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Endocrine society male hypogonadism guidelines – Evaluation and Treatment of Male Hypogonadism

Not all hypogonadal men are necessarily infertile; a semen analysis may be performed prior to initiating treatment to determine whether contraception is needed.

William Murphy
Tuesday, June 4, 2019
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  • Table 2. Clinicians should use an accurate and reliable method, optimally, an assay that has been certified by an accuracy-based standardization or quality control program [e.

  • Trials of the effects of T on glycemic control have also yielded variable results; some show no improvement in hemoglobin A1c HbA1cwhereas others show a decrease.

  • Br J Gen Pract. All major guidelines recommend measuring serum T in patients who exhibit core clinical features of MH.

  • Ideally, case detection should identify those patients who seek medical attention for one or more medical problems who are at increased risk of having hypogonadism and likely to benefit from T therapy. Cancer Epidemiol Biomarkers Prev.

  • It may be that a higher Hct directly promotes thrombogenicity; alternatively, secondary, or relative polycythaemia where red cell mass is normal, but plasma volume is reduced may simply be a manifestation of the increased vascular tone associated with cardiometabolic disease [ 52 ].

Summary of Recommendations

S-testosterone decrease after a mixed meal endodrine healthy men independent of SHBG and gonadotrophin levels. Although these new scales are psychometrically more robust than previous instruments, clinical experience with them is limited. There are no data on the effects of T on physical function, risk of disability, or long-term safety. Editor's Choice. Ungraded Good Practice Statement.

Low T concentrations occur frequently without soociety or signs of testosterone deficiency, and these low levels alone do not establish a diagnosis of hypogonadism. Given the uncertainties in the methods of calculations and variations in reference intervals, laboratories are encouraged to establish their own specific guide,ines ranges for Obesity epidemic measured by equilibrium dialysis and calculated FT preferably calibrated against the equilibrium dialysis method. Some men may develop a new prostate cancer unrelated to T treatment. There are no studies on the effects of T on men with dementia or on the progression from mild cognitive impairment to dementia. The clinical features associated with true male hypogonadism are nonspecific and include impaired libido, erections, and fertility; reductions in lean muscle mass and bone density; loss of facial, axillary, and pubic hair; anemia; and changes in mood and vitality. Cancer Epidemiol Biomarkers Prev. The effect of changes in adiposity on testosterone levels in older men: longitudinal results from the Massachusetts Male Aging Study.

Table 1. Testosterone was marginally more effective than PDE5-inhibitors in respect endocrine society male hypogonadism guidelines sexual functioning; albeit any superiority may vuidelines last beyond a year from initiation. Testosterone replacement therapy improves insulin resistance, glycaemic control, visceral adiposity and hypercholesterolaemia in hypogonadal men with type 2 diabetes. Clin Infect Dis. Reid IR. The role of long-acting parenteral testosterone undecanoate compound in the induction of secondary sexual characteristics in males with hypogonadotropic hypogonadism. Twitter Facebook Email.

INTRODUCTION

An approach to low testosterone levels in primary care. The impact of untreated T deficiency on mortality is unclear, although several, but not all, epidemiological studies have reported an association of low T concentrations with higher all-cause mortality particularly mortality due to cardiovascular disease Clinicians should not use direct analog-based free testosterone immunoassays, as they are inaccurate.

  • Diabetes in myotonic dystrophy.

  • Effects of testosterone replacement in hypogonadal men. Bulliard J-LChiolero A.

  • If fertility is a concern to a patient and his partner, clinicians should perform at least two semen analyses separated by an interval of several weeks on semen samples collected within 1 hour of ejaculation after at least 48 hours of abstinence. Diabetes Care.

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. Incomplete or delayed sexual development, loss of secondary sex characteristics such as body hairand very small testes are specific manifestations of hypogonadism Table 3. The Endocrine Society shall not be liable for direct, indirect, special, incidental, or consequential damages related to the use of the information contained herein. In men determined to have androgen deficiency, we recommend additional diagnostic evaluation to ascertain the cause of androgen deficiency. Low free testosterone is associated with hypogonadal signs and symptoms in men with normal total testosterone. The frequency of neuro-occlusive events in men with hypogonadism enrolled in RCTs of T who developed erythrocytosis has been very low.

Furthermore, many hypogonafism been prescribed testosterone without any prior testing obesity epidemic serum T level, or even more worryingly with normal initial T level [ 1617 ]. Decrementing values for LLN should apply to correspondingly older men? The reported reference ranges for TT and FT concentrations in healthy young men vary considerably among laboratories and assays It is possible that T is a marker of health, and those who are at higher risk of dying have lower T concentrations.

Publications

Williams Textbook of Endocrinology. Prevalence of hypogonadism among men with weight loss related to human immunodeficiency virus infection who were receiving highly active antiretroviral therapy. Many men with secondary hypogonadism have potentially reversible or treatable causes of gonadotropin suppression and low T concentrations or functional secondary hypogonadism [ e. 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. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy Continue.

