TESTOSTERONE THERAPY.

Doctors are only allowed to prescribe testosterone for medical reasons.

Testosterone replacement Therapy - Does it need treating, risks & types of therapy.

Testosterone Therapy

The majority of men attending the clinic for an opinion regarding TRT do not meet medical criteria for TRT. If you are seeking testosterone prescriptions without an underlying medical disorder then please ask your GP to refer you to an endocrinologist.

The primary purpose of the men’s health clinic is to provide high quality medical advice in keeping with current medical practice. This area of medicine is tightly regulated. As an APHRA registered medical practitioner, any prescription of Testosterone is strictly for therapeutic purposes in accordance with Australian & international guidelines.

In addition, medicare restrictions introduced in 2015 for testosterone therapy mean that the scripts may not be subsidised by the Australian Government (PBS).

** Please read The FAQs at the bottom of the page prior to making an appointment **

The following overview of testosterone replacement therapy is gleaned from a wide variety of up to date sources published in recent medical journals & clinical guidelines and is provided for information purposes.

What are the symptoms of Low Testosterone?

The following symptoms of low testosterone are common at The men’s health clinic. These symptoms are generally common and often due to medical conditions other than androgen deficiency. The following list is not exhaustive:

  • Reduced libido – the desire to have sex
  • Reduced erections (eg. early morning). Erectile dysfunction may be associated.
  • Reduced Body hair & Reduced need for shaving
  • Breast discomfort or largement (gynaecomastia)
  • Sweats or hot flushes

Reduced energy and low mood may be linked to low testosterone although these symptoms are very common anyway so that any link to a low testosterone level may be coincidental. Lack of energy or activity, and stress, may cause low testosterone. Low testosterone is also linked to obesity.

Treating guys with normal testosterone with TRT is essentially illegal for the doctor, and probably more so since Testosterone became a class 1 drug in Queensland in 2014. In any case, there are definite risks which are well described.

What are the causes of Low Testosterone?

Low Testosterone is either:

  • Primary: Testosterone is not produced in enough quantity by the testicles. Common examples are a previous testicle infection, trauma, or genetic conditions such as Klinefelters syndrome or Y microdeletion. The FSH/LH is normally high.
  • Secondary: The pituitary hormone LH normally is produced in sufficient amounts to stimulate the testicles to produce testosterone. The LH levels may be insufficient to do this job, resulting in low testosterone.

There are a large range of conditions that may cause the secondary type. By far the most common are obesity, Diabetes, Sleep apnoea, and longstanding opioid medication. Other conditions include growths on the pituitary gland, Haemochromatosis, chronic kidney disease, and anorexia.

You can also think of the “cause” of low testosterone as either a disease process – called hypogonadism, or as a sluggish endocrine system – called functional. Clearly, medical conditions should not be missed eg.  pituitary tumour, haemochromatosis or klinefelter’s syndrome. Hypogonadism also responds better to TRT than functional testosterone deficiency.

How is the testosterone level checked?

Levels change markedly at different times of day and with or without food. Testosterone levels should be checked in the morning (between 8am and 10am) and fasting.

Low levels should be confirmed on at least one repeat test because measurements taken on different days may vary by up to 30% (for this reason, it’s a requirement that medicare testosterone scripts are based upon proven low testosterone on different days).

The blood testosterone level is the total testosterone. Testosterone is carried by a protein called Sex Hormone Binding Globulin (SHBG). A low SHBG (eg. caused by obesity) will mean that more of the testosterone is in the active free testostonone & it is the free testosterone level that is generally most informative.

A diagnosis of low testosterone should never be based on one sample, and the test should be done fasting and around 0800.

What are the levels of normal testosterone?

Blood testosterone levels vary gradually from low to high. So any definition of low testosterone is going to have a best-guess element to it. There is no absolute cut off between low and normal testosterone. Furthermore, the “reference range’ (normal range) is taken from a male age 2o to 40 years of age. Testosterone levels go down by approximately 1% per year. There is an argument for for the “normal ranges” being age-specific rather than single normal range.

