This is an update of previous guidelines published in 2010.
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 involving the patient in decision making.
We 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.
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.
JCEM
Also see:
J C E M
Endocrine Society Guidelines
May 2018
Diagnosis of men with suspected hypogonadism
- We recommend diagnosing hypogonadism in men with symptoms and signs of testosterone deficiency and unequivocally and consistently low serum total testosterone and/or free testosterone concentrations (when indicated).
Monitoring of testosterone replacement therapy
- In hypogonadal men who have started testosterone therapy, we recommend evaluating the patient after treatment initiation to assess whether the patient has responded to treatment, is suffering any adverse effects, and is complying with the treatment regimen.
- We recommend a urological consultation for hypogonadal men receiving testosterone treatment if during the first 12 months of testosterone treatment:
- There is a confirmed increase in PSA > 1.4 ng/mL above baseline
- A confirmed PSA > 4.0 ng/mL, or
- A prostatic abnormality detected on digital rectal examination.
- After 1 year, prostate monitoring should conform to standard guidelines for prostate cancer screening based on the race and age of the patient.
Men with type 2 diabetes mellitus
- In men with type 2 diabetes mellitus who have low testosterone concentrations, we recommend against testosterone therapy as a means of improving glycemic control.
Monitoring of testosterone replacement therapy
- In hypogonadal men who have started testosterone therapy, we recommend evaluating the patient after treatment initiation to assess whether the patient has responded to treatment, is suffering any adverse effects, and is complying with the treatment regimen.
- We recommend a urological consultation for hypogonadal men receiving testosterone treatment if during the first 12 months of testosterone treatment:
- There is a confirmed increase in PSA > 1.4 ng/mL above baseline
- A confirmed PSA > 4.0 ng/mL, or
- A prostatic abnormality detected on digital rectal examination.
- After 1 year, prostate monitoring should conform to standard guidelines for prostate cancer screening based on the race and age of the patient.
HIV-infected men with weight loss
- We suggest that clinicians consider short-term testosterone therapy in HIV-infected men with low testosterone concentrations and weight loss (when other causes of weight loss have been excluded) to induce and maintain body weight and lean mass gain.
Men with type 2 diabetes mellitus
- In men with type 2 diabetes mellitus who have low testosterone concentrations, we recommend against testosterone therapy as a means of improving glycemic control.
Monitoring of testosterone replacement therapy
- In hypogonadal men who have started testosterone therapy, we recommend evaluating the patient after treatment initiation to assess whether the patient has responded to treatment, is suffering any adverse effects, and is complying with the treatment regimen.
- We recommend a urological consultation for hypogonadal men receiving testosterone treatment if during the first 12 months of testosterone treatment:
- There is a confirmed increase in PSA > 1.4 ng/mL above baseline
- A confirmed PSA > 4.0 ng/mL, or
- A prostatic abnormality detected on digital rectal examination.
- After 1 year, prostate monitoring should conform to standard guidelines for prostate cancer screening based on the race and age of the patient.
Older men with age-related decline in testosterone concentration
- We suggest against routinely prescribing testosterone therapy to all men 65 years or older with low testosterone concentrations.
- In men >65 years who have symptoms or conditions suggestive of testosterone deficiency (such as low libido or unexplained anemia) and consistently and unequivocally low morning testosterone concentrations, we suggest that clinicians offer testosterone therapy on an individualized basis after explicit discussion of the potential risks and benefits.
HIV-infected men with weight loss
- We suggest that clinicians consider short-term testosterone therapy in HIV-infected men with low testosterone concentrations and weight loss (when other causes of weight loss have been excluded) to induce and maintain body weight and lean mass gain.
Men with type 2 diabetes mellitus
- In men with type 2 diabetes mellitus who have low testosterone concentrations, we recommend against testosterone therapy as a means of improving glycemic control.
Monitoring of testosterone replacement therapy
- In hypogonadal men who have started testosterone therapy, we recommend evaluating the patient after treatment initiation to assess whether the patient has responded to treatment, is suffering any adverse effects, and is complying with the treatment regimen.
- We recommend a urological consultation for hypogonadal men receiving testosterone treatment if during the first 12 months of testosterone treatment:
- There is a confirmed increase in PSA > 1.4 ng/mL above baseline
- A confirmed PSA > 4.0 ng/mL, or
- A prostatic abnormality detected on digital rectal examination.
