Testosterone Replacement Therapy. Craig Ensign, MPAS, PA-C University of Utah School of Medicine Urology Division
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1 Testosterone Replacement Therapy Craig Ensign, MPAS, PA-C University of Utah School of Medicine Urology Division
2 Lecture Outline 1. Anatomy and physiology 2. Definition and etiology 3. Signs and symptoms 4. Benefits, options, and risks of treatment 5. Prostate cancer and T replacement No disclosures to report
3 Testicle Anatomy 3
4 Hypothalamus GnRH Anterior Pituitary Inhibin FSH LH Testosterone Sertoli Cells Leydig Cells Spermatozoa Testosterone Testis 4
5 Physiological Effects of Testosterone Develops and maintains secondary sex characteristics Stimulates spermatogenesis Stimulates and maintains sexual (including erectile) function Increases lean body mass (muscle), decrease adipose tissue accumulation (fat) Maintains bone mass Promotes sebum production and body hair growth Stimulates erythropoiesis (red blood cell formation) 5
6 Hypogonadism Defined Many definitions, this is one: A clinical syndrome that results from failure of the testis to produce physiological levels of testosterone and the normal number of spermatozoa caused by disruption of one or more levels of the hypothalamic-pituitary-gonadal axis 6
7 Prevalence of Hypogonadism Difficult to measure/several longitudinal and cross sectional studies have been done European Male Aging Study (EMAS) 5.6% of men between 70 and 79 years of age Boston Area Community Health Survey (BACHS) 18.4% of men at 70 years of age Baltimore Longitudinal Study of Aging (BLSA) 19% of men at 60 years of age Hypogonadism in Males (HIM) 39% of men 45 years or older Variables: definitions, symptoms, populations studied, comorbidities
8 Consistent Hypogonadism Findings Prevalence of Hypogonadism increases with age starting at age 40: Based on symptoms And lab values: total and free testosterone levels Hypogonadism is more likely in men with: Metabolic syndrome Type II diabetes Cardiovascular disease Some studies ascribe hypogonadism to comorbid conditions
9 Why be Concerned? 2010 number of men > 65: 40 million (13%) 2025 projection of men > 65: 65 million (17.9%) Estimates show about 5-35% of hypogonadal males are actually treated Based on percentages, the total number of hypogonadal men will increase significantly Based on rising total numbers, increasing percentages, and increasing awareness of the condition, many men will potentially seek treatment 9
10 Signs & Symptoms Yes No Check Total T Low T <250 ng/dl Low normal ng/dl Free T, LH, FSH Evaluate for reversible causes No Low free T Normal total T: >400 ng/dl Unlikely to by hypogonadism Primary Low total T, high LH & FSH May repeat Secondary Low total T, low/normal LH, FSH Follow-up Mixed Primary and secondary Low free T, high LH,FSH Primary Hypo W/up Low free T Normal LH, FSH Secondary Hypo work-up Primary Karyotype To rule out Klinefelter s Primary Prolactin Pituitary labs MRI Tumor W/up Infiltrative Process Iron, TIBC Age related androgen deficiency LOH Alcohol steroids, HIV, other infections, systemic 10
11 Non-specific signs and symptoms Loss of energy, motivation, initiative, self-confidence Feeling sad or blue, depressed mood, dysthymia Poor concentration and memory Sleep disturbance, increased sleepiness Mild anemia (normochromic, normocytic) Reduced muscle bulk and strength Increased body fat, body mass index Sexual dysfunction ED, poor libido Diseases with high prevalence of hypogonadism Long-term Rx with medications that affect testosterone production or metabolism, such as glucocorticoids and opioids HIV-associated weight loss End-stage renal disease and maintenance hemodialysis Infertility Osteoporosis or low trauma fracture, especially in a young man Pituitary mass, radiation of the pituitary region 11
