Decreased testosterone in the aging male: summary and conclusions. (2003)

Androgen replacement therapy has the potential to greatly improve the lives and general health of aging men who are no longer producing testosterone at levels sufficient to maintain the healthy vigor associated with youth. These therapies may improve body composition, improve sex drive and sexual function, alleviate depression, and improve mood.

Although there are significant benefits associated with androgen replacement therapy, a note of caution is warranted when initiating treatment. As Dr. Brawer correctly points out, there is no evidence linking androgen replacement therapy to carcinogenesis, although it does appear to promote the growth of already existing tumors. Thus, careful screening is required. Prior to treatment, patients should undergo digital rectal exams, and prostate specific antigen (PSA) levels should be measured. These tests should be performed again at 6 weeks, 3 months, 6 months, and annually for the duration of maintenance therapy.

Diagnosing andropause, because of the variability in presentation and etiologic factors, can be challenging; however, the advent of new diagnostic and outcome-assessment tools will make the process more exacting. As Dr. O’Leary explains, the currently available questionnaires have not been vigorously tested, but, he emphasizes, the processes for developing better tools already exist. That is, we need not reinvent the wheel; we need only reinvent already existing methodologies. Such tools are needed, and needed quickly, as the number of patients presenting to urologists’ offices with andropause is only likely to increase in the coming years.

The development of adequate tools will also help answer a fundamental question: Should every patient who presents with the signs and symptoms of andropause—changes in body composition, decreased libido, erectile dysfunction, depression—receive treatment? In his review, Dr. Matsumoto explains that the physiologic changes that occur over the course of a man’s life can be considered part of the natural aging process, not warranting any intervention. However, these changes can significantly impair the lives of both the patient and the patient’s partner for long periods of time. Androgen replacement therapy can safely alleviate the symptoms of andropause, such as erectile dysfunction and loss of muscle mass. It seems that, in the absence of any specific contraindications, most men presenting with the symptoms of andropause could benefit from therapy.

Nevertheless, there are numerous factors that must be considered when diagnosing andropause and wrestling with the decision of whether to treat the condition. As we learn from Dr. Heaton’s review, there are a number of clinical indicators that should raise the level of suspicion for andropause and the decision to treat should be based on these symptoms, rather than on serum testosterone levels. Interpreting the results of testosterone measurements is problematic, and may even be unnecessary. Normal testosterone levels range from 300–1200 ng/dL. Is a patient who presents with andropause symptoms, but a testosterone level of 350 ng/dL, technically normal, a candidate for intervention? It may be that testosterone levels are relative—in this patient 350 ng/dL may mark a precipitous drop from his testosterone levels from earlier in life. Or, 350 ng/dL may represent only a slight decrease from his youthful levels. Unfortunately, without an early-in-life baseline measure, it is impossible to discern. Such historically based comparisons may become necessary, as they provide more physiologically meaningful data than a single test conducted late in life.

Patient history is, in fact, a serious consideration when diagnosing, and considering treatment for, andropause. Whether to treat a patient following a radical prostatectomy is, for obvious reasons, a source of considerable debate. As Dr. McCullough’s case demonstrates, there are no clear answers to this dilemma. More studies and data are needed. Until more data are available, such patients should be considered for treatment on an individual basis.

In addition to deciding whether to treat, physicians must also choose from a variety of products. As Dr. Steidle reports, the newest androgen replacement formulation approved for the treatment of andropause is Testim™, a topical gel. In clinical trials, Testim produced approximately 30% higher serum testosterone levels than the other currently marketed gel formulation. Testim was found to have a safety profile similar to that of the other gel, and did not increase the short-term risk of prostate cancer.

As the elderly population continues to increase, so, too, will the incidence of andropause, and the number of patients presenting to physician offices in search of interventions that will prevent or reverse the physiologic deterioration of the body. Testosterone replacement therapy, can enhance the lives of patients by alleviating the symptoms of andropause and replacing lost testosterone. However, better diagnostic tools and outcome measures are still needed, as are more data regarding who can safely receive treatment so that these impressive, safe, and effective therapies can be fully utilized.