A  testosterone of 9 or 10 is on the low side for a younger adult male. On the other hand, a testosterone level of 9 or 10 is probably acceptable for a male over 70. It’s essential to put put the testosterone level into the whole clinical picture – age, symptoms, weight & medical history.

The Pharmaceutical Benefit Scheme (PBS) allows for prescriptions under medicare. The PBS criteria requires the total testosterone to be less than 8 (with symptoms and signs of androgen deficiency). Testosterone less than 8 is a reasonable figure to distinguish low from normal testosterone but it’s far from the whole story.

Anabolic Steroids push down the measured testosterone level & cause other abnormalities in the blood tests. Testosterone therapy must be avoided to avoid serious complications.

A testosterone level of 9 or 10 is probably acceptable for a male over 70

What are the possible benefits of Testosterone Replacement Therapy?

There is evidence that TRT in men with proven androgen deficiency may:

  • improve muscle strength
  • increase libido
  • reduce body fat
  • Increase Bone Density

These benefits have been demonstrated from trials of Testosterone therapy on men with clinical hypogonadism (symptoms and signs of low testosterone caused by medical conditions).

What about older guys?

This is where it gets more controversial! A landmark study published in the NEJM in 2016 looked at TRT in men age over 65 with a low testosterone. Men were randomly recruited through mass mailings. Men were suitable for the trial if they were over 65 years and did not have things like high blood pressure or severe depression. The men were then tested for low testosterone. The cut-off in the trial was a testosterone level, translated into Australian units, of under 8 nmol/l.  Low levels were repeated. Just under 15% of men had 2 x testosterone levels under 8 nmol/l, and these guys entered the study.

The study was actually 3 studies in 1. In total,  790 men participated in the trial. They were divided into 3 study groups: sexual function, physical function, and energy levels.

Half the men were treated with testosterone gel, and the other half with a placebo gel. Naturally, the men didn’t know which gel they were getting.

What were the results? In those treated with testosterone:

  • Libido and erection scores improved.
  • Energy Levels did not improve significantly – except when the 3 groups were analysed together.
  • Physical function also improved only when all 3 groups were analysed together.

The study is crammed full of statistics. The bottom line is that there is a modest improvement in sexual performance, and there may be an improvement in physical function or vitality. Results were better when testosterone levels was kept in the upper end of the range.

Australian Society of Autralia included the above trial in their 2016 position statement. In terms of older guys, the main take-home message from their position statement is that many older men with low testosterone have obesity, Type 2 Diabetes or other medical conditions. The society (along with other major guidelines) advocate treating these conditions in order to improve the testosterone.

No-one would disagree with this. The problem is that a significant number of men are unable to sustain long term weight loss without surgery. In the ideal world, the weight should be lost. In terms of TRT, it has to be added that most (62%) of the men in the above testosterone trial had obesity.

What are the risks of Testosterone Replacement Therapy?

There are risks of TRT that are known and/or debated and the following risks are the most important ones.

Cardiovascular Disease risks.

Low Testosterone is associated with an increased risk of cardiovascular disease. However, it is unclear whether this is cause or association. It is currently unknown whether TRT will lower the risk of cardiovascular disease.

There is evidence that TRT might increase the risk of cardiovascular disease particularly when the levels are maintained at the higher end of the normal range.  An observational study of pre-existing data in 2014 suggests a doubling of risk of cardiovascular disease in men on TRT who are over 65 years of age. However, this sort of study and others like it are prone to bias. A randomised controlled trial in 2010 of TRT in over 65 year old men had to be stopped early because of a higher risk of cardiovascular events in men on TRT – although the target testosterone in this trial was high-normal at around 17 to 34. On the other hand, the testosterone trial discussed above did not find any increased Cardiovascular risk in the men treated with TRT.

It is certainly prudent, however, to monitor cardiovascular risk in men on TRT – and to aim for a low-normal to mid-normal range.