12 The Chicken or the Egg? Question: Is low T a cause or an effect? Most experts believe that it is a medically significant condition resulting in significant detriment to the quality of life and adversely affecting the function of multiple organ systems; while others suggest that it is a chemical marker of generalized illness. 12
13 Hypogonadism Odds Ratios Condition Odds Ratio Obesity 2.38 Diabetes 2.09 Hypertension 1.84 Hyperlipidemia 1.47 Osteoporosis 1.41 Asthma/COPD
14 Signs & Symptoms Yes No Check total T Low T <250 ng/dl Low normal ng/dl Free T, LH, FSH Total testosterone >350 ng/dl Low normal ng/dl Free testosterone Free testosterone 1-2% Albumin bound testosterone 40-50% 50-60% is bound strongly to SHBG, and is not bioavailable Dihydrotestosterone (DHT) is active form of testosterone Testosterone converted to DHT by 5 α -reductase mainly in prostate Testosterone and DHT bind to androgen receptors to exert their biologic effect Luteinizing hormone ( IU/L) Follicle stimulating hormone ( IU/L)
15 Total Testosterone Levels Normal total T in adult men between ng/dl Early morning total T below 250 ng/dl likely hypogonadal Repeat measurement is required to make diagnosis Total T levels between ng/dl considered the Grey Zone, repeat to establish true levels Total T is only part of the laboratory work-up Free T, SHBG, LH, FSH
16 Time of Day is Significant Circadian rhythm affects GnRH, levels change throughout the day Testosterone levels are highest before 10 AM Levels are lowest by 10 PM Variability decreases in older men because of changes to circadian rhythm Levels should be measured in the morning when levels are highest Repeat measurements are necessary to make the diagnosis
17 Check total T Low T <250 ng/dl Low normal ng/dl Free T, LH, FSH Illnesses Stress from any illness Stress from surgery Inflammatory diseases Drug toxicity Opioids steroids Nutritional deficiency Obesity Vitamin deficiencies 17
18 Low free T Low free T, high LH,FSH Primary Hypo W/up Low free T Normal LH, FSH Secondary Hypo work-up Primary Karyotype To rule out Klinefelter s Primary Hypogonadism (in aging men) Testicular failure, Leydig and Sertoli cells not functioning Low testosterone levels High LH and FSH levels Also called Hypergonadotropic Hypogonadism Causes: trauma, tumor, infection, genetic disorders, chemotherapy, radiation, alcohol abuse, aging process 18
19 Low free T Low free T, high LH,FSH Primary Hypo W/up Low free T Normal LH, FSH Secondary Hypo work-up Primary Karyotype To rule out Klinefelter s Secondary Hypogonadism Insufficient stimulation of Leydig and Sertoli cells Low FSH, LH, and testosterone Also called Hypogonadotropic Hypogonadism Causes: hypothalamic/pituitary disorders, hyperprolactinemia, Kallmann syndrome, medications, illnesses, aging process 19
20 Low free T Low free T, high LH,FSH Primary Hypo W/up Low free T Normal LH, FSH Secondary Hypo work-up Primary Karyotype To rule out Klinefelter s Klinefelter s Syndrome (Congenital) Karyotypes describe the number of chromosomes, and what they look like under a light microscopy Symptoms resulting from additional X genetic material in males Also known as 47,XXY or XXY 20
21 Congenital Causes Unlikely in Aging Men Congenital causes appear at younger ages Acquired or idiopathic causes more likely in aging men Evaluate possible secondary causes of hypogonadism: Hypothalamic/pituitary disease Hyperprolactinemia Depression Alcoholism Diabetes mellitus Infiltrative diseases/hemochromatosis/medications
22 Primary Low total T, high LH & FSH Secondary Low total T, low/normal LH, FSH Mixed Primary and secondary Primary Prolactin Pituitary labs MRI Tumor W/up Infiltrative Process Iron, TIBC Age related androgen deficiency LOH Alcohol steroids, HIV, other infections, systemic 22
23 Primary Low total T, high LH & FSH Secondary Low total T, low/normal LH, FSH Mixed Primary and secondary Primary Prolactin Pituitary labs MRI Tumor W/up Infiltrative Process Iron, TIBC Age related androgen deficiency LOH Alcohol steroids, HIV, other infections, systemic 23
