CONCORD INTERNAL MEDICINE
TESTOSTERONE DEFICIENCY PROTOCOL
Douglas G. Kelling, Jr., MD
Carmella Gismondi-Eagan, MD, FACP
George C. Monroe, III, MD
Revised April 29, 2012
The information contained in this protocol should never be used as a substitute for
clinical judgment.
The clinician and the patient need to develop an individual treatment plan tailored to
the specific needs and circumstances of the patient.
Testosterone Deficiency Protocol
Table of Contents
P
AGE(
S)
I
NITIALE
VALUATION1-5
T
ESTOSTERONET
HERAPY6-12
BPH
S
YMPTOMSI
NDEXQ
UESTIONNAIRE13
E
PWORTHS
LEEPINESSS
CALE14
B
EDP
ARTNER/O
BSERVERS
LEEPINESSQ
UESTIONNAIRE15
Page 1
TESTOSTERONE PROTOCOL
Symptoms of Depression, Decreased Libido, Erectile Dysfunction, Fatigue, Infertility
or Muscle Weakness
Or
Osteoporosis/Osteopenia by DEXA Scan
And
No hospitalization in the last 3 months and no evidence of Class 3 or Class 4 CHF
Draw 8am Total Testosterone
Total Testosterone > 400ng/dl
No further workup Repeat 8am Total Testosterone
Total Testosterone > 400ng/dl Total Testosterone 200-400ng/dl Total Testosterone < 200ng/dl Normal Free Testosterone No further workup
Repeat total testosterone and Measure calculated 8am Free
Testosterone Total Testosterone 200-400ng/dl Low Free Testosterone Total Testosterone <200ng/dl Measure LH and FSH Levels obtain
DEXA scan if not already done No further workup Measure Prolactin Level, TSH and Free T4 See Page 2 Fasting iron, iron binding
capacity and ferritin
Refer to Page 4 Primary Hypogonadism Elevated Values for LH and FSH “Normal Values” for LH and FSH TSAT < 45 TSAT > 45 No further
evaluation Genotype for
hemochromatosis Determine Karyotype (Klinefelter’s Syndrome)
Page 2
Free T4
Normal Age > 50 Age < 50 Total Testosterone > 150 Total Testosterone < 150 Low Refer to Page 3 Total Testosterone > 250 Total Testosterone < 250 Refer to Page 3 MRI of Pituitary MRI of Pituitary shows tumor MRI of Pituitary shows no tumor Refer to Endocrinologist Refer to Page 3Page 3
Prolactin Level
Normal Prolactin Level Elevated TSH Normal TSH Treat for Hypothyroidism Patient on medication which could elevateProlactin Level Refer to Page 16 Once TSH normal Repeat Prolactin Level Normal Prolactin Level Elevated Prolactin Level Hypogonadotropic Hypogonadism Elevated Prolactin Level Yes No If possible switch patient to medication that will not
raise Prolactin level Order MRI of pituitary and refer to Endocrinologist Refer to Page 4
Normal Prolactin Level Remeasure Prolactin level in 3 months
Elevated Prolactin Level Refer to Page 1
Remeasure 8am Total Testosterone
Page 4
Class III or IV CHF
and/or
History of Prostate or Breast Cancer
No Yes No treatment with Testosterone Yes Symptoms of BPH Refer to Page 13 No Symptoms of Sleep Apnea Refer to Pages 14 & 15
for questionnaires Perform DRE and
PVR by Bladder Scan, obtain urinalysis and PSA
then Refer to Urologist
Discuss with urologist if there is contraindications to treatment
with testosterone
Yes
No treatment with
testosterone Refer to Page 5 after questionnaires
Page 5
Symptoms of Sleep Apnea Refer to Pages 14 & 15
Yes Sleep apnea present Sleep apnea not present Treat sleep apnea 3 months Repeat 8 am Total Testosterone Refer to Page 1
Measure baseline PSA, Hct and Liver Profile
Do DRE Sleep Study No Abnormal PSA Normal PSA Hct > 50 Hct < 50 Abnormal Liver Panel Normal Liver Panel Abnormal DRE Normal DRE Refer to Urologist Contraindications to testosterone No Testosterone Add Testosterone Protocol in touchworks in patient’s chart Refer to Page 12
No Testosterone Evaluate before starting testosterone Contraindications to testosterone Yes No Refer to Urologist Contraindications to testosterone Yes No No Testosterone No Yes No Testosterone Testosterone Treatment Refer to Page 6
Page 6
Start or change to Androgel, Androderm 5mg patch or Testim 5G
Measure total serum testosterone level in 14 days
Total testosterone level < 400 Total testosterone level > 700
Refer to Page 11 Refer to Page 8 Total testosterone
level 400-700
Continue present dose of Androgel, Androderm, or
Testim Increase Androgel or Testim
to 7.5G
* Androderm not available in 7.5mg at this time. If possible switch patient to
Testosterone Therapy
Decrease Androgel, or Testim to 2.5G. Androderm to 2.5mg
Page 7
Change Androgel or Testim to 7.5G
Measure total serum testosterone level in 14 days
Total testosterone level 400-700
Total testosterone level > 700
Increase Androgel or Testim to 10 G Total testosterone level < 400
Continue present dose of Androgel/Testim
Decrease Androgel or Testim to 5G
Page 8
Change Androgel, Androderm 2.5mg, or Testim to 2.5G
Measure total serum testosterone level in 14 days
Total testosterone level < 400 Total testosterone level > 700
Refer to Page 11 Increase Androgel or
Testim to 5G, increase Andrederm to 5mg.