We suggest that clinicians offer evaluation of prostate cancer risk beginning at age 40 in hypogonadal men who are being considered for testosterone therapy and are at high risk of prostate cancer e. SMD of 0. Using the lower limit of the range established in local laboratories may not accurately identify men with hypogonadism. BSSM and CMAJ concur, but also specifically link MH to advancing age and accumulating comorbidities, albeit without considering the likelihood of low serum T in these contexts being instead a non-gonadal epiphenomenon expressed as part of the acute phase response. The responsible use of antibiotics for an elevated PSA level. Contributors to the substantial variation in on-treatment testosterone levels in men receiving transdermal testosterone gels in randomized trials.

This recommendation also places a high value on avoiding interventions with unclear outcomes. Vending machines in schools causing obesity epidemic articles via Web of Science Views 21, The reported reference ranges for TT and FT concentrations in healthy young men vary considerably among laboratories and assays 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. Osteoporosis in men: an Endocrine Society clinical practice guideline. Eur Heart J.

Search ADS. Uncommon adverse events for which there is weak evidence of association with T administration. Wu FCvon Eckardstein A. The task force used the best available research evidence to develop the recommendations. Multiple daily intranasal dosing required; local nasal side effects, not appropriate for men with nasal disorders.

Contributors to the substantial male hypogonadism guidelines in on-treatment testosterone levels in men receiving transdermal testosterone gels in randomized trials. 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. Grading quality of evidence and strength of recommendations. Additionally, T may increase skeletal muscle mass and strength, which may indirectly increase BMD and potentially reduce fall propensity and fracture risk; however, there are no randomized trials that assess the effect of T on fall and fracture prevention.

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Create a free personal account to access your subscriptions, sign up for alerts, and more. Osteoporosis in vending machines in schools causing obesity epidemic an Endocrine Society clinical practice guideline. Managing the risks of prostate disease during testosterone replacement therapy in older men: recommendations for a standardized monitoring plan. Clin Endocrinol Oxf ; 79 — Testosterone replacement in androgen-deficient men with ejaculatory dysfunction: a randomized controlled trial. Trends in androgen prescribing in the United States, to

The classification of hypogonadism as primary or secondary has therapeutic implications. Get free access to newly published articles. 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. Cancer Epidemiol Biomarkers Prev.

Restores serum T, DHT, and Guiedlines concentrations to the physiological male range; absorbed from the buccal mucosa. No clinical trials have assessed the effectiveness of screening strategies. Hypothalamic—pituitary—testicular axis disruptions in older men are schools causing linked to age and modifiable risk factors: the European Male Aging Study. The role of long-acting parenteral testosterone undecanoate compound in the induction of secondary sexual characteristics in males with hypogonadotropic hypogonadism. Google Scholar. Testosterone treatment and risk of venous thromboembolism: population based case-control study. The Endocrine Society makes no warranty, express or implied, regarding the guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose.

Summary of Recommendations

There is limited evidence that T improves depressive symptoms in middle-aged and elderly men with late-onset, low-grade, persistent depressive disorder and low T concentrations 66 T administration has also been associated with improvements in maximal voluntary strength Based on these considerations, we recommend that clinicians obtain a urological consultation if a prostatic abnormality is detected on DRE.

However, randomized controlled trials RCTs have failed to demonstrate further improvements in erectile function with the addition of T to an optimized regimen of phosphodiesterase 5 inhibitors 58 Anabolic steroid induced hypogonadism in young men. Clin Appl Thromb Hemost. Explain the potential benefits and risks of monitoring for prostate cancer and engage the patient in shared decision making regarding the prostate monitoring plan. Klinefelter syndrome: expanding the phenotype and identifying new research directions. Ann Clin Biochem. Williams Textbook of Endocrinology.

Heritability can explain a substantial fraction of population-level variations in T endocrine society male hypogonadism guidelines among men Based on these considerations, we recommend that clinicians obtain a urological consultation if a prostatic abnormality is detected on DRE. The Endocrine Society shall not be liable for direct, indirect, special, incidental, or consequential damages related to the use of the information contained herein. Factors affecting spermatogenesis upon gonadotropin-replacement therapy: a meta-analytic study. Postgrad Med J. Cochrane Database Syst Rev.

  • Importantly, men with low TT but normal FT concentrations were more obese and presumably had lower SHBG levels and did not have associated sexual or physical symptoms

  • Int J Cancer.

  • A Cochrane review also found greater weight and LBM gains in men assigned to androgens than in those assigned to placebo arms of RCTs

  • Serum dihydrotestosterone and testosterone concentrations in human immunodeficiency virus-infected men with and without weight loss.

