American College of Physician (ACP) committee conducted a systematic review of 38 randomized controlled clinical trials focusing on testosterone supplementation in individuals with age-related hypogonadism. The study participants had an average age of 66 years and baseline total testosterone measures ≤300 ng/dL. After careful analysis, the authors of the review reached a consensus and provided the following recommendations:
- Physicians should consider initiating testosterone therapy in adults with age-related hypogonadism, primarily for the management of sexual dysfunction. The decision to proceed with treatment should be made after a thorough discussion between the patient and the physician. This discussion should cover various aspects, including available pharmacological options, potential benefits, safety considerations, and cost implications.
- The ACP recommends using the intramuscular route for testosterone administration due to its cost-effectiveness and comparable efficacy and safety when compared to other modes of therapy. However, they do not advise initiating testosterone supplementation for addressing symptoms other than sexual dysfunction, such as reduced physical capacity, cognition, stamina, or vitality.
A gradual, age-associated decline in serum total testosterone levels begins in men in their mid 30s and continues at an average rate of 1.5% per year. This condition is referred to as age-related low testosterone and is accompanied by the following clinical symptoms:
- Sexual function, physical function, quality of life, energy and vitality, depression, cognition, serious adverse events, major adverse cardiovascular events, and other adverse events.
No well-defined, universally accepted threshold of testosterone levels exists below which symptoms of androgen deficiency and adverse health outcomes occur.
The incidence of low testosterone in the United States is reported to be approximately:
- 20% in men older than 60 years
- 30% in those older than 70 years
- 50% in those older than 80 years
- ACP suggests that clinicians discuss whether to initiate testosterone treatment in men with age-related low testosterone with sexual dysfunction who want to improve sexual function. This is a conditional recommendation of low-certainty evidence. The discussion should include the potential benefits, harms, costs, and patient’s preferences.
- ACP suggests that clinicians should reevaluate symptoms within 12 months and periodically thereafter. Clinicians should stop testosterone treatment in men with age-related low testosterone with sexual dysfunction in whom there is no improvement in sexual function. This is also a conditional recommendation of low-certainty evidence.
- ACP suggests that clinicians consider intramuscular rather than transdermal formulations when initiating testosterone treatment to improve sexual function in men with age-related low testosterone, as costs are considerably lower for the intramuscular formulation and clinical effectiveness and harms are similar.
- ACP suggests that clinicians do not initiate testosterone treatment in men with age-related low testosterone to only improve energy, vitality, physical function, or cognition – without concerns of sexual dysfunction. This is a conditional recommendation of low-certainty evidence.