In his talk, “Testosterone Replacement Modalities: Pros, Cons, and Their Correct Use,” Shehzad Sultan Basaria, MD, will discuss the benefits and drawbacks of various forms of treatments so clinicians can better inform their patients with hypogonadism.
By now, the controversy surrounding testosterone therapy and the shady advertising schemes promulgating the idea of “andropause” in aging men in order to sell more product is well documented. Putting such controversy aside for a moment, an upcoming Clinical Endocrinology Update (CEU) session will home in on another aspect of testosterone therapy — how best to prescribe it.
“In my talk, I will be discussing various testosterone formulations that are available,” explains Shehzad Sultan Basaria, MD, of the Brigham and Women’s Hospital in Boston, Mass. “I’m going to go over pros and cons of these formulations for the audience of clinicians. I will also discuss when to measure serum testosterone levels based on the formulation that the patients are using.” Basaria will moderate the session “Testosterone Replacement Modalities: Pros, Cons, and Their Correct Use” in both Miami, Fla. and Seattle, Wash.
Talking About Testosterone
Despite some of the findings to have emerged from the recent Testosterone Trials over the last few years as well as the continued uncertainty about the risks and benefits of testosterone therapy, the fact remains that many men with low testosterone levels seek treatment. According to “Testosterone Therapy in Men with Hypogonadism: An Endocrine Society Clinical Practice Guideline,” published in March 2018 in The Journal of Clinical Endocrinology & Metabolism, men should be diagnosed with hypogonadism when they exhibit specific signs and symptoms of androgen deficiency and “unequivocally and consistently” low serum testosterone by a validated test.
“The Testosterone Trial published in 2015 was an efficacy trial; there are other trials that have evaluated benefits as well as risks,” Basaria says. “But my talk will not address these aspects; it will be focused on various formulations available. It is important to understand that, although each formulation has its own specific advantages and disadvantages, the benefits and risks of testosterone replacement are a product of testosterone itself. Because the same hormone is being administered by different means, an endocrinologist should be able to titrate the dose of any formulation of testosterone to ensure the levels achieved are physiologic, although sometimes it can be a challenge,” he says.
“It is important to understand that, although each formulation has its own specific advantages and disadvantages, the benefits and risks of testosterone replacement are a product of testosterone itself.” – Shehzad Sultan Basaria, MD, Brigham and Women’s Hospital, Boston, Massachusetts
So, while the debate over risks and benefits continues in the background, let’s get a preview of how to arrive at optimal prescribing practice for those men who warrant treatment. Many factors go into this decision-making process, and no two patients will look exactly alike.
Basaria explains that his upcoming talk is the product of various papers published over the past six decades and the data that has accumulated on the different testosterone formulations, from the injections that came out in the mid 1900s, to the transdermal patches and gels now also available, to newer formulations such as intranasal gels, buccal tablets, and pellet implants. Basaria will walk through this dizzying array of offerings and discuss their various positive and negative attributes, how to use them, and when the patient should use the formulation — such as whether to apply a gel or patch at night or during the day or when during the day to use another type of formulation. Importantly, he will also be talking about post-prescribing monitoring.
“Based on the formulation a patient has been prescribed, what is the ideal time to check on treatment serum testosterone concentrations so that dose adjustments can be made?” Basaria says. “For example, if a patient is on weekly testosterone injections, the best time to check testosterone is midpoint between the injections. If he is taking testosterone patches that are applied at nighttime, the best time to measure testosterone is three to ten hours after application of the patch. If he is taking testosterone gel, his levels can be checked at any time after one week of treatment. Different formulations have different schedules of measurement of testosterone, so I will be talking about those things as well,” he says.
Pros and Cons
Globally, intramuscular injections are widely used formulation of testosterone. They are also the oldest and therefore the most time-tested formulation. “For injections, the advantages include predictable on-treatment levels of testosterone. If a patient uses weekly injections, that will result in physiologic levels of testosterone. But, to avoid the weekly needlestick, patients and clinicians usually opt for a higher dose, which is given twice a month.”
The con, however, is that this less-frequent dosing results in peaks and valleys in serum testosterone concentrations. The weekly smaller dose, despite the inconvenience, yields more even levels. “It is also inexpensive,” Basaria adds. “For the many patients who do not have insurance or have limited coverage, injections are one formulation that they can afford.”
“Because the same hormone is being administered by different means, an endocrinologist should be able to titrate the dose of any formulation of testosterone to ensure the levels achieved are physiologic, although sometimes it can be a challenge.” – Shehzad Sultan Basaria, MD, Brigham and Women’s Hospital, Boston, Massachusetts
Regarding patches, Basaria reports that they, too, provide predictable levels of serum testosterone. “The con,” he says, “is that a sizeable number of patients will complain of skin irritation where the patch has been applied.”
A popular formulation in the U.S., testosterone gels have the advantage of being convenient and easy to apply. On the other hand, the levels they deliver are comparatively less predictable. “The other con is the need to take certain precautions when using the gel,” Basaria says. “For example, the site of application must be covered after applying the gel because there have been cases of transmission of the gel to children.”
Basaria will go over advantages and disadvantages of the less commonly used formulations of testosterone in his talk as well.
— Horvath is a freelancer writer based in Baltimore, Md. She wrote about the link between obesity and precocious puberty in boys in the July issue.