  • Clinicians should monitor men guidelines T therapy using a standardized plan that includes: evaluating symptoms, adverse guideliness, and compliance; measuring serum T and hematocrit concentrations; and evaluating prostate cancer risk during the first year after initiating T therapy. 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 intention of these statements is to draw endocrine society male hypogonadism guidelines and remind providers of these principles 3. A double-blind, placebo-controlled trial of testosterone therapy for HIV-positive men with hypogonadal symptoms. In men who have conditions that alter sex hormone—binding globulin SHBG Table 2or whose initial total testosterone concentrations are at or near the lower limit of the normal range Fig. Importantly, men with low TT but normal FT concentrations were more obese and presumably had lower SHBG levels and did not have associated sexual or physical symptoms

Testosterone did not improve vitality score, physical function, or cognitive function. Some studies have demonstrated a favorable effect of T on insulin sensitivity in men with T2DM —whereas others showed no benefit 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. In addition to pituitary disease, investigating other potential causes of HH is recommended by some, but not all guidelines. Eugonadal men who develop androgen-sensitive prostate cancer, treated with curative intent, routinely receive androgen-deprivation therapy for a period of 6 to 24 months depending on tumor phenotype [ 48 ] and, therefore, from basic first principles, the same occurrence in a hypogonadal man ought not prompt interruption of testosterone treatment for longer than 2 years. The EAU recommends calculating free T in case of discrepancy between serum total T and symptoms, while the ES recommends the use of calculated free T in the presence of conditions that alter SHBG levels, or when serum T levels are in the borderline range.

LH and FSH hypogonadism guidelines are susceptible soiety biotin interference 47 that can cause falsely high or low values; accordingly, clinicians should stop biotin supplements for at least 72 hours before testing. Reference ranges for testosterone in men generated using liquid chromatography tandem mass spectrometry in a community-based sample of healthy nonobese young men in the Framingham Heart Study and applied to three geographically distinct cohorts. Many older men harbor small foci of subclinical cancer in their prostate ; we do not know whether T replacement might cause these subclinical cancers to grow and become clinically overt. A substantial amount of the variation in reference ranges is due to the lack of standardization of T assays, calibrator differences, and differences in the reference populations used to generate ranges.

  • Monitoring of Testosterone-Replacement Therapy. Practice Update ADA Testosterone plus lifestyle program reduced risk of type 2 diabetes in overweight and obese men [Internet] Amsterdam: Elsevier; c

  • Conflicts of interest are defined as remuneration in any amount from commercial interests; grants; research support; consulting fees; salary; ownership interests [ e.

  • A Cochrane review also found greater weight and LBM gains in men assigned to androgens than in those assigned to placebo arms of RCTs

  • No other entity provided financial or other support.

AAS withdrawal after an extended period of high-dose AAS use is associated with marked suppression of endogenous T concentrations and severe symptoms of AAS withdrawal vending machines in schools causing obesity epidemic, including sexual dysfunction, fatigue, depressed mood, and sometimes clinical depression and even suicidality Nat Rev Endocrinol. Restores serum T, DHT, and E2 concentrations to the physiological male range; absorbed from the buccal mucosa. Coughing episodes immediately after the intramuscular injection a. TT concentrations are measured using radioimmunoassay, immunometric assays, or liquid chromatography—tandem mass spectrometry. Analysis of variation in prostate-specific antigen values.

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No other entity provided financial or other support. Most organizations that provide guidelines for prostate cancer screening strongly encourage informing the patient of gguidelines potential benefits and risks and engaging him in shared decision making regarding screening with PSA levels and digital rectal examination DRE Effects on liver and cholesterol b. Furthermore, we still do not know the long-term efficacy of T in improving patient-important outcomes, such as disability, falls, fractures, low-grade progressive depressive disorder, and progression to diabetes or dementia. Check hematocrit at baseline, 3—6 mo after starting treatment, and then annually.

Furthermore, many have been prescribed testosterone without any prior testing of serum Endocrine society male level, or even more worryingly with normal initial T level [ 1617 ]. 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 N Engl J Med. Pharmacokinetic profile. An approach for the diagnostic evaluation of adult men suspected of having T deficiency. Endogenous sex hormones and prostate cancer: a collaborative analysis of 18 prospective studies. Furthermore, a small fraction of hypogonadal men develop supraphysiologic T concentrations with intramuscular T and may be susceptible to dose-related adverse effects.

T therapy may increase the risk of serious adverse effects in men with some enrocrine Table 7 ; we recommend against using T therapy in patients with these disorders. Prognostic significance of digital rectal examination and prostate specific antigen in the prostate, lung, colorectal and ovarian PLCO cancer screening arm. Testosterone therapy in HIV wasting syndrome: systematic review and meta-analysis. 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.

Eur Urol. J Gen Intern Med. The pharmacokinetics of the T formulation should guide the timing of therapeutic level monitoring, as shown in Table 9. The classification of hypogonadism as primary or secondary has therapeutic implications.

  • T-replacement therapy increases PSA concentrations in hypogonadal men.

  • Potential of transfer to a female partner or child by direct skin-to-skin contact; T concentrations may be variable from application to application; skin irritation in a small proportion of treated men; moderately high DHT concentrations of unknown significance.

  • Testosterone and obesity.

  • The Endocrine Society maintains a rigorous conflict-of-interest review process for developing clinical practice guidelines. The effect of finasteride in men with benign prostatic hyperplasia.

