Treatment of hypogonadism

Guidelines for the treatment of hypogonadism

Please find below the issued recommendations on the diagnosis and management of hypogonadism which may support you in your clinical practice.

Man in his late middle age doing a bicep curl as a sign of strength

British Society for Sexual Medicine (BSSM) 2017

Review summary [1]

  • Clinical diagnosis
    Diagnosis of hypogonadism requires the presence of characteristic signs and symptoms as well as confirmed low levels of serum testosterone or free testosterone. Testosterone should be measured in the morning when the individual has been fasting, between the hours of 8am and 11am.
  • Screening should include:
    - All adult men displaying multiple, consistent symptoms of hypogonadism
    - All men presenting with erectile dysfunction, low sexual desire and loss of spontaneous erections
    - All men type II diabetes, BMI >30 kg/m2 or waist circumference >102cm
    - All men on long-term opiate, antipsychotic or anti-convulsant medication
  • Thresholds for testosterone therapy
    The guidelines for the initiation of therapy are as follows:

    - Total testosterone (TT) levels < 8 nmol/L or free testosterone (FT) levels < 180 pmol/l based on 2 separate readings taken between 8am and 11am indicates requirement of testosterone replacement therapy (TRT)
    - TT > 12 nmol/l or FT >225 pmol/l does not require TRT
    - TT between 8 nmol/l and 12 nmol/l may require TRT and a trial may be warranted for a minimum of 6 months based on the individuals symptoms

    Further recommendations and considerations include:

    - Increased luteinizing hormone (LH) levels and testosterone levels below the normal range may indicate testicular failure so TRT should be considered - increased LH in men with normal testosterone levels but who are displaying symptoms to hypogonadism should be considered as having a testosterone deficiency
    - The guidelines note that recent data indicate clinical symptoms of hypogonadism are more closely related to calculated FT
  • Hypogonadism and fertility issues
    TRT is contraindicated for those who are actively trying to conceive a child. Exogenous testosterone reduced endogenous testosterone levels leading to fertility impairment in some cases. In which instance, it is recommended that the patient be treated with hCG, especially in men with low gonadotropins to stimulate production of testosterone. The guidelines highlight that as there is a lack of information on longer-term treatment with hCG, treatment is only recommended in patients in whom fertility treatment is indicated.
  • Initiation of therapy considerations and contraindications
    Pre-initiation considerations are outlined as below:

    - Cardiovascular, prostate, breast and haematological assessments should be carried out before initiation
    - Cardiovascular risk factors should be assessed
    -TRT can be offered to men with treated localised low-risk prostate cancer* and who have no evidence of active disease
    - Advantages and disadvantages of different TRT options should be considered beforeinitiation as well
  • BSSM identified benefits
    - Improved sexual function, desire and satisfaction
    - Reduced BMI and waist size
    - Therapy shows improved lipid profile, glycemic control, body composition, bone mineralization and features of metabolic syndrome
    - It is recommended that TRT trials are at least 6 months in length and maximal benefits is seen post 12 months

The European Association of Urology (EAU) 2020

Review summary [2]

  • Clinical diagnosis
    Diagnosis of hypogonadism requires the presence of characteristic signs and symptoms as well as confirmed low levels of serum testosterone or free testosterone. Testosterone should be measured in the morning when the individual has been fasting, between the hours of 7am and 11am. Two independent samples should be taken for confirmation of diagnosis.
  • Screening
    Screening recommendations are as follows:
    - Deficiency should be screened for only in men who display consistent and multiple signs and symptoms of deficiency
    - Young men with testicular dysfunction and men older than 50 years of age with low testosterone should also be screened for osteoporosis
  • Initiation of therapy considerations and contraindications
    Contraindications for TRT include male breast cancer, locally advanced or metastatic prostate cancer, men with an active desire to have children, severe chronic cardiac failure and/or a haematocrit >0.54%
  • Hypogonadism and fertility issues
    TRT is contraindicated for those who are actively trying to conceive a child. Exogenous testosterone reduced endogenous testosterone levels leading to fertility impairment in some cases. In which instance, it is recommended that the patient be treated with hCG, especially in men with low gonadotropins to stimulate production of testosterone. The guidelines highlight that as there is a lack of information on longer-term treatment with hCG, treatment is only recommended in patients in whom fertility treatment is indicated.
  • Follow-up
    It is recommended the first follow-up following initiation should take place three months post-initiation. Further evaluation can be carried out at six months or twelve months, according to patient characteristics as well as results of biochemical testing

References

1.  Hackett G, Kirby M, Edwards D, et al. British Society for Sexual Medicine Guidelines on Adult Testosterone Deficiency, With Statements for UK Practice. The journal of sexual medicine. 2017;14(12):1504-1523.
2.  Salonia A, Bettocchi C, Carvalho J. EAU Guidelines on Sexual and Reproductive Health. 2020.

*Defined as a Gleason score <8, stages 1–2, preoperative prostate-specific antigen (PSA) level <10 ng/mL, and not starting before 1 year of follow-up. [1]
FT = Free testosterone, hCG = human chorionic gonadotropin, LH = luteinizing hormone, PSA = prostate specific antigen, TRT = testosterone replacement therapy, TT = total testosterone.

PROMO_1496 Date of Preparation: August 2022