Managing Hypogonadism in
the Primary Care Setting
Dr Michael Gillman
St Andrews Hospital Specialist Suites, Wickham Terrace
Mater Private Clinic, South Brisbane
Shore Street West Medical Centre, Cleveland
1
Hypothalamic – Pituitary – Testicular Axis
Primary Testicular Failure
• Klinefelters
• Bilat Orchidectomy
• Radiotherapy, Chemotherapy
• Cryptorchidism
• Testicular Injury
• Orchitis
• Age
• Co-Morbid conditions particularly Diabetes,
Metabolic Syndrome
3
Secondary ( Hypogonadotrophic )
• Pituitary Tumours
• Haemachromatosis
• Thalassaemia
• Sleep apnoea
• Other acute or chronic illness affecting
hypothalamic-pituitary-testicular axis
• Substance abuse ( steroids and opiates )
4
Presentation (1)
Often picked up incidentally
• Reduced sense of general wellbeing;
• Energy Loss;
• Fatigue;
• Low mood or depression;
• Irritability;
• Poor concentration;
• Poor memory;
5
Presention Continued
• Decreased Libido
• Failure to conceive
• Sexual Dysfunctions
• Losing strength and muscle mass
6
Further History
• History of onset
• Past Medical and Surgical History
• Social and Lifestyle History
• Family History
• Sexual History
• Ask about symptoms of sleep apnoea
• Ask about LUTS
7
Examination
• Height Weight and Waist Circumference
• Testicular examination
• Breast Examination
• Body Hair distribution
• Muscle Mass
• DRE
• General examination BP Heart chest abdomen
etc
8
Investigations
• FBC, E/LFTs, HDL/LDL, serum ferritin, TSH,
serum testosterone, PSA ( Total T more
reliable than free T )
• If Testosterone is low repeat along with LH
and PRL
• Take total T between 8 to 10 a.m.
 The patient should be fasting as glycaemic load can
distort the results
 Avoid prior exhaustive physical exercise (e.g. jogging)
as this may influence the testosterone levels
• ? Sleep Study if suggested by history
• BMD
9
What level of T is hypogonadism?
• Australia: PBS guidelines - Approved indications
for authority:
• Androgen deficiency in males 40 years and older
without pituitary or testicular disorders other than
ageing confirmed by x2 early morning total T <
8nmol/L or 8 -15 nmol/L with high LH (>1.5
times upper limit of normal for young men)
• Androgen deficiency in males with established
pituitary or testicular disorders
• Androgen deficiency in males under 18 years of
age: Micropenis, pubertal induction, or constitutional
delay of growth or puberty
Handelsman (2004)
What are the correct levels for Diagnosis?
•Australia <8 nmol/L
•US <10.4 nmol/L
•Europe <12 nmol/L
Management
• Diet, exercise and waist loss
• T levels may be restored by weight loss with a diet and
exercise program
• Attempt weight loss along with TRT and if successful,
assess need to decrease or cease TRT (3 to 6 months
for function to return)
• Correct other risk factors and co morbid
conditions;
12
Management
• Examine for contraindications for TRT:
• Prostate or breast cancer
• Erythrocytosis ( HCT > 55% )
• Sleep apnoea
• Severe LUTS
• Cardiac failure ( Potential for oedema and
raised HCT )
If Decide to treat
• Explain the probability that this will be long
term therapy
• Explain infertility consequences
• Commence with short acting topical
14
TRT – Topical
(less likely to have negative effects on lipids, less likely to cause polycythaemia)
Androderm
patch
(testosterone +
absorption
enhancers)
Transdermal patch 2.5 & 5 mg – apply 10 p.m. back,
arm, shoulders, abdomen, buttocks, thighs - 1 week
between sites
Mimics normal circadian rhythms
Check T level in a.m. after p.m. patch applied
Contact dermatitis 10-60% , visibility, poor adherence,
difficulty achieving adequate T concentrations
Testogel
(testosterone)
50mg testosterone in a 5 g sachet
Apply daily in a.m. - 5 to 10 g/day - titrate dose by 2.5 g
increments after day 7 (max 10g = 100mg T)
Apply to shoulders, arms, abdomen - wash hands
Allow to dry 3 - 5 mins
Steady state serum T over 24 hours
Lack of visibility and less skin irritation
Dosage flexibility
Take T level 6 to 8 hours after application
Skin transfer - cover or bathe (4 - 6 hours after
application)
Follow up at six weeks
• Assess total T level and adjust dose
• Ask about side effects, voiding symptoms
• Side effects:
• Male pattern hair loss
• Worsening of sleep apnoea
• Acne and oily skin
• Gynaecomastia
• Fluid retention and oedema
• Polycythaemia
• Testicular shrinkage and decreased sperm
count
16
TRT - imi injections
Reandron
1000
(T undeconoate)
imi not for men
with bleeding
disorder or on
anticoagulants
4 ml deep gluteal imi slowly @ 0 and 6 weeks (loading dose)
then every 10 to 14 weeks (x4 per year)
Check T level @ 30 weeks prior to injection 4
Titrate dose by altering timing of injections - administer more
often if T level is below normal
Trough levels within normal range
More stable levels of energy, mood and libido
Less polycythaemia
Primosteston
every 3 weeks
depot
Reandron
1000
every 3 months
@ 3 months, 6 months then annually
• Assess response to Rx
• Assess Total T level
• Hb and HCT (>54%)
• LFT, lipids, voiding symptoms
• Sleep apnoea
• Weight, WC and BMI
• Breast examination
• DRE and PSA – assess velocity
• (BMD each 2 years)
18
Axiron
Not yet approved for use in
Australia or New Zealand
This information is provided in response to your request and is intended for your scientific and/or educational purpose
and is not intended for promotional use. This material is copyrighted by Lilly USA, LLC with all rights reserved.