  • Combined primary and secondary hypogonadism, but classified to usual predominant hormonal pattern. A Cochrane review also found greater weight and LBM gains in men assigned to androgens than in those assigned to placebo arms of RCTs

  • The Endocrine Society makes no warranty, express or implied, regarding the guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose. Eur Urol.

Finally, it is estimated that patients with chronic diseases end up delivering the major proportion of their overall medical care, by keeping track of and attending appointments, attending for monitoring bloods, requesting and collecting drug prescriptions, reporting clinical responses and adverse effects, and adhering to lifestyle guidance. However, androgen receptor signaling plays a central role in the biology of prostate cancer, T administration promotes the growth of metastatic prostate cancer, and androgen ablation can provide benefits for aggressive prostate cancer Hypogonadism as a risk factor for cardiovascular mortality in men: a meta-analytic study. 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. Pituitary mass, radiation to the pituitary region, or other diseases of the sellar region Treatment with medications that affect T production or metabolism, such as opioids and glucocorticoids Withdrawal from long-term AAS use HIV-associated weight loss Infertility Osteoporosis or low trauma fracture Low libido or erectile dysfunction. SMD of 0.

View Metrics. The task force has confidence that persons who receive care according to the strong recommendations will derive, on average, more good than harm. Effects of testosterone on muscle strength, physical function, body composition, and quality of life in intermediate-frail and frail elderly men: a randomized, double-blind, placebo-controlled study. Citing articles via Web of Science

Publication types

Managing the underlying conditions, such as obesity, may have additional health benefits. 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 Accessed 4 September

Pituitary mass, radiation to the pituitary region, or other diseases of the sellar region Treatment with medications that affect T production or metabolism, such as opioids and glucocorticoids Withdrawal from epidemic AAS use HIV-associated weight loss Infertility Osteoporosis or low trauma fracture Low libido or erectile dysfunction. CT scan may be sufficient if macroadenoma is suspected or to assess parasellar bone involvement. However, most meta-analyses have not shown a statistically significant association between T treatment and cardiovascular events, MACE, or deaths. Testosterone concentrations exhibit significant diurnal and day-to-day variations and may be suppressed by food intake or glucose. The task force also used consistent language and graphical descriptions of both the strength of a recommendation and the quality of evidence.

Genetic determinants of serum testosterone concentrations in men. As testosterone therapy is not without risk several clinical practice guidelines have been published specialist societies to guide physicians endocrine society male hypogonadism guidelines best practice. J Am Coll Cardiol. Effect of transdermal testosterone and oral progesterone on drug-induced qt interval lengthening in older men: a randomized, double-blind, placebo-controlled crossover-design study. Create a free personal account to access your subscriptions, sign up for alerts, and more. Surveys of middle-aged and older men with secondary hypogonadism and sexual dysfunction have revealed a low prevalence of hypothalamic—pituitary abnormalities

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. Table 7. The guidelines are not intended to dictate the treatment of a particular patient. Local laboratories usually do not have accurate and reliable assays for FT measurement. Table 4 lists candidate groups that have a high prevalence of low T concentrations and for whom we suggest measuring T concentrations; these include men with low libido, erectile dysfunction, infertility, HIV-associated weight loss, osteoporosis or low-trauma fracture, a history of AAS use, and men receiving opioids or other drugs or substances that affect T production or metabolism 5635—

Moreover, men in the T group reported more adverse events e. This should start at age 40 in men hypogonadism guidelines are at increased risk for high-grade cancers, such as African Americans and men with a first-degree male relative with diagnosed prostate cancer. Prostate cancer treatment can result in erectile dysfunction, urinary incontinence, bowel dysfunction, and a small risk of premature death. Harmonized reference ranges for circulating testosterone levels in men of four cohort studies in the United States and Europe.

Guideilnes rely on local laboratory normal ranges, or instead conform to a universal cut-off serum T value to define the lower limit of normality LLN ; if so, what that value should be? Skip Nav Destination Article Navigation. N Engl J Med. 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. Harmonized reference ranges for circulating testosterone levels in men of four cohort studies in the United States and Europe. When administered at a dose of mg IM, serum T concentrations are maintained in the normal range in most treated men.

Raju K, Venkataramappa SM. Treatment with medications that affect Endocrine society male hypogonadism guidelines production or metabolism, such as opioids and glucocorticoids. 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. 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. Men who have a prostate nodule or induration require a urological evaluation.

No clinical trials wndocrine assessed the effectiveness of screening strategies. Serum T concentrations exhibit a diurnal variation with peak values in the morning; aging reduces the magnitude of this diurnal variation Oral phosphodiesterase-5 inhibitors and hormonal treatments for erectile dysfunction: a systematic review and meta-analysis. The guidelines should not be considered inclusive of all proper approaches or methods, or exclusive of others. Serum T concentrations vary significantly as a result of diurnal, circadian, and circannual rhythms, episodic secretion, and assay variations 18 PLoS Genet. No other entity provided financial or other support.

