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Treat Endocrinol 2005; 4 (5): 293-309 REVIEW ARTICLE 1175-6349/05/0005-0293/$34.95/0

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Treat Endocrinol 2005; 4 (5): 293-309 REVIEW ARTICLE 1175-6349/05/0005-0293/$34.95/0 Treat Endocrinol 2005; 4 (5): 293-309 REVIEW ARTICLE 1175-6349/05/0005-0293/$34.95/0 2005 Adis Data Information BV. All rights reserved. Male Hypogonadism An Update on Diagnosis and Treatment Emily Darby and Bradley D. Anawalt Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle, Washington, USA Contents Abstract ...............................................................................................................293 1. Hypothalamic-Pituitary-Testicular Axis .................................................................................294 2. Etiologies ...........................................................................................................294 3. Diagnosis ...........................................................................................................295 3.1 History and Physical Examination .................................................................................295 3.2 Screening Questionnaires ........................................................................................295 3.3 Laboratory Testing ..............................................................................................295 3.4 Further Work-Up ................................................................................................296 4. Physiologic Effects of Androgen Replacement Therapy .................................................................296 4.1 Physiologic Benefits versus Risks of Androgen Replacement Therapy .................................................296 4.2 Sexual Function .................................................................................................297 4.3 Lean Body Mass, Strength, and Fat Mass ..........................................................................297 4.4 Bone Density and Fractures ......................................................................................297 4.5 Mood ..........................................................................................................298 4.6 Bladder Outlet Obstruction ......................................................................................298 4.7 Prostate Cancer ................................................................................................298 4.7.1 Testosterone and Prostate Cancer ..........................................................................298 4.7.2 Dihydrotestosterone (Androstanolone) and Prostate Cancer ..................................................299 4.8 Cardiovascular Disease .........................................................................................299 5. Treatment Options ..................................................................................................299 5.1 Oral Androgens .................................................................................................299 5.1.1 Alkylated Oral Testosterones ...............................................................................299 5.1.2 Testosterone Undecanoate ................................................................................299 5.1.3 Buccal Testosterone .......................................................................................301 5.1.4 Other Oral Preparations ...................................................................................301 5.2 Injectable Androgens ...........................................................................................301 5.2.1 Testosterone Esters ........................................................................................301 5.2.2 Testosterone Undecanoate Injections .......................................................................301 5.2.3 Testosterone Buciclate (Bucyclate) .........................................................................302 5.2.4 Microencapsulated Testosterone ...........................................................................302 5.3 Implantable Androgens .........................................................................................302 5.4 Transdermal Testosterone ........................................................................................302 5.4.1 Scrotal Testosterone Patch .................................................................................302 5.4.2 Non-Scrotal Testosterone Patch ............................................................................302 5.4.3 Testosterone Gel ..........................................................................................303 5.5 Dihydrotestosterone Gel .........................................................................................303 5.6 Selective Androgen Receptor Modulators/7-α-Methyl-19 Nortestosterone ............................................304 5.7 Treatment to Achieve Fertility ....................................................................................304 6. Monitoring Recommendations .......................................................................................304 7. Conclusions ........................................................................................................305 Abstract Male hypogonadism is one of the most common endocrinologic syndromes. The diagnosis is based on clinical signs and symptoms plus laboratory confirmation via the measurement of low morning testosterone levels on 294 Darby & Anawalt two different occasions. Serum luteinizing hormone and follicle-stimulating hormone levels distinguish between primary (hypergonadotropic) and secondary (hypogonadotropic) hypogonadism. Hypogonadism associated with aging (andropause) may present a mixed picture, with low testosterone levels and low to low-normal gonado- tropin levels. Androgen replacement therapy in hypogonadal men has many potential benefits: improved sexual function, an enhanced sense of well-being, increased lean body mass, decreased body fat, and increased bone density. However, it also carries potential risks, including the possibility of stimulating the growth of an occult prostate cancer. The benefits of androgen therapy outweigh the risks in men with classic hypogonadism. However, for men with mild hypogonadism or andropause, the balance between benefits and risks is not always clear. Unfortunately, studies to date have included too small a number of patients and have been too short in duration to provide meaningful data on the long-term risks versus the benefits of androgen replacement therapy in these populations. Several products are currently marketed for the treatment of male hypogonadism. Weekly-to-biweekly injections of testosterone cypionate (cipionate) or testosterone enanthate (enantate) are widely used, as they are economical and generally well tolerated. However, once-daily transdermal therapies have become increasingly popular and now include both patch and gel systems. Intramuscular injection of testosterone undecanoate is an attractive new therapy that can be administered quarterly. To confirm an adequate replacement dosage, assessment of clinical responses and measurement of serum testosterone levels generally suffice. For selected men, serial measurement of bone mineral density during androgen therapy might be helpful to confirm end-organ effects. For men aged >50 years, we advocate measurement of hematocrit for detection of polycythemia and a digital rectal examination with a serum prostate-specific antigen level measurement for prostate cancer screening during the first few months of androgen therapy. Subsequently, a hematocrit should be obtained yearly or after changes in therapy, and annual prostate cancer screening can be offered to the patient after a discussion of its risks and benefits. Many physicians remain under-educated about hypogonadism gonadotropin levels (hypergonadotropic hypogonadism). Secon- despite the fact that it is one of the most common endocrinologic dary and tertiary hypogonadism, caused by pituitary under-secre- disorders in men. Klinefelter syndrome alone occurs in 1 in 500 tion of LH and FSH and hypothalamic under-secretion of GnRH, [1] men. In addition, the prevalence of men with low testosterone respectively, are usually grouped together and termed secondary levels increases dramatically with age. While 12% of men aged hypogonadism or hypogonadotropic hypogonadism. Aging-relat- <50 years have serum total testosterone levels in the hypogonadal ed androgen deficiency is frequently due to a combination of range, almost 50% of men in their 80s have low serum total testicular and hypothalamic dysfunction. testosterone levels.[2] The estimated prevalence of clinical hypogo- nadism (low serum testosterone levels plus symptoms) is lower but still significant: 4.1% for men aged 40–49 years and 9.4% for 2. Etiologies men aged 60–70 years, respectively.[3] The purpose of this review is to discuss key issues in the diagnosis, sequelae, and treatment of The causes of male hypogonadism are diverse and include this common condition, with particular emphasis on the variety of genetic disorders, pituitary tumors, endocrinopathies such as therapies currently available for androgen replacement. hyperprolactinemia and Cushing syndrome, systemic diseases, 1. Hypothalamic-Pituitary-Testicular Axis Table I. Classification of hypogonadism Gonadotropin-releasing hormone (GnRH) is secreted in a pul- Classification Location of Testosterone FSH and LH satile fashion from the hypothalamus and stimulates the release of pathology luteinizing hormone (LH) and follicle-stimulating hormone (FSH) Primary Testes Low to low- High from the pituitary
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