Mayo Clinic Proceedings



SupplementaryAppendix 1.Appendix 1. Summary of 2010 Endocrine Society Clinical Practice Guidelines3Diagnosis and TreatmentDifferentiate between primary (testicular) and secondary hypogonadism Luteinizing hormone and follicle-stimulating hormone to differentiateIf secondary hypogonadism, consider prolactin assay, pituitary imaging, or iron saturation. Evaluate for chronic opioid or glucocorticoid useIf primary, consider karyotype assessment Consistent signs and symptoms associated with hypogonadismVital to confirm low morning serum testosterone levels in the absence of acute illnessTotal testosterone cut-off of 300 ng/dL recommendedFree or bioavailable testosterone only if borderline total testosterone or expected derangement in sex-hormone binding globulin (SHBG) serum levelsConditions in which SHBG may be significant affected include obesity, liver dysfunction, medical renal disease, thyroid dysfunction, HIV, or diabetes mellitusConsider bone density screening if severe hypogonadismScreening for hypogonadism in general population discouragedConsider screening in patients with known pituitary pathology, HIV, end-stage renal disease, osteoporosis, Type 2 diabetes mellitusTreatmentInitiate treatment only if documented low serum testosterone levels and symptomatic Goal to develop secondary sex characteristics, address sexual dysfunction, quality of life, and bone mineral density *Therapy modalitiesInjectable testosterone enthanate or cypionateTransdermal testosterone patchTestosterone gelBuccal testosterone tabletImplantable testosterone pelletOral or injectable testosterone undecanoate ContraindicationsProstate and breast cancerPSA >4 ng/mL or >3 ng/mL if a high risk patientBaseline hematocrit >50%Untreated severe obstructive sleep apnea *Severe lower urinary tract symptoms (Total Internal Prostate Symptom Score >19) *Uncontrolled or poorly controlled congestive heart failure *A desire for future fertility* Reviewed in systematic analysisMonitoring of TherapyEvaluation, serum total testosterone (goal of mid-normal range), and hematocrit (stop therapy if >54%), digital rectal examination/PSA 3 to 6 months after initiation, then annually thereafter Monitor for sleep apnea and hypoxiaConsider determine bone mineral density in men with osteoporosis or low trauma fractureUrologic consultation if concerning total PSA, PSA velocity, or abnormal digital rectal examination; total International Prostate Symptom Score >19Sexual dysfunction *Among hypogonadal men, treatment with goal to improve low libido and in men with erectile dysfunction, after consideration of “established therapies for erectile dysfunction”*The evidence addressing the effects of testosterone treatment on response to phosphodiesterase type 5 inhibitors are inconclusive*Older Men*Recommend again routine treatment of all older men with hypogonadismEvidence of effects on bone mineral density, depression, and quality of life are inconsistent*Improvements in biometrics are expected *Improvements in grip strength are expected, but evidence examining effects on physical function are inconsistent (most studies excluded men with functional limitations)*The risk of cardiovascular events is not increased by testosterone treatment *Patients with chronic illness and glucocorticoid treated menRecommend treatment3* Reviewed in systematic analysisSupplementary Appendix 2. Study inclusion criteria (PICOS criteria)38100116840Patient populationHypogonadal menInterventionTreatment with testosterone-replacement therapyComparatorPlacebo groupOutcomeTopics covered by 2010 Endocrine Society Clinical Practice Guidelines (e.g., cardiovascular morbidity, mortality, sexual function, lower urinary tract symptoms, sleep apnea, congestive heart failure, prostate cancer, bone mineral density, osteoporosis, quality of life, cognition, erectile dysfunction, adverse events, fertility)Study DesignPlacebo-controlled, randomized, double blind trials published since 201000Patient populationHypogonadal menInterventionTreatment with testosterone-replacement therapyComparatorPlacebo groupOutcomeTopics covered by 2010 Endocrine Society Clinical Practice Guidelines (e.g., cardiovascular morbidity, mortality, sexual function, lower urinary tract symptoms, sleep apnea, congestive heart failure, prostate cancer, bone mineral density, osteoporosis, quality of life, cognition, erectile dysfunction, adverse events, fertility)Study DesignPlacebo-controlled, randomized, double blind trials published since 2010 ................
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