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Male hypogonadism is defined as the failure of the testes to produce androgen, sperm, or both.
Testosterone production declines with advancing age; 20% of men older than 60 years and 30% to 40% of men older than 80 years have serum testosterone levels that would be subnormal in their younger adult male counterparts. Male factor infertility is probably responsible for one third of the 10% to 15% of couples who are unable to conceive within 1 year of unprotected intercourse.
The physiologic regulation of the hypothalamic-pituitary-gonadal axis is shown in Figure 1. Male hypogonadism is caused by a primary (hypergonadotropic) testicular disorder or is secondary (hypo- or normogonadotropic) to hypothalamic-pituitary dysfunction, as illustrated in Figure 3.
Persistent failure of the testes to descend may be an early manifestation of testicular dysfunction. Delayed, arrested, or absent testicular growth and secondary sexual characteristic development are hallmarks of pubertal disorders. The first manifestation of hypogonadism may be a consequence of a large space-occupying intrasellar or parasellar lesion manifested by headaches, bitemporal hemianopia, or extraocular muscle palsy. Because of the well-known diurnal rhythm of serum testosterone, which appears to be lost with age (>60 years), with values 30% or so higher near 8 am versus the later day trough, a testosterone value should be determined first thing in the morning. If gonadotropin levels are not elevated, despite clearly subnormal testosterone values, anterior pituitary (thyroid-adrenal) function should be determined by measuring free thyroxine and thyroid-stimulating hormone levels, as well as an early morning cortisol level. Androgen replacement therapy is relatively straightforward; see Box 4 for testosterone preparations currently available in the United States.
In genuinely hypogonadal men, testosterone administration can be expected to result in improvements in a variety of clinical areas (Box 6). Concerns regarding the use of testosterone have been noted in Box 5 and by Rhoden and Morgentaler.2 There is no evidence that the incidence of prostate cancer is increased by testosterone replacement. The aging man represents a special case and has been the subject of a review.4 There is a well-known decline in testosterone production with aging in otherwise healthy men.
The ultimate issue as to whether these changes are normal and physiologic or should be considered pathologic, thus demanding therapy, remains unresolved. The American Association of Clinical Endocrinologists has published 2002 updated guidelines for the evaluation and treatment of hypogonadism in adult male patients.11 This review, geared particularly for endocrinologists, expands on some of the areas reviewed in this chapter and provides a more detailed look into aspects of male infertility.
The Endocrine Society has published clinical practice guidelines12 for testosterone replacement therapy. Recommend diagnosis of androgen deficiency only in men with consistent symptoms and signs and with unequivocally low serum testosterone levels. Rhoden EL, Morgentaler A: Risks of testosterone-replacement therapy and recommendations for monitoring. Bremner WJ, Vitiello MV, Prinz PN: Loss of circadian rhythmicity in blood testosterone levels with aging in normal men. This apparent physiologic decline in circulating androgen levels is compounded in frequency by permanent disorders of the hypothalamic-pituitary-gonadal axis (see later).