- After 1 year, prostate monitoring should conform to standard guidelines for prostate cancer screening based on the race and age of the patient.
Treatment of hypogonadism with testosterone
- We recommend testosterone therapy in hypogonadal men to induce and maintain secondary sex characteristics and correct symptoms of testosterone deficiency.
- We recommend AGAINST testosterone therapy in men:
- Planning fertility in the near term.
- With breast or prostate cancer
- Palpable prostate nodule or induration
- PSA > 4 ng/mL
- PSA > 3 ng/mL + at high risk of prostate cancer (without further urological evaluation)
- Elevated hematocrit
- Untreated severe OSA
- Severe lower urinary tract symptoms
- Uncontrolled heart failure
- Myocardial infarction or stroke within the last 6 months, or
- Thrombophilia.
- In hypogonadal men 55-70 years old, who are being considered for testosterone therapy and have a life expectancy > 10 years, we suggest discussing the potential benefits and risks of evaluating prostate cancer risk and prostate monitoring and engaging the patient in shared decision making regarding prostate cancer monitoring.
- For patients who choose monitoring, clinicians should assess prostate cancer risk before starting testosterone treatment and 3 to 12 months after starting testosterone.
- In hypogonadal men being considered for testosterone therapy who are 40-70 years old and at increased risk of prostate cancer (e.g., African Americans and men with a first-degree relative with diagnosed prostate cancer), we suggest discussing prostate cancer risk with the patient and offering monitoring options.
Older men with age-related decline in testosterone concentration
- We suggest against routinely prescribing testosterone therapy to all men 65 years or older with low testosterone concentrations.
- In men >65 years who have symptoms or conditions suggestive of testosterone deficiency (such as low libido or unexplained anemia) and consistently and unequivocally low morning testosterone concentrations, we suggest that clinicians offer testosterone therapy on an individualized basis after explicit discussion of the potential risks and benefits.
HIV-infected men with weight loss
- We suggest that clinicians consider short-term testosterone therapy in HIV-infected men with low testosterone concentrations and weight loss (when other causes of weight loss have been excluded) to induce and maintain body weight and lean mass gain.
Men with type 2 diabetes mellitus
- In men with type 2 diabetes mellitus who have low testosterone concentrations, we recommend against testosterone therapy as a means of improving glycemic control.
Monitoring of testosterone replacement therapy
- In hypogonadal men who have started testosterone therapy, we recommend evaluating the patient after treatment initiation to assess whether the patient has responded to treatment, is suffering any adverse effects, and is complying with the treatment regimen.
- We recommend a urological consultation for hypogonadal men receiving testosterone treatment if during the first 12 months of testosterone treatment:
- There is a confirmed increase in PSA > 1.4 ng/mL above baseline
- A confirmed PSA > 4.0 ng/mL, or
- A prostatic abnormality detected on digital rectal examination.
- After 1 year, prostate monitoring should conform to standard guidelines for prostate cancer screening based on the race and age of the patient.
Evaluation for determining the etiology of hypogonadism
- In men with hypogonadism, we suggest further evaluation to identify the etiology of hypothalamic, pituitary, and/or testicular dysfunction.
Treatment of hypogonadism with testosterone
- We recommend testosterone therapy in hypogonadal men to induce and maintain secondary sex characteristics and correct symptoms of testosterone deficiency.
- We recommend AGAINST testosterone therapy in men:
- Planning fertility in the near term.
- With breast or prostate cancer
- Palpable prostate nodule or induration
- PSA > 4 ng/mL
- PSA > 3 ng/mL + at high risk of prostate cancer (without further urological evaluation)
- Elevated hematocrit
- Untreated severe OSA
- Severe lower urinary tract symptoms
- Uncontrolled heart failure
- Myocardial infarction or stroke within the last 6 months, or
- Thrombophilia.
- In hypogonadal men 55-70 years old, who are being considered for testosterone therapy and have a life expectancy > 10 years, we suggest discussing the potential benefits and risks of evaluating prostate cancer risk and prostate monitoring and engaging the patient in shared decision making regarding prostate cancer monitoring.
