© The Canadian Journal of Urology™; 19(Supplement 1); October 2012
GREENSPAN AND BARKIN
24
article, “Testosterone therapy in men with androgen
deficiency syndromes: an Endocrine Society clinical
practice guideline”
41
and aCanadian article, “Apractical
guide to diagnosis, management and treatment of
testosterone deficiency for Canadianphysicians.”
34
Both
articles provide extensive evidence-based information
about TDS.
To diagnose TDS, the authors recommend that
first, total testosterone levels should be determined
in two different early-morning serum samples.
When results of these tests establish that the patient
has low testosterone, follicle stimulating hormone
(
FSH) and luteinizing hormone (LH) levels should be
determined. Before a patient receives TRT, he should
have a baseline complete blood count (CBC) test and
he MUST have a prostate-specific antigen (PSA) test.
More sophisticated testing to determine bioavailable
testosterone and/or calculated free testosterone can
be done when TDS is suspected. Total testosterone
measurements alone are non-diagnostic or equivocal.
However, free testosterone, which may be offered in
many labs, should not be requested, since it is generally
inaccurate and imprecise.
As well as undergoing these blood tests, patients
with suspected TDS can be asked to fill in theAndrogen
Deficiency in Ageing Males (ADAM) screening
questionnaire.
3
This is a ten-item survey with yes/no
answers. Answering “Yes” to questions 1 and 7, or any
3
other questions is suggestive of TDS.
Treatments for TDS
Prior to prescribing TRT for a patient, the physician
needs to be aware of contraindications for this therapy.
TRT is absolutely contraindicated in men who have
been previously diagnosed with breast cancer or
prostate cancer (untreated), and TRT may worsen
erythrocytosis, untreated obstructive sleep apnea, and
severe congestive heart failure. TRT should be used
with caution in men who may become fathers, since it
may lead to infertility.
34
Alternatives to treatment with testosterone in this
situation are off-label use of clomiphene, or use of
human chorionic gonadotrophin (HCG).
The goals of treatment are symptom improvement
and restoration of testosterone to physiological levels.
The acronym ASTEP—which stands for Availability,
Safety, Tolerability, Efficacy, and Preference—can be
used to guide treatment choices.
Types of testosterone
Therapeutic forms of testosterone include injections,
oral capsules (not available in the United States),
transdermal patches, transdermal gels, and sustained
release subcutaneous pellets, see Table 3.
Testosterone injections.
There are two available forms:
testosterone cypionate (Depo-testosterone) 100mg/mL
and testosterone enanthate (Delatestryl) 200 mg/mL.
The usual dosage of injectable testosterone is 1mL-2mL
every 2 weeks. If the response is good, the ultimate
goal is to titrate the dosage so that the patient receives
one injection per month. There are “peaks and valleys”
with intramuscular (IM) administration with the
possibility of “super-physiologic” levels occurring
2
to 4 days after injections. This may result in a slightly
higher incidence of polycythemia compared to other
forms of treatment. This is, by far, the cheapest method
of TRT. “In our opinion, no patient can be considered
a TRT failure unless they have tried injections.”
Oral testosterone therapy.
Testosterone undecanoate
(
Andriol) oral capsules have been available for over
20
years. Capsules are available in a 40mg format. The
suggestedstartingdosage is 80mg, twice aday (160mg/
day). Subsequent dosing (40 mg/day-120 mg/day)
should be based on response. The capsules must be
taken with food (ideally a fatty food, because the drug
is bound to long-chain fatty acids, and this will allow
for better absorption) or absorption does not occur.
With this therapy, blood levels of testosterone fluctuate
and peak levels are often difficult to measure.
Transdermal testosterone patches.
The testosterone
patch (Androderm) is usually applied to the back,
upper arms, thighs or abdomen. Skin irritation, pruritis
or rash at the application sites is more commonly seen
with the patch (than with gel formulations). It is
important to rotate the application site with an interval
of 7 days to reduce the risk of skin irritation.
Transdermal testosterone gels.
There are several
types. AndroGel 1% testosterone gel is available in
a metered-pump bottle (1.25 g of gel per actuation)
or in sachets containing 2.5 g or 5 g of gel (delivering
25
mg and 50 mg of testosterone, respectively). The
usual starting dosage is 5 g daily. The gel is applied
to the shoulders, upper arms or lower abdomen. The
patient can expect to see stable, physiologic blood
levels of testosterone within 4 weeks. The difference
is that the Gel is absorbed and disappears. No visible
evidence of the application is left. The patient is able
to swim a few hours later if desired.
Testim 1% testosterone gel is supplied in 5 g tubes
(
delivering 50 mg of testosterone), andmay be applied
to the shoulders and/or upper arms. The starting
dose is one tube (5 g) daily. The perception is that it is
thicker than the gel and a little more odorous. It is not
clear. Neither complaint is usually significant enough
to instigate patient withdrawal from the medication.