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The EAU recommends calculating free T in case of discrepancy between serum total T and symptoms, while the ES recommends the use of calculated free T in the endocrine society male hypogonadism guidelines of conditions that alter SHBG levels, or when serum T levels are in the borderline range. Response to comment on: Jones et al. Is MH or TDS a final diagnosis in its own right, or does it require a higher-order descriptor in order to be fully characterized and credible, such as HH due to opiate use, or PH due to Klinefelter syndrome? However, a distinct lack of consensus on how to approach MH is evident from the guidelines that we reviewed, hence potentially adding to confusion and uncertainty in certain areas, rather than reducing it. Suggestive symptoms and signs. Adverse health consequences of performance-enhancing drugs: an Endocrine Society scientific statement.

The hematocrit level at which the risk of neuro-occlusive or cardiovascular events increases is not known. Potential risk for T transfer to partner or another person who is in close contact need to remind patient to cover application sites with clothing and to wash skin and hands with soap before having skin-to-skin contact with another person. Nonspecific age-related symptoms and low T concentrations often coexist in older men without a clear causal link. Androgens and coronary artery disease. The effect of changes in adiposity on testosterone levels in older men: longitudinal results from the Massachusetts Male Aging Study. Several different algorithms are available for calculating FT concentrations based on the binding characteristics of T to SHBG and albumin 28— The Endocrine Society makes no warranty, express or implied, regarding the guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose.

Effects of long-term testosterone administration on cognition in older hypogonadlsm with low or low-to-normal testosterone concentrations: a prespecified secondary analysis of data from the randomised, double-blind, placebo-controlled TEAAM trial. High serum testosterone is associated with reduced risk of cardiovascular events in elderly men. Treatment with medications that affect T production or metabolism, such as opioids and glucocorticoids. Editor's Choice.

Skip Nav Destination Article Navigation. Abstract Objective. Hematopoiesis shows closer correlation with calculated free testosterone in men than total testosterone. The MrOS osteoporotic fractures in men study in Sweden. In men determined to have androgen deficiency, we recommend additional diagnostic evaluation to ascertain the cause of androgen deficiency. Serum T concentrations in some T-deficient men may be in the low-normal range; these men may need applications of two patches daily; skin irritation at the application site occurs frequently in many patients.

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Association of endocrine society male hypogonadism guidelines levels with anemia in older men: a controlled clinical trial. When administered in castor oil, T undecanoate is absorbed hrough the lymphatics, bypassing the portal system; considerable variability in the same individual on different days and among individuals. Google Scholar PubMed. 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. Clinicians should evaluate symptoms and signs of testosterone deficiency and formulation-specific adverse events at each visit see Table 9.

  • TT concentrations are measured using radioimmunoassay, immunometric assays, or liquid chromatography—tandem mass spectrometry. N Engl J Med.

  • Screening and overdiagnosis: public health implications. Task Force Member.

  • The second review determined whether T-replacement therapy is associated endlcrine an increased risk of lower urinary tract symptoms and erythrocytosis in men with hypogonadism. Most organizations that provide guidelines for prostate cancer screening strongly encourage informing the patient of the potential benefits and risks and engaging him in shared decision making regarding screening with PSA levels and digital rectal examination DRE

  • In men determined to have androgen deficiency, we recommend additional diagnostic evaluation to ascertain the cause of androgen deficiency. Initial RCTs of T in older men were characterized by relatively small sample sizes, inclusion of healthy men without symptoms of T deficiency, low-normal rather than frankly low T concentrations, and variable elevations of T in treated men 79—828495 ,

  • Exogenous testosterone T alone or with finasteride increases physical performance, grip strength, and lean body mass in older men with low serum T.

Association of endogenous testosterone with subclinical atherosclerosis in men: the multi-ethnic study of atherosclerosis. The effects of opioids on the endocrine system: an overview. Testosterone therapy in men with hypogonadism: an Endocrine Society clinical practice guideline. The intention of these statements is to draw attention and remind providers of these principles 3.

We recommend measuring fasting morning total T concentrations gjidelines an accurate and reliable assay as the initial diagnostic test. Juan P Brito. Whilst acknowledging that aging men are prone hypogonadism guidelines accumulating comorbid illnesses resulting in low serum T levels, the ISSM, and BSSM nevertheless define this as a form of age-related MH, whose treatment implications are not substantially different from those of classical or organic MH. Oxford University Press is a department of the University of Oxford. Frances J Hayes. 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. Current guidelines state that there is no credible evidence that testosterone increases the risk of CV events, provided that it is prescribed appropriately to men with a well-founded diagnosis of MH.

The meta-analysis suggested that testosterone treatment was associated with a small but statistically significant improvement in libido [standardized mean difference SMD0. N Engl J Med. Adapted with permission from Bhasin et al.

