CONCORD INTERNAL MEDICINE TESTOSTERONE DEFICIENCY PROTOCOL

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1 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.

2 Testosterone Deficiency Protocol Table of Contents PAGE(S) INITIAL EVALUATION 1-5 TESTOSTERONE THERAPY 6-12 BPH SYMPTOMS INDEX QUESTIONNAIRE 13 EPWORTH SLEEPINESS SCALE 14 BED PARTNER/OBSERVER SLEEPINESS QUESTIONNAIRE 15 MEDICATIONS THAT ELEVATE PROLACTIN LEVELS 16

3 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 > 400ng/dl ng/dl <200ng/dl No further workup Repeat 8am Total Testosterone > 400ng/dl ng/dl < 200ng/dl No further workup Repeat total testosterone and Measure calculated 8am Free Testosterone Normal Free Testosterone No further workup Low Free Testosterone Measure LH and FSH Levels obtain DEXA scan if not already done Fasting iron, iron binding capacity and ferritin Normal Values for LH and FSH Elevated Values for LH and FSH TSAT < 45 TSAT > 45 Measure Prolactin Level, TSH and Free T4 Primary Hypogonadism No further evaluation Genotype for hemochromatosis See Page 2 Refer to Page 4 Determine Karyotype (Klinefelter s Syndrome)

4 Page 2 Free T4 Normal Low Age > 50 Age < 50 > 150 < 150 > 250 < 250 Refer to Page 3 Refer to Page 3 MRI of Pituitary MRI of Pituitary shows tumor MRI of Pituitary shows no tumor Refer to Endocrinologist Refer to Page 3

5 Page 3 Prolactin Level Normal Prolactin Level Elevated Prolactin Level Hypogonadotropic Hypogonadism Elevated TSH Normal TSH Treat for Hypothyroidism Once TSH normal Repeat Prolactin Level Patient on medication which could elevate Prolactin Level Refer to Page 16 Yes No Normal Prolactin Level Refer to Page 4 Elevated Prolactin Level If possible switch patient to medication that will not raise Prolactin level Order MRI of pituitary and refer to Endocrinologist Normal Prolactin Level Remeasure Prolactin level in 3 months Refer to Page 1 Remeasure 8am Level Elevated Prolactin Level

6 Page 4 Class III or IV CHF and/or History of Prostate or Breast Cancer No Yes Yes Symptoms of BPH Refer to Page 13 No treatment with Testosterone Perform DRE and PVR by Bladder Scan, obtain urinalysis and PSA then Refer to Urologist No Discuss with urologist if there is contraindications to treatment with testosterone Yes No treatment with testosterone Symptoms of Sleep Apnea Refer to Pages 14 & 15 for questionnaires Refer to Page 5 after questionnaires completed

7 Page 5 Symptoms of Sleep Apnea Refer to Pages 14 & 15 Yes No Sleep Study Sleep apnea present Sleep apnea not present Measure baseline PSA, Hct and Liver Profile Do DRE Treat sleep apnea 3 months Repeat 8 am Refer to Page 1 Abnormal PSA Normal PSA Hct > 50 Hct < 50 Abnormal Liver Panel Normal Liver Panel Abnormal DRE Normal DRE Refer to Urologist No Testosterone Evaluate before starting testosterone Refer to Urologist Contraindications to testosterone Yes No Add Testosterone Protocol in touchworks in patient s chart Refer to Page 12 Yes Contraindications to testosterone No Contraindications to testosterone Yes No No Testosterone No Testosterone No Testosterone Testosterone Treatment Refer to Page 6

8 Page 6 Testosterone Therapy 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 Total testosterone level > 700 level Increase Androgel or Testim to 7.5G * Androderm not available in 7.5mg at this time. If possible switch patient to Refer to Page 7 Continue present dose of Androgel, Androderm, or Testim Decrease Androgel, or Testim to 2.5G. Androderm to 2.5mg Refer to Page 11 Refer to Page 8

9 Page 7 Change Androgel or Testim to 7.5G Measure total serum testosterone level in 14 days Total testosterone level < 400 Total testosterone level Total testosterone level > 700 Increase Androgel or Testim to 10 G Continue present dose of Androgel/Testim Decrease Androgel or Testim to 5G Refer to Page 9 Refer to Page 11 Refer to Page 6

10 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 Total testosterone level > 700 level Increase Androgel or Testim to 5G, increase Andrederm to 5mg. Refer to Page 11 Stop Androgel, Androderm or Testim Refer to Page 6 Repeat 8 AM total serum testosterone in 3 months Refer to Page 1

11 Page 9 Increase Androgel or Testim to 10G Measure total serum testosterone level in 14 days Total testosterone level < 400 Total testosterone level Total testosterone level > 700 Stop Androgel or Testim and begin IM Testosterone per protocol-page 10 Refer to Page 11 Decrease Androgel or Testim to 7.5G Refer to Page 7

12 Page 10 IM Testosterone Protocol Testosterone Cypionate 200 mg IM q 2 weeks Obtain a total testosterone level 7days after the 4 th IM dose.* Testosterone level > 700 ng/dl Or < 400 ng/dl Testosterone level < 700 ng/dl Or > 400 ng/dl Adjust dose or frequency Refer to Page 11 *If for patient convenience, lab for testosterone could be pushed to after the 6 th 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.

13 Page 11 Continue Present dose Testosterone Obtain Hct 3 months after initiation of therapy then yearly Obtain PSA, DRE, symptoms of BPH and sleep apnea 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 PSA stable PSA rising DRE within normal limits DRE enlarging prostate No symptoms BPH Symptoms BPH No symptoms Sleep apnea Symptoms Sleep apnea Consider referral to urologist Consider referral to urologist Post void residual by bladder scan and consider referral to urologist Consider sleep study Continue present dose of Testosterone.

14 Page12 Testosterone Protocol Patient Name: Chart No.: Date Initiated: Dose: If dose changes, please document here: PSA Due: 3 mo / Then yearly Rectal Exam Due: 3 mo / Then yearly HCT Due/Results 3 mo / Then yearly Testosterone Level 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.

15 Page 13

16 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 Watching TV Sitting, inactive in public place such as a theater or a meeting As a passenger in a car for an hour without a break Lying down to rest in the afternoon when circumstances permit Sitting and talking to someone Sitting quietly after lunch without alcohol In a car, while stopped for a few minutes in traffic Total score (add all responses)

17 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 Watching TV Sitting, inactive in public place such as a theater or a meeting As a passenger in a car for an hour without a break Lying down to rest in the afternoon when circumstances permit Sitting and talking to someone Sitting quietly after lunch without alcohol In a car, while stopped for a few minutes in traffic 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:

18 Page 16 Medications that Elevate Prolactin Levels Phenothiazines Butyrophenones Monoamine oxidase inhibitors Tricyclic antidepressants Methyldopa Metoclopramide Amoxapine Verapamil Cocaine Fluoxetine c:\forms\testosterone1 Douglas G. Kelling, Jr., MD

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