What is hypogonadism?
Male hypogonadism is a clinical condition resulting from a failure of the testes to produce physiological levels of testosterone (androgen deficiency), sperm, or both, because of disruption of one or more levels of the hypothalamic-pituitary-gonadal axis.1 Hypogonadism can occur in men of any age, however, there is a progressive decline in testosterone levels as men age. Lateonset hypogonadism (LOH; age-related hypogonadism) is a clinical and biochemical syndrome associated with advancing age and characterised by symptoms and a deficiency in serum testosterone levels below the young healthy adult male reference range of approximately 12–35 nmol/L (300–1000 ng/dL).2,3,4
Unlike the clearly defined decrease in hormone levels associated with female menopause, the decline in androgen levels with advancing age in men is gradual and variable, and the term ‘late-onset hypogonadism’ is more appropriate than the colloquial terms “male menopause” or “andropause” to refer to the annual decrease in testosterone levels of 0.5% to 2% which occur with advancing age, independent of chronic conditions associated with ageing.5
Hypogonadism and testosterone therapy
Fundamental concepts regarding hypogonadism and testosterone therapy:
1. TD is a well-established, significant medical condition that negatively affects male sexuality, reproduction, general health, and quality of life.
TD (low levels of testosterone):
2. The symptoms and signs of TD occur as a result of low levels of T and may benefit from treatment regardless of whether there is an identified underlying cause.
3. TD is a global public health concern.
4. T therapy for men with TD is effective, rational, and evidence based.
High-level evidence shows T therapy may effectively:
Strongly suggestive evidence for improvement in mood and energy
5. There is no T level threshold that reliably distinguishes those who will respond to treatment from those who will not.
No study has revealed a single testosterone threshold that reliably separates those who experience signs and symptoms of TD from those who do not, nor who will likely respond to treatment.
Interpretation of total T levels is confounded by:
Free T can be a useful indicator of androgen status.
6. There is no scientific basis for any age-specific recommendations against the use of T therapy in men.
7. The evidence does not support increased risks of CV events with T therapy.
8. The evidence does not support increased risk of PCa with T therapy.
9. Evidence supports a major research initiative to explore possible benefits of T therapy for cardiometabolic disease, including diabetes.
Abbreviations: CV; cardiovascular; PCa; prostate cancer; RCT; randomised controlled trial; SHBG; sex hormone binding globulin; T; testosterone; TD; testosterone deficiency; VTE; venothrombotic events.
How common is hypogonadism?
* The prevalence of hypogonadism was 33% based on standard normal ranges. However, when the normal range from a study on younger male subjects was used (20-29 years), 58% were subnormal.
How are men affected by hypogonadism?
* Please refer to product SmPC for a full list of special warnings and precautions for use.
Why is it important to treat hypogonadism?
* Please refer to product SmPC for a full list of special warnings and precautions for use
Diagnosis and controversies
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