry.

In placebo-controlled guidelines hypogonadism male in healthy and mobility-limited socidty men, T therapy resulted in greater gains in lean body mass LBMmaximal voluntary strength, muscle power, and some performance-based measures of physical function vs placebo 79— End-stage renal disease a. Spermatogenesis can be stimulated and fertility can be restored with appropriate gonadotropin therapy in patients with secondary hypogonadism but not in patients with primary hypogonadism. Low free testosterone is associated with hypogonadal signs and symptoms in men with normal total testosterone.

The commissioned systematic review and meta-analysis showed that T treatment in hypogonadal men endocrine society clinical practice guidelines hypogonadism male low libido is associated with significantly greater improvement in libido, erectile function, and practicee activity vs placebo 53— In these trials, T treatment consistently increased LBM and vertebral BMD and decreased fat mass, but the effects on muscle strength, physical function, femoral bone density, sexual function, energy, and mood were variable. Compared with placebo, T treatment was associated with a significantly greater increase in coronary artery noncalcified plaque volume, as measured by coronary computed tomographic angiography Also, a small fraction of healthy young men have a T concentration below the normal range during a hour period

See Tables 5 and 6 for additional safety and pharmacokinetics information. Selection of optimal prostate specific antigen cutoffs for early detection of prostate cancer: receiver operating characteristic curves. In men deemed to have secondary hypogonadism, additional diagnostic evaluations may be needed to exclude hyperprolactinemia, head trauma, iron overload syndromes, hypothalamic or pituitary tumors, and other infiltrative or destructive hypothalamic—pituitary diseases, as well as genetic disorders associated with gonadotropin deficiency. T directly stimulates bone formation and inhibits bone resorption through multiple mechanisms that involve estrogen receptor— and androgen receptor—mediated processes 14 Performance of total testosterone measurement to predict free testosterone for the biochemical evaluation of male hypogonadism. Prostate biopsy may be associated with adverse effects such as pain, fever, bleeding, infection, transient urinary difficulties, the psychological harm of false-positive test results, and overdiagnosis Conclusions: We recommend making a diagnosis of hypogonadism only in men with symptoms and signs consistent with testosterone T deficiency and unequivocally and consistently low serum T concentrations.

There is a high prevalence of low T concentrations in HIV-infected men 40, In men prsctice to have androgen deficiency, we recommend additional diagnostic evaluation to ascertain the cause of androgen deficiency. The symptoms and signs of T deficiency endocrine society clinical practice guidelines hypogonadism male nonspecific and modified by age, comorbid illness, severity and duration of T deficiency, variations in androgen sensitivity, and previous T therapy. Clinicians should monitor men receiving T therapy using a standardized plan that includes: evaluating symptoms, adverse effects, and compliance; measuring serum T and hematocrit concentrations; and evaluating prostate cancer risk during the first year after initiating T therapy. Search ADS. The response of metastatic adenocarcinoma of the prostate to exogenous testosterone. TT and FT concentrations fall with increasing age in men 1291 ,

Skip Nav Destination Article Navigation. Thrombophilia in 67 patients with thrombotic events after starting testosterone therapy. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies. Conditions that are associated with decreased SHBG concentrations. The Endocrine Society maintains a rigorous conflict-of-interest review process for developing clinical practice guidelines.

Peter J Snyder. Eur Urol. An important goal of the monitoring plan is to detect those who develop a prostate cancer during T treatment regardless of its relationship to T treatment to evaluate those at increased risk of having a prostate cancer and to minimize the risk of unnecessary prostate biopsy in those who are not at increased risk of prostate cancer. Effects of long-term testosterone administration on cognition in older men with low or low-to-normal testosterone concentrations: a prespecified secondary analysis of data from the randomised, double-blind, placebo-controlled TEAAM trial. Conflicts of interest are defined as remuneration in any amount from commercial interests; grants; research support; consulting fees; salary; ownership interests [ e. New York, NY : Elsevier ; : —

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Wilson JMG. The ES considers advanced age to be a cause of organic PH, but not lose weight drinking diet green tea cause of organic HH, whereas AUS does not consider age to cause any form of MH and does not necessarily consider a raised LH level in an older man as indicating pathological MH meritorious of testosterone treatment. The variability in T measurements is partly due to calibrator differences and to biotin interference in some immunoassays. Serum T concentrations vary significantly as a result of diurnal, circadian, and circannual rhythms, episodic secretion, and assay variations 18 An initial morning measurement of total T concentration is universally recommended for case-detection, but guidelines differ significantly in respect of whether:. No RCT has been long enough or large enough to have adequate statistical power to determine whether T administration increases the risk of prostate cancer.