Prostate Cancer

The prostate gland may be smaller in men with low testosterone. TRT may increase the size of the prostate back to a normal level. Prostate cancer is screened for using the PSA (not a great prostate cancer test but the best widely available medicare subsidised  blood test there is). The PSA goes up when the prostate gland increases in size. Therefore, TRT may increase the PSA level. There is no proven increased risk of prostate cancer with TRT based on the data available. The testosterone trial published in 2016 provides further reassurance.

Sleep Apnoea

TRT may exacerbate sleep apnoea.

Raised Haemoglobin levels

Haemoglobin is the oxygen-carrying protein in red blood cells. Testosterone therapy may increase the number of red blood cells which causes a rise in Haemoglobin. An increase in the concentration of red blood cells makes the blood more “sticky” than normal. More sticky blood increases the risk of aterial blood clots which may cause stroke. The Haemoglobin and concentration of red blood cells is monitored during TRT to ensure these remain within safe levels.

Fertility

Testosterone therapy for “low T” (low testosterone without any disease process) may reduce fertility. On the other hand, TRT may improve fertility in someone with hypogonadism.

Coming off Testosterone

TRT reduces the production of “natural” T from the leydig cells in the testicles. In effect, the testicles can “shrink” with TRT – and it can take several months for the testicles to function when the testosterone therapy is stopped. It will take longer for recovery when testosterone has been taken for a long time, and/or in high doses.

What are the different types of Testosterone Replacement Therapy?

The different types of TRT are broadly injections and topicals. All of these listed treatments are available under medicare (provided the medicare restrictions are met).

The intramuscular injections are either short acting (eg. Primoteston every 3-4 weeks or so) or long acting (eg. Reandron every 12 weeks or so)

The topical treatments are a convenient way of taking TRT and include:

  • Testogel:  Gel that is rubbed into the torso or shoulders
  • Androderm: Patch applied to back, stomach, thighs or arms
  • Axiron: Solution that is applied under the arms similar to a roll-on

Topical treatments may cause skin reactions (particularly the gel and patch) & may be transferred to your partner (gel). Private scripts are more expensive than injections.

The costs of therapy

Medicare raised concerns regarding over-prescribing of testosterone therapy that led to a change of rule in 2015. PBS-subsided prescriptions are subsidised by medicare and now only available for testosterone therapy that is prescribed by a sub-specialist (usually an endocrinologist). There are strong arguments for and against this change of policy, not least the raft of detailed national and international guidelines regarding testosterone therapy. The issue seems to be that some doctors were prescribing testosterone outside of the guidelines.

Approximate pharmacy prices for private prescriptions are typically over $80 per month for topicals, or around $35 per month for injections.

Here’s the lowdown. The practice of your GP (and indeed endocrinologist) should be in line with very detailed guidelines available. When the testosterone is indicated and prescribed by your GP then you will pay privately for the script. For the majority of men who are non concession-card holders, the injections will be around the same price they were before. The price of topical therapy will however be considerably more expensive. Clearly, men who require treatment are likely to opt for private scripts for injections from their doctor which is cost-effective, or be referred for consideration of topical testosterone.

 What monitoring of Testosterone replacement is required?

  • Symptom Check: is it helping? Therapy takes 1 to 3 months to help. Usually stop testosterone therapy by 6 months if no improvement in symptoms. Are there any side effects?
  • Testosterone Blood level: Aim for low-normal to mid-normal adult range. For topical treatments, the level is checked 1-2 weeks following any dose change at the time of day that depends on the brand being used.
  • Blood tests: check Haemoglobin, PSA & Lipids/Glucose every 6-12 months

There are other checks that may be indicated: Bone density and sleep studies for example. Guidelines generally advocate an annual prostate exam in the over 50’s taking testosterone.

Symptoms of low testosterone take around a couple of months to improve following replacement therapy.

The aim is to improve symptoms and signs, and not to put the testosterone into a specific range. The therapy should be stopped if there is no improvement following several months of therapy.

Usually stop testosterone therapy by 6 months if no improvement in symptoms

What about my weight?

weight loss of around 10% in obese men results in an increase in the testosterone level of around 2-3. Major weight loss can increase testosterone levels by more than 10.