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TESTOSTERONE REPLACEMENT

-What types of testosterone are available in Australia?
-What are the side-effects of testosterone therapy?
-When should testosterone therapy be stopped?
-Who should NOT receive testosterone therapy?
-Does testosterone therapy affect fertility?
-When is other hormone therapy needed?
-Will these drugs affect sporting performance?
-Will testosterone replacement affect penis size?
-Are there other androgen supplements apart from testosterone?
-What other drugs may be offered to men with symptoms of androgen deficiency?
-Are there any herbal products for androgen deficiency?

What types of testosterone are available in Australia?

There are a number of forms of testosterone that are currently available in Australia including:

Patient convenience and familiarity, cost and availability will depend on the type of treatment prescribed.

Commercial testosterone preparations contain only the natural testosterone molecule.  This is chemically produced from plant materials.  In this regard all testosterone therapies can be considered to be natural products.

Testosterone injections (Sustanon®, Primoteston®)

Testosterone injections of 1 ml are given into the muscle, usually the buttock, every two to three weeks, depending upon the dose needed and the response achieved.  Injections of 250 mg are standard treatment, although lower doses (100 mg) may be used.  Some men are sensitive to the wide variations in testosterone levels across the weeks, or they find the injections painful, and other delivery methods should be considered.  As the testosterone is dissolved in an oily base, it should be warmed to room temperature to make injection easier.

Testosterone injections should not be given to men with bleeding disorders, including those men taking anti-coagulants (blood thinning medication).

Long acting testosterone injections (Reandron® 1000)

Very recently a new intramuscular injectable form of testosterone that lasts up to 14 weeks was approved in Australia. This form of testosterone is given as a deep injection into the buttock.  Following the initial injection a second injection is given at 6 weeks and then approximately every 12 weeks thereafter.  The testosterone is released slowly so that men do not experience the peaks and troughs that are common with standard injections. This form of treatment is not appropriate in men who have bleeding disorders (or who are taking blood thinning medication).

Testosterone implants

Small ‘pellets’ (about 1 cm in length and each containing 200 mg of testosterone) can be placed under the skin of either the abdomen or the buttock.  Doctors experienced in this technique must perform the implanting procedure, which is done using local anaesthetic.  Most men will need three or four 200 mg pellets implanted each time.  The implants produce normal testosterone levels in the blood over a long period and last between four and six months.

Unfortunately about 10 per cent of the pellets work their way to the surface of the skin and are eventually pushed out.  Because of the long time of action, implants should be used with caution in older men.

Testosterone patches (Androderm®)

Testosterone is available in patches that are put on at night and work at all times to allow testosterone to be absorbed through the skin. The normal dose is a single 5 mg patch but 2.5 mg patches are also available to allow some dose adjustment. The patches are put on to the back, arms, shoulders, abdomen or buttocks.

About one in ten young men and about one in five older men develop a skin rash when using the patches.  This can sometimes be avoided by changing the place where the patches are put on and/or by the use of a cortisone cream (Aristocort® cream, 0.02 per cent triamcinolone) under the patch.

Capsules - Oral testosterone undeconoate (Andriol®, Andriol Testocaps®)

These 40 mg capsules must be taken with fluid that contains fat (for example, milk) to help the absorption.  One or two capsules are normally taken three times per day.  The testosterone levels gained with this form of treatment usually do not fully replace the testosterone levels and are usually only chosen when a man is unable to handle other forms of treatment.  However, if a man has had low levels of testosterone for a long time, then the capsules may be a suitable way to start treatment slowly.

Testosterone gel (Testogel®)

Testosterone gel, which is rubbed into the skin once a day, is available in Australia and has proved very popular overseas.  When the gel is applied to the shoulders, arms or abdomen, testosterone is absorbed into the skin, which acts as a reservoir. This results in a slow, continuous delivery of testosterone into the bloodstream, at relatively constant concentrations over 24 hours.

Other synthetic androgens

An oral preparation, which is placed inside the mouth (buccal) and absorbed through the membranes lining the gums, is available overseas and is not yet available in Australia.

A testosterone cream preparation (Andromen® cream) is available only in Western Australia.  This cream preparation may not always provide sufficient and constant levels of testosterone because of uneven absorption through the skin.

Some oral preparations (medical lozenges or troches), may be produced by compounding chemists.  However, these are not Government approved and it is not clear how well they work.

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What are the side-effects of testosterone therapy?

Testosterone therapy can increase prostate growth, possibly making any prostate cancer, if present, worse.  Testosterone should not be prescribed for men with prostate cancer.  It may also make symptoms of benign enlargement of the prostate (or benign prostatic hyperplasia, BPH) worse (for example, obstruction of urine flow or a need for urination more often).

Other side-effects are uncommon.  Mild acne, weight gain, breast development (gynaecomastia), male-pattern hair loss and changes in mood (including increased aggression) can happen and should be managed by a doctor.

Sometimes testosterone therapy can increase red blood cells (polycythaemia) leading to problems with blood circulation.  This is more likely to be a problem for older men, particularly if they have sleep apnoea (short periods where breathing stops during sleep, often in men with heavy snoring).