Table 4. Effect of testosterone treatment on volumetric bone density and hypogonadjsm in older men with low testosterone: a controlled clinical trial. J Androl. The guidelines are not intended to dictate the treatment of a particular patient. Indeed, among men with congenital MH, the occurrence of PCa during T treatment is so vanishingly rare that we have been able to identify less than 10 published reports [ 49 ].

Despite guielines attenuation of the diurnal rhythm in older men, a substantial fraction of to year-old men who have low serum Endocrine society clinical practice guidelines hypogonadism male concentrations in the afternoon will have normal T concentrations in the morning 9. No clinical trials have assessed the effectiveness of screening strategies. Symptoms should be present, including impaired libido, erections, and fertility; reduced lean body mass and bone density; loss of facial, axillary, and pubic hair; anemia; and changes in mood and vitality.

In men whose total T is near the lower limit of normal or who have a condition that alters sex hormone—binding globulin, we recommend obtaining a free T concentration using either equilibrium dialysis or estimating it using an accurate formula. Abrupt decrease in serum testosterone levels after an oral glucose load in men: implications for screening for hypogonadism. Abbreviations: DHT, dihydrotestosterone; E2, estradiol. Opioids increase hip fracture risk: a meta-analysis.

  • Chapter, Classification of hypothalamic-pituitary-gonadal HPG axis endocrine disorders.

  • Type 2 diabetes mellitus and testosterone: a meta-analysis study.

  • Impact of testosterone replacement therapy on myocardial infarction, stroke, and death in men with low testosterone concentrations in an integrated health care system. Patients should be monitored regularly during the first year and annually thereafter.

  • Prostate cancer treatment can result in erectile dysfunction, urinary incontinence, bowel dysfunction, and a small risk of premature death. The effect of diurnal variation on clinical measurement of serum testosterone and other sex hormone levels in men.

  • Access this abstract now.

  • The task force also used consistent language and graphical descriptions of both the strength of a recommendation and the quality of evidence. Formulation-specific adverse effects.

Testosterone increased hemoglobin in both men with anemia of a known cause and in those having unexplained anemia. After 1 year of testosterone-replacement therapy, we suggest clinicians follow the guidelines for prostate cancer screening based on the age and race of the patient. Clinicians should consider T-replacement therapy in men with opioid-induced hypogonadism who are experiencing sexual symptoms and in whom discontinuation of opioid medication seems unlikely. Frequent occurrence of hypogonadotropic hypogonadism in type 2 diabetes. This recommendation also places a high value on avoiding interventions with unclear outcomes.

Potential risk for T transfer to partner or another practice guidelines hypogonadism who is in close contact need to remind patient to cover application sites with clothing and to wash skin and hands with soap before gidelines skin-to-skin contact with another person. Local laboratories usually do not have accurate and reliable assays for FT measurement. Given the uncertainties in the methods of calculations and variations in reference intervals, laboratories are encouraged to establish their own specific reference ranges for FT measured by equilibrium dialysis and calculated FT preferably calibrated against the equilibrium dialysis method. Clinicians should evaluate symptoms and signs of testosterone deficiency and formulation-specific adverse events at each visit see Table 9. Table 4.

The adverse event rates did not differ significantly between placebo and T groups. J Sex Med. Summary of Recommendations.

  • Clomiphene citrate has been used empirically in men with hypogonadotropic hypogonadism; however, neither its efficacy nor its safety has been demonstrated in randomized trials.

  • In one RCT in men with opioid-induced T deficiency, T administration improved pain sensitivity, sexual desire, body composition, and some aspects of quality of life The increases were greater in trabecular bone than peripheral bone and greater in the spine than the hip.

