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Testosterone replacement options: Guidelines Take New Look at Management of Hypogonadism in Men
By eInternal Medicine News: Michele G. Sullivan
Feb 16, 2003, 11:39am

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Updated guidelines on diagnosis and treatment of hypogonadism in men reflect advances in treatment and more robust data about the short-term benefits of testosterone replacement therapy.

The guidelines, issued by the American Association of Clinical Endocrinologists (AACE), also urge additional research into the long-term use of the therapy and its possible effects on the risks of cancer and cardiovascular disease.

�Concern about long-term safety and efficacy remains an issue,� said Dr. Steven M. Petak, chair of the guidelines revision committee.

�Perhaps these new guidelines will stimulate some additional research into these issues,� said Dr. Petak, an endocrinologist at the Texas Institute for Reproductive Medicine and Endocrinology, Houston.

The National Institute on Aging has begun work on a 1-year study to evaluate the feasibility of conducting clinical trials of testosterone replacement therapy in older men. A task force will report on the known benefits and risks of the therapy, its potential public health impact, and the ethical issues involved in conducting such a clinical trial. The report is expected by November, said Dr. Stanley Slater, deputy director of the institute's geriatrics and clinical gerontology program.

The new AACE guidelines include a detailed discussion of clinical and laboratory findings, plus a diagnosis and treatment algorithm based on testicular size, hormone levels, and semen analysis. The revision is the first since the guidelines were initially issued in 1996.

It's important to focus attention on the recognition and treatment of the disorder because many men are reluctant to discuss the symptoms of hypogonadism with their physicians. Symptoms usually include decreased libido, impotence, decreased muscle mass, fatigue, and decreased bone density.

�Many men don't seek out medical attention for health problems in the early stage,� Dr. Petak said. �And they don't feel comfortable talking about the major symptom, loss of libido.�

Even if patients do mention decreased sexual urge, physicians might be more likely to prescribe Viagra than to perform a full evaluation. �Lots of physicians don't delve into the matter too deeply, either for lack of time or because of the level of discomfort,� he said. A thorough evaluation is important because hypogonadism may arise from problems with the testes, pituitary, or hypothalamus, or by a genetic disorder.

The AACE guidelines are aimed at three target populations:

Men with primary testicular failure who require hormone replacement.

Men with gonadotropin deficiency or dysfunction who may have received testosterone replacement therapy or treatment for infertility.

Aging men whose could benefit from testosterone therapy.

Diagnostic criteria are based on physical assessment, hormone levels, dynamic testing (GnRH and clomiphene stimulation tests), and semen analysis. Additional diagnostic studies include bone densitometry, pituitary imaging, genetic studies, testicular biopsy, and scrotal exploration.

No studies have clearly indicated that a particular testosterone level is associated with pituitary tumors. But a total testosterone level of less than 150 ng/dL should trigger a pituitary imaging study, even in the absence of other symptoms, the guidelines state.

The treatment goal is the same in each target population�to restore sexual function (including fertility, if desired and possible), libido, behavior, and physical well-being. In addition to decreased sex drive and sexual activity, men with low testosterone levels may exhibit anger, depression, fatigue, and confusion, as well as physical effects such as decreased muscle mass and bone density and associated osteoporosis.

Based on the results of recent studies, the new guidelines state that testosterone replacement often alleviates associated psychological conditions, increases virilization, and optimizes bone density. Recent studies also indicate that the therapy may normalize growth hormone levels in elderly men. Therapy also may decrease cardiac mortality in this population, but the guidelines make no specific recommendations in this area because the link between cardiovascular disease and low testosterone is not fully understood.

The AACE guidelines evaluate testosterone replacement methods (injection, patch, gel, and oral agents) and stress that patients on testosterone replacement need to be carefully monitored for possible adverse effects. Careful monitoring of prostate-specific antigen is particularly important, and men with known prostate cancer should never use testosterone replacement therapy.

The full guidelines are available online at

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