Existing tendencies towards migraines, sleep apnoea or androgen-sensitive epilepsy can also worsen with testosterone treatments.

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When should testosterone therapy be stopped?

If androgen deficiency is confirmed at any age, testosterone therapy will usually be needed for the rest of the man’s life.

However, there are no benefits of testosterone if a diagnosis of androgen deficiency has NOT been proven.  If a man who is not androgen deficient starts testosterone therapy, his body will stop producing its own testosterone.  If he later stops treatment, he may get symptoms of low testosterone for a short time as his testes gradually begin again to make the hormone themselves.  The withdrawal and review of testosterone treatment should be done under medical supervision.

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Who should NOT receive testosterone therapy?

The presence of other medical conditions may influence a doctor’s decision as to whether to treat androgen deficiency with testosterone therapy.

A particular concern of testosterone therapy is the potential worsening of prostate disease.  This treatment should not be started in older men before the possibility of prostate cancer has been considered.  Testosterone may cause the prostate gland and any prostate cancer, if present, to increase in size.

Men with advanced prostate cancer who go through medical or surgical castration (removal of the testes to lower the amount of testosterone made in the body) should not be treated with testosterone (there may be rare exceptions to this).

Testosterone therapy should also not be used to treat low hormone levels caused by other treatable conditions, such as obesity or depression.  These underlying problems should be corrected first as hormone levels may return to normal and testosterone therapy may never be needed.

Testosterone therapy should not be prescribed for men with breast cancer.

Testosterone should only be used in young boys who have not completed natural puberty, with advice from a paediatric endocrinologist.

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Does testosterone therapy affect fertility?

Testosterone treatment generally stops the production of pituitary hormones FSH and LH which normally stimulate the testes.  This reduces the size of the testes and can lower or stop sperm production.  If sperm production was previously normal, it usually recovers several months after stopping treatment.  Androgen deficient men often don’t make sperm and are already infertile before treatment starts.

Testosterone treatment does NOT boost sperm counts and any man with fertility issues must discuss these with his doctor before starting treatment.  Men with low sperm counts wishing to have children may benefit from other hormonal treatments that turn sperm production back on.

more informationMore information: Male Infertility

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When is other hormone therapy needed?

In those men with pituitary hormone deficiency in whom there is no underlying damage to the testes, and who are trying to achieve a pregnancy, treatment with injections to replace the pituitary hormones LH and FSH will be needed for sperm counts to increase.  This treatment will also bring testosterone levels back to normal.  After fertility treatment is complete, these men then are prescribed standard testosterone therapy alone.

Men with pituitary damage may need other hormone treatments such as thyroid hormone or cortisol.

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Will these drugs affect sporting performance?

Replacing testosterone in men with androgen deficiency to bring testosterone levels back to normal will return muscle strength and energy levels.  However, the use of androgens by normal men to improve athletic performance is illegal and presents significant short and long-term health risks.  Men who use anabolic steroids will lower or even turn off their own testosterone and sperm production and it may take many months after stopping anabolic steroids for testosterone levels and sperm counts to return to normal.

more informationMore informationAbuse of androgens

Competitive athletes, who take part in drug screening in their sporting activities, should be warned about the risks of disqualification if testosterone is prescribed for medical treatment.  Special exceptions may be issued by the Australian Sports Drug Medical Advisory Committee for elite athletes who need testosterone treatment for genuine medical conditions (for example Klinefelter’s Syndrome).

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Will testosterone replacement affect penis size?

If testosterone is taken before puberty (under the care of a paediatrician) for the treatment of micropenis in boys, the penis will increase in size. 

If testosterone is given in normal puberty and adulthood, there will be no further change in penis size.

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Are there other androgen supplements apart from testosterone?

Fluoxymesterone and 17-a-methyl testosterone are synthetic androgens.  These may cause liver damage and are not suitable for androgen deficiency treatment.  These may cause liver damage and are not suitable for treatment of androgen deficiency.

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What other drugs may be offered to men with symptoms of androgen deficiency?

Growth hormone supplements have been promoted by some as “anti-ageing” products but no real benefit has been proven1.  The risks of taking growth hormone on a long-term basis are also not known.  Growth hormone is therefore not recommended as a treatment for androgen deficiency.

DHEA (dehydroepiandrosterone) and androstenedione are very weak androgens and do not work well when used to treat proven androgen deficiency.  They are not approved in Australia for treatment of androgen deficiency.

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Are there any herbal products for androgen deficiency?

There are many herbal products marketed, particularly on the Internet, as treatments to mimic the action of testosterone and improve muscle strength and libido. 

However, there are no known herbal products that can replace the role of testosterone in the body and that can be used to treat androgen deficiency.

1 Blackman MR, Sorkin JD, Munzer T, et al. Growth hormone and sex steroid administration in healthy aged women and men: a randomized controlled trial.  JAMA 2002; 288:2282-2292

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  Last updated Thursday, 1 December 2005    
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