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Testosterone Replacement Therapy in Canada

Testosterone replacement therapy is a licensed treatment for conditions causing decreased production of testosterone (primary or secondary hypogonadism) and is currently on a limited use (LU) list on the Ontario Provincial Drug Program (OPDP). The actual method of treatment, called TRT (testosterone replacement therapy), involves a controlled injection of testosterone to try and replace a persons natural production of testosterone, which can become deranged for various reasons. Testosterone replacement therapy is designed to boost the levels of testosterone among men who are lacking this hormone. The safety of testosterone replacement therapy has been called into question in recent years, with multiple studies suggesting that a sudden increase in testosterone levels can raise the risk of heart attack, stroke, and prostate cancer.

Many such men simply will feel better and more vital when they have increased testosterone levels with HRT. Dr. Baiju Shah, an endocrinologist and researcher with Torontos Institute of Clinical Evaluation Sciences, questions the task forces recommendation to treat men with replacement therapy even when their testosterone levels are low or normal. For men who want to maintain fertility rather than ease symptoms, the task force recommended that they not receive testosterone treatment.

For men who have metastatic prostate cancer, the task force recommends against therapy to address testosterone deficiency. Men who have been diagnosed with testosterone deficiency without a contraindication should be treated with testosterone. In general, hypogonadal men who are asymptomatic with no effect on their quality of life should not receive testosterone therapy. An alternate diagnosis should be considered for patients who do not symptomatically respond, despite normalization of testosterone levels and an appropriate trial of therapy–about three months (lower LE, weaker recommendation).

If other conditions or medications are responsible for lowering testosterone levels, doctors generally will treat the primary problem before TRT is recommended. As such, Health Canada advises that TRT should not be used for men with symptoms not related to a condition, unless laboratory tests have confirmed a low level of testosterone, and that evaluation for cardiovascular disease is critical before prescribing TRT. According to the criteria of the LUC, laboratory tests are required prior to a prescription of TRT to confirm a patients low testosterone levels. Currently, 40-80% of patients receiving TRT in Ontario are likely not meeting minimum LU criteria, and some of those patients are not tested for low testosterone prior to receiving therapy.

While new national guidelines say diagnosis and treatment of low testosterone is highly controversial, with evidence of questionable quality, they state men who are low need to receive replacement therapy for most cases, even when presenting with stable cardiovascular disease. TRT, or Androgen Replacement Therapy (ART), is the treatment doctors prescribe for men who have testosterone deficiency and are showing symptoms of hypogonadism. TRT is traditionally used to treat hypogonadism, which occurs when your testes, also called gonads, do not make enough testosterone. The main purpose of testosterone therapy is to alleviate the negative signs and symptoms of TD or hypogonadism, and to increase your quality of life, by reaching eugonadal (normal) levels of testosterone.5 The benefits of therapy will vary depending on each patients constellation of symptoms.