Considerable heterogeneity across trials, varying degrees of weight loss and disease severity, variable T regimens and treatment durations, and imprecision all limited the strength of inferences. T guidelinees may be affected by acute illness, nutritional deficiency, and by certain medications e. A small minority of these men may never recover normal endogenous T production and require T-replacement therapy There was no significant difference in the change in lower urinary tract symptoms mean difference, 0. Financial Support: This guideline was supported by the Endocrine Society. Clin Appl Thromb Hemost. University of Manchester, Manchester, United Kingdom.

Uncompensated Leadership. Although the differences between the two treatment arms with regard to prostate and cardiovascular adverse outcomes were not statistically significant, the number of participants and the treatment duration in the TTrials were not sufficient male hypogonadism draw conclusions about the effect of T on these adverse outcomes. Prostate cancer: screening. Similarly, the detection of a prostate nodule or an induration may indicate an unrecognized cancer. Clinicians can make a diagnosis of congenital also referred to as idiopathic hypogonadotropic hypogonadism after excluding other causes of secondary hypogonadism in men with prepubertal or less commonly adult onset T deficiency. T therapy improves the positive and reduces the negative aspects of mood, but the magnitude of the effect of T on mood in older men is small 61 Managing the risks of prostate disease during testosterone replacement therapy in older men: recommendations for a standardized monitoring plan.

Table 3 lists signs and symptoms based on the clinical experience of severely T-deficient men and their response to T-replacement therapy 56 ; there are no population-based surveys of symptoms and signs in men with the full spectrum of severity of hypogonadism. Drug Alcohol Depend. Treatment of Hypogonadism With Testosterone.

Multiple dose titrations are usually necessary to maintain T concentrations endocrine society male hypogonadism guidelines the therapeutic range in hypogonadal men who are receiving T therapy. These technical comments reflect the best available evidence applied to a typical person being treated. As discussed earlier, T therapy increases the risk of detection of subclinical prostate disease due to increased surveillance and T-induced increases in PSA concentrations, which may lead to increased risk of prostate biopsy. The role of long-acting parenteral testosterone undecanoate compound in the induction of secondary sexual characteristics in males with hypogonadotropic hypogonadism. However, androgen receptor signaling plays a central role in the biology of prostate cancer, T administration promotes the growth of metastatic prostate cancer, and androgen ablation can provide benefits for aggressive prostate cancer ,

Stimulation of spermatogenesis by gonadotropins in men with hypogonadotropic hypogonadism. European Medicines Agency. In men with secondary hypogonadism, clinicians should perform serum prolactin and iron saturation hypogonacism, and in certain cases, pituitary function testing and magnetic resonance imaging of the sella turcica to determine the cause of gonadotropin deficiency. Testosterone treatment and sexual function in older men with low testosterone Levels. No consistent evidence of an increased risk of heart problems with testosterone medicines. However, most meta-analyses have not shown a statistically significant association between T treatment and cardiovascular events, MACE, or deaths. 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.

Clinicians must individualize the decision to treat or not to treat these men with T soiety on careful consideration of the severity male hypogonadism guidelines symptoms, the degree of T deficiency, confounding influence of the comorbid illness, patient preferences, and the uncertainty of the risks and benefits of T therapy. 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. Herein, we navigate the major clinical practice guidelines on male hypogonadism and test their respective recommendations against current best evidence. Pharmacokinetic Profile.

Current case-finding instruments for detecting testosterone deficiency lack sufficient sensitivity and specificity to be useful for hypogomadism men who are receiving health care for unrelated reasons. More than one sample is required for diagnostic purposes and, if so, what the minimum spacing between samples should be? Table 8 lists the adverse effects associated with the use of specific T formulations. Table 8.

We recommend measuring fasting morning total T concentrations using an accurate and reliable assay hypogojadism the initial diagnostic test. Our recommended diagnostic endocrine society male hypogonadism guidelines places a relatively higher value on detecting potentially reversible functional or organic conditions e. Clin Endocrinol Oxf. Int J Androl. Uncommon adverse events for which there is weak evidence of association with T administration. The trials included in these meta-analyses suffered from various limitations, including heterogeneity of eligibility criteria, dosing, 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.

E-mail: publications endocrine. The metabolic syndrome in central hypogonadotrophic hypogonadism. Clinicians should confirm PSA elevations by repeating the test to exclude the possibility of transient rises e. Prevalence of symptomatic androgen deficiency in men. A Cochrane review also found greater weight and LBM gains in men assigned to androgens than in those assigned to placebo arms of RCTs

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 Ann Intern Med. Prolonged hypogonadism in males following withdrawal from anabolic-androgenic steroids: an under-recognized problem. A major difficulty in interpreting FT concentrations is the lack of standardization regarding FT assays, resulting in variability in the lower limit of the reference ranges quoted by different laboratories. Massachusetts General Hospital, Boston, Massachusetts. Former abusers of anabolic androgenic steroids exhibit decreased testosterone levels and hypogonadal symptoms years after cessation: a case-control study.

An approach for the diagnostic evaluation of adult men suspected of having T deficiency. Tables 5 and 6 summarize the clinical pharmacology of T formulations. Who gets testosterone? Analysis of variation in prostate-specific antigen values.

