Testosterone Replacement Therapy in Charleston and Mt. Pleasant, SC

Reviewed by Ashley Harwyn, PA-C  |  A4M Board Certified  |  Updated September 4, 2026

Testosterone replacement therapy is one of the most heavily marketed treatments in men's health and one of the most narrowly approved. Both of those things are true at once, and the gap between them is where most of the confusion lives. This page works from the guideline and the trial data rather than from the advertising.

How is low testosterone actually diagnosed?

Not on symptoms, and not on one blood test. The AUA guideline is specific: the diagnosis of low testosterone should be made only after two total testosterone measurements are taken on separate occasions, with both conducted in an early morning fashion[1]. A total testosterone below 300 ng/dL is the cut-off the guideline calls reasonable in support of the diagnosis.

Two things follow from that sentence, and both matter more than they sound. The first is timing. Testosterone follows a daily rhythm and falls through the day, so an afternoon draw can read low in a man whose morning level is entirely normal. The second is repetition. A single value, even a morning one, is not the diagnosis. It is one of two.

What else is measured before anything is prescribed

Hemoglobin and hematocrit, because testosterone raises red cell concentration and the guideline directs clinicians to measure both and inform patients of the increased risk of polycythemia[1]. That is the most predictable adverse effect of the treatment and the easiest to catch early.

PSA in men over 40, before starting, to exclude a prostate cancer diagnosis[1]. Note what that is for. It is not because testosterone is thought to cause prostate cancer. It is to know what is already there before treatment begins. Those are different reasons and they get conflated constantly. Both are part of a proper baseline lab panel.

What does the evidence say testosterone actually does?

This is the question most pages skip, so here is the guideline's own answer. The AUA states that patients should be informed that the evidence is inconclusive whether testosterone therapy improves cognitive function, measures of diabetes, energy, fatigue, lipid profiles and quality of life measures[1].

Read that list again, because it is close to the entire advertising claim of the men's clinic category. Energy. Focus. Metabolism. Vitality. The professional body that wrote the guideline on this treatment says the evidence for those outcomes is inconclusive. Some men on therapy do feel better, and that experience is real. What no clinician can honestly do is promise it in advance.

What the guideline does support is treating a confirmed deficiency in men who have one, and it notes separately that low testosterone is itself a risk factor for cardiovascular disease[1]. That is a reason to measure it properly rather than a reason to treat everyone.

Is testosterone therapy safe for your heart?

The largest trial ever run on this question is TRAVERSE, published in the New England Journal of Medicine in 2023. It randomized 5,246 men aged 45 to 80 who had two fasting testosterone levels below 300 ng/dL and either existing or high-risk cardiovascular disease[2].

Major adverse cardiac events occurred in 182 men on testosterone, 7.0 percent, and 190 men on placebo, 7.3 percent. The hazard ratio was 0.96 with a 95 percent confidence interval of 0.78 to 1.17, meeting the trial's noninferiority threshold[2]. In plain terms, testosterone did not raise the rate of heart attacks, strokes and cardiovascular deaths in this group.

The same trial found three things that were more common in the testosterone group: atrial fibrillation, acute kidney injury and pulmonary embolism[2]. Those belong in the conversation, and they are the part that tends to go missing when the trial gets summarized as proof of safety.

What the FDA changed in 2025

On February 28, 2025 the FDA issued class-wide labeling changes for testosterone products. It removed the language in the Boxed Warning relating to an increased risk of adverse cardiovascular outcomes, on the basis of TRAVERSE and the required postmarket blood pressure studies[3].

It also added a new warning about increased blood pressure, and product-specific blood pressure information for the products with completed ambulatory monitoring studies[3]. So the label got better in one place and stricter in another on the same day. Anyone citing only the first half is citing half a document.

Does testosterone cause prostate cancer?

No, and the guideline asks clinicians to say so. AUA statement 17 is that clinicians should inform patients of the absence of evidence linking testosterone therapy to the development of prostate cancer, and it carries a strong recommendation[1].

This matters because the opposite belief is widespread, including in patient-facing material written by clinics themselves. A man who declines treatment he actually needs because of a risk that the evidence does not support has been failed by the information, not by the medicine.

The picture is genuinely different for men with a prior prostate cancer history. There the guideline says patients should be informed that there is inadequate evidence to quantify the risk and benefit of testosterone therapy[1]. That is an honest statement of uncertainty, and it usually means a conversation with your urologist as well as with us.