- For patients who choose monitoring, clinicians should assess prostate cancer risk before starting testosterone treatment and 3 to 12 months after starting testosterone.
- In hypogonadal men being considered for testosterone therapy who are 40-70 years old and at increased risk of prostate cancer (e.g., African Americans and men with a first-degree relative with diagnosed prostate cancer), we suggest discussing prostate cancer risk with the patient and offering monitoring options.
Older men with age-related decline in testosterone concentration
- We suggest against routinely prescribing testosterone therapy to all men 65 years or older with low testosterone concentrations.
- In men >65 years who have symptoms or conditions suggestive of testosterone deficiency (such as low libido or unexplained anemia) and consistently and unequivocally low morning testosterone concentrations, we suggest that clinicians offer testosterone therapy on an individualized basis after explicit discussion of the potential risks and benefits.
HIV-infected men with weight loss
- We suggest that clinicians consider short-term testosterone therapy in HIV-infected men with low testosterone concentrations and weight loss (when other causes of weight loss have been excluded) to induce and maintain body weight and lean mass gain.
Men with type 2 diabetes mellitus
- In men with type 2 diabetes mellitus who have low testosterone concentrations, we recommend against testosterone therapy as a means of improving glycemic control.
Monitoring of testosterone replacement therapy
- In hypogonadal men who have started testosterone therapy, we recommend evaluating the patient after treatment initiation to assess whether the patient has responded to treatment, is suffering any adverse effects, and is complying with the treatment regimen.
- We recommend a urological consultation for hypogonadal men receiving testosterone treatment if during the first 12 months of testosterone treatment:
- There is a confirmed increase in PSA > 1.4 ng/mL above baseline
- A confirmed PSA > 4.0 ng/mL, or
- A prostatic abnormality detected on digital rectal examination.
- After 1 year, prostate monitoring should conform to standard guidelines for prostate cancer screening based on the race and age of the patient.
Distinguishing between primary or secondary hypogonadism
- In men who have hypogonadism, we recommend distinguishing between primary (testicular) and secondary (pituitary–hypothalamic) hypogonadism by measuring serum LH and FSH concentrations.
Evaluation for determining the etiology of hypogonadism
- In men with hypogonadism, we suggest further evaluation to identify the etiology of hypothalamic, pituitary, and/or testicular dysfunction.
Treatment of hypogonadism with testosterone
- We recommend testosterone therapy in hypogonadal men to induce and maintain secondary sex characteristics and correct symptoms of testosterone deficiency.
- We recommend AGAINST testosterone therapy in men:
- Planning fertility in the near term.
- With breast or prostate cancer
- Palpable prostate nodule or induration
- PSA > 4 ng/mL
- PSA > 3 ng/mL + at high risk of prostate cancer (without further urological evaluation)
- Elevated hematocrit
- Untreated severe OSA
- Severe lower urinary tract symptoms
- Uncontrolled heart failure
- Myocardial infarction or stroke within the last 6 months, or
- Thrombophilia.
- In hypogonadal men 55-70 years old, who are being considered for testosterone therapy and have a life expectancy > 10 years, we suggest discussing the potential benefits and risks of evaluating prostate cancer risk and prostate monitoring and engaging the patient in shared decision making regarding prostate cancer monitoring.
- For patients who choose monitoring, clinicians should assess prostate cancer risk before starting testosterone treatment and 3 to 12 months after starting testosterone.
- In hypogonadal men being considered for testosterone therapy who are 40-70 years old and at increased risk of prostate cancer (e.g., African Americans and men with a first-degree relative with diagnosed prostate cancer), we suggest discussing prostate cancer risk with the patient and offering monitoring options.
Older men with age-related decline in testosterone concentration
- We suggest against routinely prescribing testosterone therapy to all men 65 years or older with low testosterone concentrations.
- In men >65 years who have symptoms or conditions suggestive of testosterone deficiency (such as low libido or unexplained anemia) and consistently and unequivocally low morning testosterone concentrations, we suggest that clinicians offer testosterone therapy on an individualized basis after explicit discussion of the potential risks and benefits.
HIV-infected men with weight loss
- We suggest that clinicians consider short-term testosterone therapy in HIV-infected men with low testosterone concentrations and weight loss (when other causes of weight loss have been excluded) to induce and maintain body weight and lean mass gain.