Background
♦ Aim of testosterone topical solution clinical
program was to develop a topical solution that
would restore total testosterone levels to the
normal range (300-1050 ng/dL)
• Applied using an applicator
• Applied to a discrete anatomical location (underarm)
Data on file, Lilly Research Laboratories, AXSEP2010A
Delivery System
♦ The design hypothesis for this delivery system
was that the solution would be applied onto the
skin of the axilla by use of the flexible silicone
applicator
♦ The product is applied via a metered-dose pump
which is used to deliver a consistent amount of
testosterone solution to the applicator system,
which is then used to apply the dose to the axilla
Data on file, Lilly Research Laboratories, AXSEP2010F
Delivery System

Testosterone topical solution is available as a
metered-dose pump containing 110 mL of
solution
 The pump is capable of dispensing 90 mL of
solution in 60 metered pump actuations

One pump actuation delivers 30 mg of
testosterone in 1.5 mL of solution
AXIRON® (testosterone) solution for topical use CIII [package insert]). Indianapolis, IN: Eli Lilly and Company; 23
Nov 2010
Axillary Application
Dosing and Administration
♦ Recommended daily dose is 60 mg (2 pump
actuations)
♦ Apply to the axilla (clean, dry, intact skin)
♦ Do not apply to any part of the body other than
the axilla
♦ Apply at the same time each day (preferably
morning) following showering/washing
♦ Pump will need to be primed prior to first use
AXIRON® (testosterone) solution for topical use CIII [package insert]). Indianapolis, IN: Eli Lilly and Company; 23
Nov 2010
Dosing and Administration
♦ One (1) pump will dispense 30mg
• If the patient requires a 60mg dose, the application
procedure should be repeated for the other axilla
• If the patient requires the 90mg or 120mg dose, after
the initial application into each axilla, the skin should
be allowed to dry (approximately 3 minutes) prior to
repeating an application on the same axilla or to
dressing
AXIRON® (testosterone) solution for topical use CIII [package insert]). Indianapolis, IN: Eli Lilly and Company; 23
Nov 2010
Dosing and Administration
♦ After use, the applicator should be rinsed with
running water that is room temperature and then
patted dry with a tissue
♦ The applicator and cap are then replaced on the
bottle for storage
♦ Hands should be washed thoroughly with soap
and water immediately after application
AXIRON® (testosterone) solution for topical use CIII [package insert]). Indianapolis, IN: Eli Lilly and Company; 23
Nov 2010
Dosing and Administration
♦ Patients may use antiperspirants/deodorants
with testosterone topical solution
• underarm antiperspirants or deodorants spray or stick
products may be used 2 minutes prior to dose
application as part of normal, consistent, and daily
routine
♦ Patients should be advised to avoid swimming
or washing the application site until 2 hours
following dose application
♦ Patients should cover the axilla application
site(s) with clothing (e.g., a shirt) after the
solution has dried
AXIRON® (testosterone) solution for topical use CIII [package insert]). Indianapolis, IN: Eli Lilly and Company; 23
Nov 2010
Patient Counseling: How to minimize risk
of secondary exposure
♦ Strict adherence to the following precautions is
advised in order to minimize the potential for
secondary exposure to testosterone from
testosterone topical solution treated skin:
• Testosterone topical solution should only be applied
to the axilla, not to any other part of the body
• Children and women should avoid contact with the
unwashed skin of the axilla or unclothed application
sites of men using testosterone topical solution
• Patients should wash their hands immediately with
soap and water after application of testosterone
topical solution
AXIRON® (testosterone) topical solution [package insert]). Indianapolis, IN: Eli Lilly and Company; 23 Nov 2010
Take-home messages
• Consider hypogonadism when patients present
with typical symptoms and signs
• Diagnose hypogonadism and either treat or
refer
• Select patients carefully and monitor closely