© The Canadian Journal of Urology™; 21(Supplement 2); June 2014
Pellets and buccal modalities
Subcutaneous pellets use is rising significantly
and transbuccal agents are a less widely used
formulation. They have unique advantages in
convenience, but major disadvantages as well.
Buccal tablets are associated with gum problems
and bad taste in 10%-20% of treated men.
56
Pellets
need not be reimplanted for 4-6 months, and they
are generally well tolerated,
90
but the implantation
procedure is invasive; infection or pellet extrusion
occurs in 5%-10% of treated men. Implantation
must also be done by an individual so trained in the
procedure.
38
However, the use of this treatment is
growing broadly in the United States and has been
a staple of TRT in Europe for over 12 years.
Oral preparations
Testosterone undecanoate is an oral testosterone
ester delivered by an oily vehicle that escapes hepatic
metabolism through absorption into the lymphatics.
40
It has been used in Europe and Canada for many years
but was never approved for use in the United States.
Its advantages include convenience of administration
and a relatively safe profile, but its short half-life causes
testosterone levels to fluctuate, necessitating multiple
daily dosing.
40,56
The testosterone pharmacokinetic
profile is irregular.
Before initiation of TRT
TRT should not begin without specific steps to assure
safety going forward. The clinician should perform
a baseline digital rectal exam and measure PSA in
patients of all ages to rule out prostate cancer. The PSA
level should be < 4 ng/mL (if age < 50 then total PSA
< 2.5) and should be measured again after 6 months of
TRT regardless of the treatment formulation. Although
hemoglobin and hematocrit levels rarely rise above
normal with most formulations of TRT, they should
be checked at the start of therapy and every 6 months
thereafter. Liver function and lipid levels should also
be evaluated.
39
Monitoring patients on testosterone therapy
Patients on TRT should be evaluated 3-6 months after
the start of treatment and then annually to determine
if symptoms have improved and to check if the patient
is experiencing any adverse effects, Table 6.
11
Since
testosterone frequently stimulates erythropoiesis, a
rise in hematocrit values is not unusual and should be
monitored.
11
Hematocrit values above 54% typically
require cessation of TRT until the values decrease to
a safe level.
11
The Endocrine Society suggests PSA
surveillance in men 40 years and older who have a
baseline PSA greater than 0.6 ng/mL.
11
This means
getting a baseline PSA, another at 3-6 months, and then
afterward at an interval determined by the patient’s age,
race, and risk factors.
11
A urology consult should be
sought if PSArises by > 1.4 ng/mLwithin any 12month
period, if digital rectal examination reveals a prostate
abnormality, or if the IPSS score is greater than 19.
11
Conclusions
Testosterone deficiency is a complex, multi-factorial
disease state that is bi-directionally related to conditions
such as obesity and diabetes that are common in
TABLE 6.
Endocrine Society guidelines for testosterone replacement therapy monitoring
11
Baseline
Every visit
3 months Annually 1-2 years
Symptom response
√
√
√
Adverse events
√
√
√
Formulation-specific AEs
√
Testosterone levels
√
√
Hematocrit*
√
√
√
BMD lumbar/femoral neck
‡
√
√
Digital rectal examination
†
√
√
Prostate-specific antigen
†
√
√
*if hematocrit is > 54%, stop therapy, evaluate patient for hypoxia and sleep apnea, consider reinitiation at reduced dose if levels
have declined to a safe level.
‡
for patients with osteoporosis or low trauma fracture, consistent with standard of care.
†
after 3 months perform in accord with screening guidelines for patient age/race/risk factors.
51
Testosterone deficiency: myth, facts, and controversy
