Androgen Replacement Therapy (ART)
Description:
Androgen replacement therapy (ART), often referred to as testosterone replacement therapy (TRT), is a form of hormone therapy in which androgens, often testosterone, are replaced. ART is often prescribed to counter the effects of male hypogonadism. It typically involves the administration of testosterone through injections, skin creams, patches, gels, or subcutaneous pellets. ART is also prescribed to lessen the effects or delay the onset of normal male aging. However, this is controversial and is the subject of ongoing clinical trials. As men enter middle age they may notice changes caused by a relative decline in testosterone: fewer erections, fatigue, thinning skin, declining muscle mass and strength, and/or more body fat. Dissatisfaction with these changes causes some middle age men to seek ART.
Uses:
Hormone replacement therapy is a bit of a misnomer. It’s natural for men’s testosterone levels to decrease as they get older. So, hormone therapy doesn’t replace anything that is naturally missing.
Testosterone is required for: male sexual development, reproductive function, building muscle bulk, maintaining healthy levels of red blood cells, maintaining bone density.
However, the natural decrease of this hormone in men typically doesn’t affect overall health any more than the aging process does. Medical experts disagree about the significance of a testosterone level decrease. They also disagree about the health benefits of hormone therapy use to combat the natural aging process in men, especially given the risks.
Some men with unnaturally low levels of testosterone can benefit from hormone therapy. For example, the condition hypogonadism can cause unnaturally low levels of testosterone. It’s a dysfunction of the testicles that prevents the body from producing the right amount of testosterone. What’s less certain is whether testosterone therapy can benefit healthy men whose testosterone decline is simply caused by aging. This has been a difficult question for researchers to answer. Not many studies have observed the effects of testosterone therapy in men with healthy levels of the hormone. The studies that have were smaller and had unclear results.
Androgen replacement is the classic treatment of hypogonadism. It is also used in men who have lost the ability to produce androgens due to disease or its treatment.
The risks of diabetes and of testosterone deficiency in men over 45 (i.e., hypogonadism, specifically hypoandrogenism) are strongly correlated. Testosterone replacement therapies have been shown to improve blood glucose management. Still, “it is prudent not to start testosterone therapy in men with diabetes solely for the purpose of improving metabolic control if they show no signs and symptoms of hypogonadism.”
Side Effects:
The Food and Drug Administration (FDA) stated in 2015 that neither the benefits nor the safety of testosterone have been established for low testosterone levels due to aging. The FDA has required that testosterone labels include warning information about the possibility of an increased risk of heart attacks and stroke.
On January 31, 2014, reports of strokes, heart attacks, and deaths in men taking testosterone-replacement led the FDA to announce that it would be investigating this issue. The FDA’s action followed three peer-reviewed studies of increased cardiovascular events and deaths. Due to an increased rate of adverse cardiovascular events compared to a placebo group, a randomized trial stopped early. Also, in November 2013, a study reported an increase in deaths and heart attacks in older men. Even after a correction was published, the “Androgen Study Group”, a group with many members who have relationships with drug companies in the testosterone market, requested JAMA to retract the article as misleading due to substantial residual errors. Concerns have been raised that testosterone was being widely marketed without the benefit of data on efficacy and safety from large randomized controlled trials. As a result of the “potential for adverse cardiovascular outcomes”, the FDA announced, in September 2014, a review of the appropriateness and safety of testosterone replacement therapy.
Other significant adverse effects of testosterone supplementation include acceleration of pre-existing prostate cancer growth in individuals who have undergone androgen deprivation; increased hematocrit, which can require venipuncture in order to treat; and, exacerbation of sleep apnea. Adverse effects may also include minor side-effects such as acne and oily skin, as well as, significant hair loss and/or thinning of the hair, which may be prevented with 5-alpha reductase inhibitors ordinarily used for the treatment of benign prostatic hyperplasia, such as finasteride. Exogenous testosterone may also cause suppression of spermatogenesis, leading to, in some cases, infertility. It is recommended that physicians screen for prostate cancer with a digital rectal exam and prostate-specific antigen (PSA) level before starting therapy, and monitor PSA and hematocrit levels closely during therapy.
Administration:
There are several artificial androgens, many of which are manipulations of the testosterone molecule referred to as anabolic-androgenic steroids. Androgen replacement is administered by patch, tablet, capsule, cream or gel; or depot injections given into fat or muscle.
If your doctor suggests testosterone therapy, several options are available. These include:
– Intramuscular testosterone injections: Your doctor will inject these into the muscles of your buttocks every two to three weeks.
– Testosterone patches: You apply these each day to your back, arms, buttocks, or abdomen. Be sure to rotate the application sites.
– Topical testosterone gel: You apply this each day to your shoulders, arms, or abdomen.