24 Primary Low total T, high LH & FSH Secondary Low total T, low/normal LH, FSH Mixed Primary and secondary Primary Prolactin Pituitary labs MRI Tumor W/up Infiltrative Process Iron, TIBC Age related androgen deficiency LOH Alcohol steroids, HIV, other infections, systemic 24
25 Primary Low total T, high LH & FSH Secondary Low total T, low/normal LH, FSH Mixed Primary and secondary Primary Prolactin Pituitary labs MRI Tumor W/up Infiltrative Process Iron, TIBC Age related androgen deficiency LOH Alcohol steroids, HIV, other infections, systemic 25 Names for Low T in Men Hypogonadism Late-Onset Hypogonadism (LOH) Androgen Deficiency in the Aging Male (ADAM) Partial Androgen Deficiency in the Aging Male (padam) Testosterone Deficiency Syndrome (TDS) Andropause
26 Hypogonadism in Older Men Focus now on secondary and mixed hypogonadism Decrease in Leydig cell function decreased total and free T Decreased pituitary/hypothalamic function decreased LH Increased SHBG (20-60 nmol/l) Changes in testosterone receptor sensitivity
27 Decision to Treat A definitive diagnosis of hypogonadism must be established to treat Borderline lab values without symptoms are not an indication to treat Lab findings must be combined with signs, symptoms and issues with the patient s quality of life Without symptoms and abnormal lab values, don t treat
28 Signs & Symptoms include: Libido Vitality Muscle mass Adiposity Depressed mood Osteopenia Osteoporosis Quality of Life Indicators
29 Possible Benefits of Testosterone Replacement Improved muscle mass and strength Increased bone mineral density Decreased adiposity Improved lipid and glucose control Improved cardiovascular health Better sexual function Improved mood and cognitive function
30 Possible Contraindications for Treatment Men who still desire fertility Severe lower urinary tract obstruction Untreated sleep apnea Prostate cancer* Breast cancer Elevated hematocrit (>50%) Poorly controlled heart failure 30
31 Goals of Treatment Raise serum testosterone level to ng/dl Resolution or reduction of symptoms Reduce disease and disability Improve quality of life Add vitality to the patient s aging years
32 Testosterone Treatment Options Intramuscular injections Transdermal Gels Patches Implantable testosterone pellets Oral preparations (not available in the US)
33 IM Injections Starting dosage 200 mg every two weeks Peak levels achieved in 2-3 days Levels checked and adjusted based on T midway between injections Advantages Quick onset Dosage and time can be adjusted Disadvantages Peak and trough effect Some men don t like needles 33
34 Management and Follow-up Initial work-up including history, PE and labs Follow-up within three months: Asses symptom improvement Check testosterone levels Check for complications: Liver function Hemoglobin/hematocrit PSA Then annually
35
36 Possible Risks of Testosterone Replacement Cardiovascular disease Literature looks protective Sleep apnea Polycythemia DVT, Stroke, PE Prostate health Next slide Decreased fertility potential Contraindicated in men who desire fertility Dermatologic changes (oily skin and acne)
37 Prostate Health and Testosterone BPH Castration relieves symptoms caused by BPH BPH symptoms normalize after six months of testosterone replacement Prostate Cancer Concern originated with Huggins & Hodges in 1941 Androgen depletion therapy (Lupron) leads to dramatic decrease in PSA levels in men with prostate cancer Naturally occurring variation in serum T appears to have little influence on PSA Bottom line: no significant evidence of relationship between testosterone replacement and prostate cancer
38 Reference Articles Hypogonadism in the Aging Male Diagnosis, Potential Benefits, and Risks of Testosterone Replacement Therapy Diagnosis and treatment of late-onset hypogonadism: Systematic review and meta-analysis of TRT outcomes A practical guide to male hypogonadism in the primary care setting Testosterone Therapy in Men With Prostate Cancer: Scientific and Ethical Considerations 38
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