Clinicians should discuss the cessation of testosterone therapy three to six months after commencement of treatment in patients who experience normalization of total testosterone levels but fail to achieve symptom or sign improvement. The goal of testosterone therapy is the normalization of total testosterone levels combined with improvement in symptoms or signs. Two studies145, 146 included in the evidence report that was developed in the support of this guideline suggest a link between radiation (in rectal cancer and prostate cancer patients) and low testosterone levels, however the studies are limited by heterogeneity in study populations, heterogeneity in radiation delivery, and the presence of confounders such as chemotherapy exposure.
In homeostasis, LH levels are typically low. Pituitary dysfunction may be a significant cause of testosterone deficiency. Testosterone deficiency is prevalent in men presenting for an infertility evaluation.159  The testes contain germ cells that produce spermatozoa and Leydig cells that produce testosterone; any pathology of the testes can result in infertility and testosterone deficiency, conditions that frequently co-exist.
For men with low blood testosterone levels and symptoms most likely caused by a low level, the benefits of hormone replacement therapy usually outweigh potential risks. Testosterone therapy may make sense for women who have low testosterone levels and symptoms that might be due to testosterone deficiency. However, many men with normal testosterone levels have similar symptoms, so a direct connection between testosterone levels and symptoms is not always clear. That's why medications that lower testosterone levels (for example, leuprolide) are common treatments for men with prostate cancer.
While the Panel is unable to quantify what percentage of men with ED and testosterone deficiency experience clinically meaningful improvements in erectile function (in contrast to statistically significant improvements) or the ability to achieve a functional erection, it is clear that some men will have improvement in erectile function with testosterone therapy. Study duration was also short, with only one study performed for 52 weeks.229 This may underestimate the true benefits of therapy as long-term prospective data suggest ongoing and slowly progressive improvements in erectile function occurring up to three years after treatment initiation.297 In trials, patients with low testosterone have demonstrated statistically significant improvements in erectile function, anemia, BMD, lean body mass, and depressive symptoms. The Testim Registry in the United States followed PSA changes in men without prostate cancer who were on testosterone therapy. In 2013, the AUA published the Early Detection of Prostate Cancer Guideline,222 which makes no specific statements about PSA screening in men with testosterone deficiency or in men on testosterone therapy. If the Hct exceeds 50%, clinicians should consider withholding testosterone therapy until the etiology of the high Hct is explained.187 While on testosterone therapy, a Hct ≥54% warrants intervention. Another multi-center study compared the effectiveness and risks of transdermal and IM testosterone in 66 men aged years old.
Testosterone deficient patients with low or low/normal LH levels can be considered candidates for SERM use as a treatment for testosterone deficiency, particularly those wishing to preserve their fertility.170 However, an LH level below which SERM response is optimized is not firmly established. Conversely, a recent study exposing patient testes to radiation (3 patients 17Gy and 4 patients 24Gy) demonstrated normal testosterone levels up to 3 years after radiation exposure.147 Specifically, the odds ratio for developing ED in men with total testosterone 6 used a single question to define ED and also showed an increase in ED risk as total testosterone levels decreased. In a small study of young men with acute respiratory infections, mean total testosterone levels declined by 10%, with some cohorts experiencing reductions of up to 30%.25 Where possible, clinicians should use LCMS to measure total testosterone levels to maximize accuracy and limit CV between tests in men undergoing testing, particularly in men with very low total testosterone levels. It was decided that a cut-off value was critical to define testosterone deficiency and that this cut-off be based on at least two total testosterone levels drawn in an early morning fashion at the same laboratory using the same assay.
As a result, there is some controversy about which men should be treated with supplemental testosterone. Estrogen therapy increases sex hormone binding globulin and, like aging men, this reduces the amount of free, active testosterone in the body. Testosterone may stimulate the prostate gland and prostate cancer to grow.
An overview of the assays available to aid in the diagnosis of testosterone deficiency is available in Table 4 (See button below). Given these inconsistences, prevalence of low testosterone has varied dramatically among studies, with statistics reporting %.5-8 A summary of findings from four large-scale contemporary prevalence studies can be found in Table 3 (See button below). Across the prevalence literature, the cut-off values used to define low testosterone vary widely, heterogeneity exists in the populations studied, the forms of testosterone used to measure testosterone (total and/or free) are not consistent, and the assays utilized to measure testosterone differ. A review by Millar et al.4 searched MEDLINE and Embase databases from January 1966 to July 2014 for studies that compared clinical indication of low testosterone along with a measurement of serum testosterone in men. The prevalence of testosterone deficiency in the American male population is difficult to quantify.
One RCT by Maggi et al. followed 715 testosterone deficient men for 12 weeks to evaluate the effects of a 2% transdermal testosterone agent on sex drive and energy. A discussion regarding the benefit of stopping testosterone therapy should include the possibility of a decline in PSA. PSA recurrence in men on testosterone therapy should be evaluated in the same fashion as untreated men. There are limited data in men on active surveillance who are candidates for testosterone therapy.

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