  • For many other chronic diseases, patients are increasingly contributing to guidance, but with notable exceptions [ 61 ] the patient experience of treatment in MH—frequently preceded by a prolonged diagnostic odyssey—is not well-represented in guidance. Decrementing values for LLN should apply to correspondingly older men?

  • Table 7. Accessed 4 December

  • Clinicians should monitor men receiving T therapy using a standardized plan that includes: evaluating symptoms, adverse effects, and compliance; measuring serum T and hematocrit concentrations; and evaluating prostate cancer risk during the first year after initiating T therapy. Ronald S Swerdloff.

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Testosterone deficiency is associated with increased sociiety of mortality and testosterone replacement improves survival in men with type 2 diabetes. This is indeed an area that is ripe for a truly multidisciplinary review of the evidence. Retrospective analyses of data using electronic medical records have also been inconclusive and are similarly constrained by the lack of randomized allocation and prospective adjudication of cardiovascular events, confounding by indication, and heterogeneity of patient populations, T doses, and intervention durations 96— Two RCTs in community-dwelling older men did not find significant improvements in memory or multiple other domains of cognitive function with T treatment 84 For men receiving injectable testosterone, having a significant peak-trough difference in levels, the ES recommends monitoring blood tests be performed done at the mid-point between injections. Hypogonadism as a risk factor for cardiovascular mortality in men: a meta-analytic study.

There are no trials of case-detection strategies in the patient populations described above. Organizational Financial. Hypopituitarism in primary haemochromatosis; recovery after iron depletion. Khoo TK. Accessed 4 September Androgens and coronary artery disease.

Prevalence of symptomatic androgen deficiency in men. Testosterone concentrations guiedlines significant diurnal and day-to-day variations and may be suppressed by endocrine society clinical practice guidelines hypogonadism male intake or glucose. Estrogen predominantly mediates the effects of T on body fat 13 Cardiovascular risks and elevation of serum DHT vary by route of testosterone administration: a systematic review and meta-analysis. Liquid chromatography—tandem mass spectrometry assays for TT generally offer higher concentrations of specificity, sensitivity, and precision especially in the low range than do most immunoassays.

Low free testosterone is associated with hypogonadal signs and symptoms in clinicap tea normal total testosterone. After prolonged use of highly supraphysiologic doses of AAS, the recovery of the hypothalamic—pituitary—testicular axis may take months and even years and may be incomplete. Our diagnostic strategy reflects our preference to avoid labeling men as having hypogonadism and requiring T therapy based on low T concentrations due to transient medical disorders, biological variations in T concentrations, technical variations and inaccuracy in T measurements, or SHBG abnormalities. Effects of hypogonadism and testosterone administration on depression indices in HIV-infected men.

  • Prostate cancer: screening.

  • Clinicians should also measure FT in men whose serum TT concentration is modestly above or below the lower limit of normal e.

  • Managing the underlying conditions, such as obesity, may have additional health benefits. Organ failure liver, heart, and lung a.

  • Serum T peaks at 1 month and then is sustained in normal range for 3—6 mo, depending on formulation.

  • Construction and field validation of a self-administered screener for testosterone deficiency hypogonadism in ageing men.

Old age: with increasing numbers of men surviving into their 9th and 10th decades, is there any chronological age above which concerns arise endocrinee respect of testosterone prescribing, even with a verified diagnosis of organic, syndromic, or pathological MH? However, surprisingly underplayed in all guidelines, is the concept that a raised Hct makes MH rather improbable in the first place. Advance article alerts. In contrast, for younger men with anemia, or low bone density, achieving a higher level is probably justified [ 21 ].

In this guideline, hypogonadism male task force made several statements to emphasize the importance of: informing the patient regarding potential benefits and risks of testosterone treatment and of monitoring treatment; shared decision making; general preventive care measures; and basic principles of androgen deficiency screening, diagnosis, and treatment. Tables 5 and 6 summarize the clinical pharmacology of T formulations. An important goal of the monitoring plan is to detect those who develop a prostate cancer during T treatment regardless of its relationship to T treatment to evaluate those at increased risk of having a prostate cancer and to minimize the risk of unnecessary prostate biopsy in those who are not at increased risk of prostate cancer. Public Health Rev.

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