Most of these male-associated cases result from diminished, absent, or faulty spermatogenesis. In addition, a normally formed but hypotrophic penis may provide a clue to an abnormality of the hypothalamic-pituitary-gonadal axis. Skeletal proportions may be abnormal (eunuchoid) with more than a 5-cm difference between span and height and between pubis-floor and pubis-vertex dimensions. Perhaps the minor contribution of adrenal androgens (or androgenic precursors) may substitute for testicular deficiency once the target tissues have been fully developed. Typically, the depot esters are administered by the deep intramuscular route once every 2 weeks at a dose of 200 mg in adults.
Values are stable within a few days or weeks of the skin patch, gel, or newer buccal preparation. If the patient is truly hypogonadal to begin with, expect a significant rise at the 3-month assessment. It should be noted that no long- term studies in large numbers of patients (neither young or old) have been performed, so potential risks and benefits need to be individualized.
Least predictable are the effects on sexual function, cognitive function, and muscle strength. The underlying concern is that it might alter the course of an occult malignancy estimated to be present in more than 50% of men older than 50 years. This decline in mean values can be seen in free testosterone levels, beginning in the mid-40s (some clinicians suggest even earlier), as a consequence of increasing SHBG levels, mechanism unknown. Indeed, it is a situation analogous to the ongoing dilemma of hormone replacement therapy for postmenopausal women, although in this group the hormonal deficiency state is usually more abrupt and symptomatic.
In addition to monitoring testosterone levels periodically, prostate screening by digital rectal examination and prostate specific antigen determinations at periodic intervals when the patient is on therapy should be carried out. These include the transient deficiency states associated with acute stressful illnesses, such as surgery and myocardial infarction, and the more chronic deficiency states associated with wasting illnesses, such as cancer and acquired immunodeficiency syndrome. In addition to abnormal sperm production, other conditions, including obstructive ductal disease, epididymal hostility, immunologic disorders, and erectile or ejaculatory dysfunction should be considered. Some clinicians believe that the bioavailable fraction, the fraction present in the supernatant after ammonium sulfate precipitation, representing testosterone loosely bound predominantly to serum albumin, is more meaningful.
Unexplained osteoporosis or mild anemia sometimes is the clue to an underlying hypogonadal state.
An exception to this recommendation is the condition of morbid obesity, in which both total and free testosterone levels are typically low and gonadotropin values not elevated. Greater increments tend to occur more frequently with the intramuscular than with the transdermal preparations. On the other hand, no one would recommend prophylactic castration to prevent prostate cancer so that, in my view, testosterone replacement in the hypogonadal man should not be avoided. The IMCTA has not recommended a large-scale study to determine whether the risk for prostate cancer would be increased, because the costs of such a study were deemed to be too prohibitive.


Measurement of free testosterone levels or bioavailable testosterone levels (performed adequately in select commercial laboratories) may provide additional information, in addition to serum follicle-stimulating hormone, luteinizing hormone, and prolactin levels. Finally, because combined female-male infertility is common, and fertility as well as psychological well-being are ultimate goals, both partners must be assessed from the outset.
Hepatic SHBG production rises with aging and thyroid hormone excess and declines in hyperinsulinemic states (obesity and type 2 diabetes), so that free testosterone values may not always be concordant with total testosterone values. Certainly, prolactin excess, testosterone deficiency, or both in men may result in impaired libido and erectile dysfunction.
Although comparable testosterone levels are reached by the patch and the gels, skin reactions at the application site are much more common with the patch.
These criteria continue to be revised by our urology colleagues, tending to become more stringent with time.
Although there are genuine concerns about worsening of benign prostatic hyperplasia, this may apply only to severe cases with large prostate volumes.
The diurnal rhythm, seen in younger men, is lost beyond 60 years.5 Although testicular volume also declines in this age group, spermatogenesis may be well maintained into the 80s or even beyond. The biologic effects of testosterone may be mediated directly by testosterone or by its metabolites 5α-dihydrotestosterone or estradiol (Fig. The yield of finding hyperprolactinemia or testosterone deficiency, or both, in patients presenting with these symptoms is generally considered to be low, usually less than 5%. The subject of androgen deficiency and the aging man is dealt with in greater detail later in this chapter. Because the acute effect of stressful illness may result in a transient lowering of testosterone levels, a confirmatory early morning specimen should be obtained. The major disadvantage with the parenteral route is that testosterone levels exhibit a saw-toothed pattern, with high-normal or supranormal levels on days 2 to 4 and low-normal or borderline low trough values before the next injection. Gonadotropin levels tend to rise after 70 years, indicating that the testosterone deficiency is usually primary.6 Figure 4 schematically presents these hormonal changes with age.
Alkylated oral androgens should be viewed as potentially hepatotoxic and should not be used. For example, free testosterone levels may be lower than expected from the total testosterone level as a result of aging and higher than expected in insulin-resistant individuals, such as in obesity. Useful criteria for selecting preparations for individual patients are summarized in Table 1. In addition, serum follicle-stimulating hormone (FSH), luteinizing hormone (LH), and prolactin levels should be determined to help delineate the cause of the testosterone-deficient state.



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