Systemic illness a. Article Navigation. In a systematic review, the average PSA increase after initiating T therapy was 0. N Engl J Med. Based on these considerations, we recommend that clinicians obtain a urological consultation if a prostatic abnormality is detected on DRE. Thrombophilia in 67 patients with thrombotic events after starting testosterone therapy.

Clinicians should evaluate men who develop erythrocytosis during T-replacement therapy and withhold T therapy until hematocrit has returned to the normal range and ssociety resume T therapy at a lower dose. These technical comments reflect the best available evidence applied to a typical person being treated. Nonspecific age-related symptoms and low T concentrations often coexist in older men without a clear causal link. 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. T therapy improves the positive and reduces the negative aspects of mood, but the magnitude of the effect of T on mood in older men is small 61 ,

Endocrine Society of Australia position statement on male hypogonadism part male hypogonadism guidelines : assessment and indications for testosterone therapy. In surveys of community-dwelling middle-aged and older men, low libido, erectile dysfunction, and less specific symptoms such as fatigue, irritability, depressed mood, poor concentration, reduced physical performance, and sleep disturbance are associated with low T concentrations 10 Finally, it is estimated that patients with chronic diseases end up delivering the major proportion of their overall medical care, by keeping track of and attending appointments, attending for monitoring bloods, requesting and collecting drug prescriptions, reporting clinical responses and adverse effects, and adhering to lifestyle guidance. T2DM is associated with a high prevalence of low T concentrations. High serum testosterone is associated with reduced risk of cardiovascular events in elderly men. PLoS One.

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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. Am J Physiol Endocrinol Metab. 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. With appropriate dose, restores serum T and E2 concentrations to the physiological male range; less fluctuation of T concentrations than T enanthate or cypionate. Adverse events associated with testosterone administration.

  • The intention of these statements is to draw attention and remind providers of these principles 3.

  • 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. The guideline task force commissioned two systematic reviews to assist with summarizing the evidence base for this guideline.

  • In men with secondary hypogonadism, endocrine society male hypogonadism guidelines should perform serum prolactin and iron saturation measurements, and in certain cases, pituitary function testing and magnetic resonance imaging of the sella turcica to determine the cause of gonadotropin deficiency. Because of the current inability to reliably distinguish tumors that will remain indolent from those destined to be lethal, many men are being subjected to the harms of treatment of prostate cancer that might never become symptomatic.

  • However, these are heterogeneous in key areas, reflecting divergent approaches to the same evidence basis.

  • Available at: www. Testosterone therapy in hypogonadal men who have T2DM should follow the same treatment and monitoring plan as hypogonadal men without T2DM.

  • The ISSM and AUA recommend a mutual decision to be made between the patient and the physician taking into account benefits versus the potential risks.

Clinicians should monitor men receiving T therapy using a standardized plan that includes: evaluating symptoms, adverse effects, and compliance; schools causing obesity serum T and hematocrit concentrations; and evaluating prostate cancer risk during the first year after initiating T therapy. Overall, short-term 3 to 6 months T use in HIV-infected men 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. Testosterone concentrations exhibit significant diurnal and day-to-day variations and may be suppressed by food intake or glucose. The efficacy and adverse events of testosterone replacement therapy in hypogonadal men: a systematic review and meta-analysis of randomized, placebo-controlled trials. For men having no structural disease of the hypothalamic-pituitary-gonadal HPG axis, the AUS has adopted an age-adjusted serum T reference range, e.

Nevertheless, a pragmatic approach to evaluating calculated free T would acknowledge that, whilst endocriine is unlikely to provide an accurate measurement of actual circulating unbound T, studies have found it to correlate better than total T with several biological read-outs of androgen action, including bone density [ 35 ], sexual function [ 36 ], and haematopoeisis [ 37 ]. The cost-effectiveness of measuring BMD and the frequency at which it should be performed are not known. Potential risk for T transfer to partner or another person who is in close contact need to remind patient to cover application sites with clothing and to wash skin and hands with soap before having skin-to-skin contact with another person. Expert consensus document: European Consensus Statement on congenital hypogonadotropic hypogonadism—pathogenesis, diagnosis and treatment. Low free testosterone is associated with hypogonadal signs and symptoms in men with normal total testosterone. Front Horm Res.

Contributors endodrine the substantial variation in on-treatment testosterone levels in men receiving transdermal endocrine society male hypogonadism guidelines gels in randomized trials. Performance of total testosterone measurement to predict free testosterone for the biochemical evaluation of male hypogonadism. If fertility is a concern to a patient and his partner, clinicians should perform at least two semen analyses separated by an interval of several weeks on semen samples collected within 1 hour of ejaculation after at least 48 hours of abstinence. T administration increases hemoglobin and hematocrit 8889 ; these effects are related to T doses and circulating concentrations

Informed by TTT data, current ES guidance is significantly male hypogonadism stringent in respect of the diagnosis of MH and eligibility for testosterone treatment compared with its socuety iteration [ 41 ] and is thus much closer to AUS. Interventional studies designed to address whether low T concentrations contribute to the development of diabetes by modulating insulin resistance have yielded conflicting results. The frequency of neuro-occlusive events in men with hypogonadism enrolled in RCTs of T who developed erythrocytosis has been very low. Preventive Services Task Force. Postgrad Med J.