Repeat 8 AM total serum testosterone in 3 months Total testosterone
level 400-700
Refer to Page 6
Stop Androgel, Androderm or Testim
Page 9
Increase Androgel or Testim to 10G
Measure total serum testosterone level in 14 days
Total testosterone level 400-700
Total testosterone level > 700
Stop Androgel or Testim and begin IM Testosterone per
protocol-Page 10 Total testosterone level < 400
Refer to Page 11 Decrease Androgel or Testim to 7.5G
Page 10
IM Testosterone Protocol
Testosterone Cypionate 200 mg IM q 2 weeks
Obtain a total testosterone level 7days after the 4
thIM
dose.*
Testosterone level > 700 ng/dl Or < 400 ng/dl Testosterone level < 700 ng/dl Or > 400 ng/dlAdjust dose or frequency Refer to Page 11
*If for patient convenience, lab for testosterone could be pushed to after the 6th dose-to coordinate with recheck of H/H, PSA, DRE, 3 month recheck: notify the patient of risk that if dose is too low or high, there will be a delay in change.
Page 11
Continue Present dose Testosterone
Obtain Hct 3 months after initiation of therapy then
yearly
Hct <54 Hct >54
Continue present dose testosterone
Stop testosterone until Hct decreases to a safe levels; evaluate patient for hypoxemia and sleep apnea; reinitiate
therapy at reduced rate
Obtain PSA, DRE, symptoms of BPH and sleep apnea 3 months after initiation of therapy, then yearly
PSA stable PSA rising DRE within normal limits DRE enlarging prostate No symptoms BPH Symptoms BPH No symptoms Sleep apnea Consider referral to urologist Consider referral to urologist
Post void residual by bladder scan and
consider referral to urologist
Continue present dose of Testosterone Symptoms Sleep apnea Consider sleep study .
Page12
PSA Due: _______________
3 mo __________/__________ Then yearly
Rectal Exam Due: ________
3 mo __________/__________ Then yearly
HCT Due/Results
3 mo __________/__________ Then yearlyTestosterone Level
Testosterone Protocol
Patient Name:________________________________
Chart No.: __________________________________
Date Initiated: ______________________________
Dose: ______________________________________
If dose changes, please document here:
_________________________ __________________________ _________________________ __________________________ _________________________ __________________________ _________________________ __________________________
Date Dose Site
Initials
Date Dose Site
Initials
Obtain Hct, PSA, DRE, symptoms of BPH and sleep apnea 3 months after
initiation of therapy, then yearly.
Page 14
THE EPWORTH SLEEPINESS SCALE
Name: ______________________________________ Today’s Date: _____________________
Age: __________________ Your Sex (M=Male, F=Female) ___________
How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just
tired? This refers to your usual way of life in recent times. Even if you have not done some of these
things recently, try to work out how they would have affected you. Use the following scale to
choose the most appropriate number for each situation.
Would
never
doze
=
0
Slight chance of dozing = 1
Moderate chance of dozing = 2
High chance of dozing = 3
Situation: (Circle most appropriate
number)
Chance
of
dozing
Sitting and reading
0 1 2 3
Watching TV
0 1 2 3
Sitting, inactive in public place such as a theater or a meeting
0 1 2 3
As a passenger in a car for an hour without a break
0 1 2 3
Lying down to rest in the afternoon when circumstances permit
0 1 2 3
Sitting and talking to someone
0 1 2 3
Sitting quietly after lunch without alcohol
0 1 2 3
In a car, while stopped for a few minutes in traffic
0 1 2 3
Page 15
BED PARTNER/OBSERVER QUESTIONNAIRE
Patient’s Name: _________________________________ Date completed: _________________
How likely are they to doze off or fall asleep in the following situations, in contrast to feeling just tired? This refers to their usual way of life in recent times. Even if they have not done some of these things recently, try to work out how they would have been affected. Use the following scale to choose the most appropriate number for each situation.
Would never doze = 0 Slight chance of dozing = 1 Moderate chance of dozing = 2 High chance of dozing = 3
Situation: (Circle most appropriate number) Chance of dozing
Sitting and reading 0 1 2 3
Watching TV 0 1 2 3 Sitting, inactive in public place such as a theater or a meeting 0 1 2 3 As a passenger in a car for an hour without a break 0 1 2 3 Lying down to rest in the afternoon when circumstances permit 0 1 2 3 Sitting and talking to someone 0 1 2 3 Sitting quietly after lunch without alcohol 0 1 2 3 In a car, while stopped for a few minutes in traffic 0 1 2 3
Total score (add all responses) _______________
Please circle any of the following statements that apply
1. I sleep in the same room as the patient. 2. I sleep in the same bed as the patient. 3. I sleep in a different room.
4. I have noticed no problem with the patient’s sleep.
5. I have noticed a problem for _____ weeks, months, years (circle one). 6. I am bothered by the patient’s snoring.
7. I am bothered by the patient’s not breathing for a short time. 8. I am bothered by the patient’s restless arm or leg movements. 9. I am bothered by the patient’s getting up at night.
10. I notice that the patient may frequently fall asleep inappropriately (watching TV, reading, etc.). 11. I cannot easily awaken the patient in the morning.
12. I have noticed a change in the patient’s personality in the past ____ weeks, months, years (circle one). How has it changed? ________________________________________________________________ Other comments: ___________________________________________________________________
Page 16