Men with type 2 diabetes mellitus
- In men with type 2 diabetes mellitus who have low testosterone concentrations, we recommend against testosterone therapy as a means of improving glycemic control.
Monitoring of testosterone replacement therapy
- In hypogonadal men who have started testosterone therapy, we recommend evaluating the patient after treatment initiation to assess whether the patient has responded to treatment, is suffering any adverse effects, and is complying with the treatment regimen.
- We recommend a urological consultation for hypogonadal men receiving testosterone treatment if during the first 12 months of testosterone treatment:
- There is a confirmed increase in PSA > 1.4 ng/mL above baseline
- A confirmed PSA > 4.0 ng/mL, or
- A prostatic abnormality detected on digital rectal examination.
- After 1 year, prostate monitoring should conform to standard guidelines for prostate cancer screening based on the race and age of the patient.
Screening and case detection for hypogonadism
- We recommend against routine screening of men in the general population for hypogonadism.
Distinguishing between primary or secondary hypogonadism
- In men who have hypogonadism, we recommend distinguishing between primary (testicular) and secondary (pituitary–hypothalamic) hypogonadism by measuring serum LH and FSH concentrations.
Evaluation for determining the etiology of hypogonadism
- In men with hypogonadism, we suggest further evaluation to identify the etiology of hypothalamic, pituitary, and/or testicular dysfunction.
Treatment of hypogonadism with testosterone
- We recommend testosterone therapy in hypogonadal men to induce and maintain secondary sex characteristics and correct symptoms of testosterone deficiency.
- We recommend AGAINST testosterone therapy in men:
- Planning fertility in the near term.
- With breast or prostate cancer
- Palpable prostate nodule or induration
- PSA > 4 ng/mL
- PSA > 3 ng/mL + at high risk of prostate cancer (without further urological evaluation)
- Elevated hematocrit
- Untreated severe OSA
- Severe lower urinary tract symptoms
- Uncontrolled heart failure
- Myocardial infarction or stroke within the last 6 months, or
- Thrombophilia.
- In hypogonadal men 55-70 years old, who are being considered for testosterone therapy and have a life expectancy > 10 years, we suggest discussing the potential benefits and risks of evaluating prostate cancer risk and prostate monitoring and engaging the patient in shared decision making regarding prostate cancer monitoring.
- For patients who choose monitoring, clinicians should assess prostate cancer risk before starting testosterone treatment and 3 to 12 months after starting testosterone.
- In hypogonadal men being considered for testosterone therapy who are 40-70 years old and at increased risk of prostate cancer (e.g., African Americans and men with a first-degree relative with diagnosed prostate cancer), we suggest discussing prostate cancer risk with the patient and offering monitoring options.
Older men with age-related decline in testosterone concentration
- We suggest against routinely prescribing testosterone therapy to all men 65 years or older with low testosterone concentrations.
- In men >65 years who have symptoms or conditions suggestive of testosterone deficiency (such as low libido or unexplained anemia) and consistently and unequivocally low morning testosterone concentrations, we suggest that clinicians offer testosterone therapy on an individualized basis after explicit discussion of the potential risks and benefits.
HIV-infected men with weight loss
- We suggest that clinicians consider short-term testosterone therapy in HIV-infected men with low testosterone concentrations and weight loss (when other causes of weight loss have been excluded) to induce and maintain body weight and lean mass gain.
Men with type 2 diabetes mellitus
- In men with type 2 diabetes mellitus who have low testosterone concentrations, we recommend against testosterone therapy as a means of improving glycemic control.
Monitoring of testosterone replacement therapy
- In hypogonadal men who have started testosterone therapy, we recommend evaluating the patient after treatment initiation to assess whether the patient has responded to treatment, is suffering any adverse effects, and is complying with the treatment regimen.
- We recommend a urological consultation for hypogonadal men receiving testosterone treatment if during the first 12 months of testosterone treatment:
- There is a confirmed increase in PSA > 1.4 ng/mL above baseline
- A confirmed PSA > 4.0 ng/mL, or
- A prostatic abnormality detected on digital rectal examination.
- After 1 year, prostate monitoring should conform to standard guidelines for prostate cancer screening based on the race and age of the patient.