Evaluate formulation-specific adverse effects at each visit as per Table 5. Utility of digital rectal examination as an adjunct to prostate specific antigen in the detection of clinically significant prostate cancer. Select Format Select format. Centers for Disease Control and Prevention.

Low bone density in patients receiving methadone maintenance treatment. Case-control and zociety studies have not shown a consistent increase in the risk of venous thromboembolism VTE with T treatment 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. It is possible that T is a marker of health, and those who are at higher risk of dying have lower T concentrations. Int J Clin Pract.

Assessing anterior pituitary function, if clinically indicated, can uncover other pituitary hormone deficiencies. Men emdocrine symptoms potentially consistent with hypogonadism are frequently encountered in clinical practice. Serum T concentrations in some T-deficient men may be in the low-normal range; these men may need applications of two patches daily; skin irritation at the application site occurs frequently in many patients.

  • T administration significantly increased volumetric and areal BMD and the estimated strength of trabecular and peripheral bone in the spine as well as hip

  • Similarly, the detection of a prostate nodule or an induration may indicate an unrecognized cancer.

  • Formulation-specific adverse effects. Adverse health consequences of performance-enhancing drugs: an Endocrine Society scientific statement.

  • Table 8.

  • Requires IM injection; peaks and valleys in serum T concentrations that may be associated with fluctuations in symptoms. Causes of primary hypogonadism include Klinefelter syndrome KScryptorchidism, some types of cancer chemotherapy, radiation to the testes, trauma, torsion, infectious orchitis, HIV infection, anorchia syndrome, and myotonic dystrophy 5.

  • T therapy can cause fluid retention and edema and potentially worsen edema associated with heart failure or other edematous states.

Check endocrine society male hypogonadism guidelines at baseline, 3—6 mo after starting treatment, and then annually. Managing the underlying conditions, such as obesity, may have additional health benefits. Common drug-related adverse events include acne, oiliness of skin, and breast tenderness Table 8. Nearly all opioids in doses equivalent to 30 mg of methadone suppress endogenous T production, although longer acting opioids induce greater and more sustained suppression of T concentrations.

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However, recommendations necessarily reflect the experience, interests and standard operating procedures of the specialty concerned and, hence these guidelines are not always consistent with each other in key areas. One group meeting, several conference calls, and e-mail communications facilitated consensus development. Advanced practice in endocrinology nursing. Both ES and AUS recommend monitoring Hct after 3 to 6 months of testosterone initiation and annually thereafter; sensibly recommending that the testosterone dose be reduced should erthrocytosis begin to develop. Am J Med. Diagnostic threshold: what should the serum T cut-off be for the diagnosis of MH? Measuring bioavailable T concentrations using ammonium sulfate precipitation is technically challenging.

Cardiovascular risks of exogenous testosterone use among hypogonadism guidelines hypoognadism systematic review and meta-analysis. Because of the high prevalence of subclinical prostate cancer in older men, more prostate biopsies in men receiving T therapy would lead to the detection of a greater number of subclinical prostate cancers. Additionally, no RCT was of sufficient size to evaluate risk. Some case reports have suggested that the risk for VTE may be increased in the presence of thrombophilia even without a raised hematocrit, especially within the first 6 months after starting T therapy —

The task force commissioned two systematic reviews and used guifelines best available evidence from other published systematic reviews and individual studies. Pharmacokinetic Profile. Many men with secondary hypogonadism have potentially reversible or treatable causes of gonadotropin suppression and low T concentrations or functional secondary hypogonadism [ e. Type 2 diabetes mellitus and testosterone: a meta-analysis study. Table 2.

J Bone Miner Metab. Overall, short-term 3 to 6 months T use endocrine society male hypogonadism guidelines HIV-infected men 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. All studies were placebo-controlled trials that used randomization or allocation-by-minimization with a low risk of bias. Position statement: utility, limitations, and pitfalls in measuring testosterone: an Endocrine Society position statement. T therapy improves the positive and reduces the negative aspects of mood, but the magnitude of the effect of T on mood in older men is small 61 ,

Despite this attenuation of the diurnal rhythm in older men, a substantial guidelinss of to year-old men who have low serum T concentrations in the afternoon will have normal T concentrations in the morning 9. Androgens and coronary artery disease. However, these studies have not shown consistent improvements in gait speed or measures of disability 6879— Anabolic steroids for the treatment of weight loss in HIV-infected individuals.

Clinicians should measure FT using the equilibrium ,ale method performed under standardized conditions. 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. Patient characteristics associated with testosterone prescribing in the Veteran Affairs system: a cross-sectional study. Ann Intern Med. Table 4.

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