Diagnosis, Treatment and Monitoring of Male Late Onset Hypogonadism

From: http://www.smsna.org/about/dtmmloh.asp

Testosterone supplementation is indicated for men who have signs and symptoms of hypogonadism accompanied by subnormal serum testosterone measurements. Testosterone supplementation can provide important health benefits to these hypogonadal men. Testosterone supplementation should be administered only under competent and careful medical surveillance in order to identify early signs of possible adverse effects. Although the benefits and risks of long-term testosterone supplementation have not yet been definitively established, the weight of current evidence does not suggest an increased risk of heart disease or prostate cancer with long-term use of testosterone. Testosterone is not medically indicated in men who do not have hypogonadism.

1. Definition.
Hypogonadism is a clinical and biochemical syndrome associated with a deficiency in serum testosterone. Manifestations include diminished sexual interest and performance, depression, lack of energy and vitality, anemia, decreased bone density and muscle mass. When this symptom complex occurs in the adult male, it is known as late onset hypogonadism, androgen deficiency in the aging male (ADAM) or andropause.

2. Diagnosis
The diagnosis of hypogonadism is made by correlating the clinical signs and symptoms with blood tests documenting low levels of serum testosterone.

3. Evaluation
A. Symptoms. The clinical picture includes diminished sexual desire and erectile quality, depressed mood, irritability, tiredness and fatigue. These manifestations need not all be present to identify the syndrome and the severity of one or more does not necessarily match the severity of the others.
B. Physical examination. The physical examination is frequently unremarkable. Small or soft testicles may be present. Gynecomastia, truncal obesity, loss of muscle mass and manifestations of osteoporosis may also be associated with hypogonadism.C. Blood tests. The levels of serum testosterone, normally, are highest in the morning and may decline significantly throughout the day. Several blood assays to measure serum testosterone are available. Total testosterone is most commonly used but requires awareness that its values may not reflect the amount of metabolically active testosterone fractions. For this reason, measurement of bioavailable or free testosterone may more closely correlate with clinical symptoms.D. Other blood tests. Follicle stimulating hormone (FSH), luteinizing hormone (LH) and prolactin are frequently assayed to assist in determining the cause of hypogonadism (primary vs secondary).

4. Treatment
Presently, injectable, oral and transdermal preparations of testosterone are available in North America. With the exception of testosterone undecanoate (currently unavailable in the United States), oral preparations carry a significant risk of liver toxicity. Injectable, transdermal and the oral undecanoate are all acceptable treatment options.

5. Benefits and risks
A. Benefits. Benefits of testosterone supplementation include improvement in any or all of the following: sense of well being, sexual function (sexual interest and erection), energy, mood, cognition and body composition (muscle strength, bone mineral density, fat distribution and correction of anemia).B. Adverse effects. Adverse effects of testosterone supplementation include erythrocytosis, increased prostate volume, gynecomastia, edema, testicular atrophy and acne. C. Risks. Risks include exacerbation of a pre-existing (sub-clinical) cancer of the prostate. Worsening of sleep apnea is also a potential risk of testosterone administration.

6. Monitoring and follow-up
Careful, regular monitoring is recommended at 3-6 month intervals for the first year and at 6-12 month intervals thereafter. Physician’s evaluation should include an assessment of the clinical response, a digital rectal examination, blood tests for testosterone, hemoglobin, hematocrit, and prostate specific antigen (PSA). Lipid profile and liver function tests may also be considered.
February 11, 2003(Submitted by the Androgen Supplement SubCommittee, a subcommittee of the SMS Health Policy Committee)Alvaro Morales, M.D., Kingston, ONTChairman Culley Carson, M.D., Chapel Hill, NCWayne Hellstrom, M.D., New Orleans, LALarry Lipshultz, M.D., Houston, TXAbe Morgentaler, M.D., Boston, MA