TRT (Testosterone Replacement Therapy) at Men's Clinics and Med Spas

Testosterone replacement therapy (TRT) is prescription testosterone given to men whose bodies do not make enough of the hormone on their own.

FDA-approved testosterone products, such as Depo-Testosterone (testosterone cypionate), are indicated for replacement therapy in males with conditions associated with a deficiency or absence of endogenous testosterone — the testosterone the body produces itself.

FDA's approval has a boundary that matters when you evaluate men's clinics.

FDA says testosterone is approved solely for use in men who lack or have low testosterone in conjunction with an associated medical condition, and the labels keep a limitation stating that safety and efficacy for "age-related hypogonadism" (also called "late-onset hypogonadism") have not been established.

TRT is a medical treatment, not a spa service.

Men's health clinics and med spas that sell TRT programs are dispensing a Schedule III controlled substance that requires a prescription from a licensed prescriber — and the label's process adds lab work to confirm the diagnosis and follow-up testing, which is what the rest of this page covers.

Whether you need TRT is a medical question that starts with blood work.

The Depo-Testosterone label tells prescribers to confirm the diagnosis of hypogonadism before starting therapy: serum testosterone measured in the morning on at least two separate days, with both results below the normal range.

Symptoms are part of the picture too.

To enroll in the TRAVERSE trial — the study whose results FDA added to the class-wide labels in 2025 — men had to report symptoms of hypogonadism and have two fasting testosterone levels below 300 ng/dL.

We could not confirm from our sources which symptoms an individual clinic will accept as part of the diagnosis, or what threshold each provider uses.

Those are decisions for the licensed provider who examines you, and they are worth asking about directly.

A clinic that prescribes on the strength of a single blood draw, or without the confirmatory morning testing the label describes, is not following the labeled process.

Ask any provider how it confirms the diagnosis before it writes a prescription.

FDA says the current approved testosterone formulations include oral, topical gel, transdermal patch, buccal system (applied to the upper gum or inner cheek) and injection.

The Depo-Testosterone (testosterone cypionate) injection label gives 50 to 400 mg every two to four weeks for replacement in hypogonadal men, with the dose adjusted to response and side effects.

That is the range the label gives; it is not a target to ask for, and your own dose is the prescriber's decision.

Pellets are solid doses of testosterone placed under the skin (subcutaneous implantation).

The one FDA-approved pellet product our research found is Testopel — testosterone pellets of 75 mg each, for subcutaneous implantation, indicated for testosterone replacement in males with primary or hypogonadotropic hypogonadism.

We could not confirm from our sources whether other pellet products on the market are FDA-approved, so ask any clinic exactly which product it implants.

Clinics may also offer compounded or "bioidentical" hormones. "Bioidentical" and "compounded" are not the same thing: FDA has approved many hormone products, including testosterone, that were reviewed for safety and efficacy, while compounded "BHRT" blends are not FDA-reviewed.

A 2020 National Academies report commissioned by FDA concluded there is insufficient evidence to support the clinical utility of compounded bioidentical hormone therapy for menopause or male hypogonadism symptoms, and recommended restricting its use.

Testosterone is not an ordinary prescription drug.

Federal law lists testosterone — including its salts, esters and ethers — as a Schedule III controlled substance, under the anabolic steroid listing in 21 CFR 1308.13(f).

That status shapes what a legitimate TRT provider looks like.

Schedule III prescriptions must come from a licensed prescriber with DEA registration.

Prescribing by telemedicine has its own federal rule.

Under the Ryan Haight Act, a practitioner normally may prescribe a controlled substance by telemedicine only after at least one in-person medical evaluation.

During and after the COVID pandemic, DEA and HHS have repeatedly suspended that in-person requirement.

The fourth temporary extension keeps the COVID-era telemedicine flexibilities — no in-person visit required — in effect from January 1, 2026 through December 31, 2026.

As of October 2026 the federal rule therefore does not require an in-person visit before testosterone is prescribed by telemedicine, but it has an end date and could change, and we could not confirm from our sources whether state rules add their own requirements; confirm the current requirements with any clinic you are considering.

Ask a clinic directly who writes its prescriptions, whether that prescriber holds a DEA registration, and whether your visits would be in person or by telehealth.

TRT is not a one-time prescription.

The Depo-Testosterone label calls for hemoglobin and hematocrit levels to be checked periodically in patients receiving long-term androgen administration, to detect polycythemia.

Blood pressure belongs on the same list.

FDA says ambulatory blood pressure studies confirmed testosterone raises blood pressure across the class, and the label tells prescribers to monitor blood pressure periodically.

Testosterone products are not recommended for patients with uncontrolled hypertension.

The labels our research covers give these requirements, but no standard calendar of visits or blood draws, so we cannot tell you how often a particular clinic should test.

Ask any provider for its written monitoring plan: which tests, how often, and who reviews the results.

Monitoring is also where a program shows its quality.

A clinic that prescribes at a first visit and never retests is not following the labeled requirements for long-term therapy.

The TRAVERSE trial (Lincoff et al., NEJM 2023) followed 5,246 men aged 45 to 80 who had hypogonadism and either established cardiovascular disease or a high risk of it.

Participants received a testosterone gel or a placebo.

For major adverse cardiac events, the testosterone gel was noninferior to placebo: 7.0% in the testosterone group versus 7.3% on placebo (hazard ratio 0.96).

Noninferiority means the trial was designed to detect whether testosterone made cardiac events meaningfully worse, and the result did not cross that threshold in this population.

Noninferiority is not a clean bill of health. Atrial fibrillation, acute kidney injury and pulmonary embolism were all more frequent in the testosterone group.

FDA responded with class-wide labeling changes announced on February 28, 2025: the labels added the TRAVERSE results and removed the boxed-warning language about increased cardiovascular risk, kept the limitation of use for age-related hypogonadism, and added or strengthened warnings about increased blood pressure.

The labels also note postmarketing reports of venous blood clots, including deep vein thrombosis and pulmonary embolism.

Fertility is a known effect rather than a mystery.

The label explains that outside testosterone inhibits pituitary LH and, at large doses, FSH, which may suppress sperm production, and that low sperm counts (oligospermia) may occur with prolonged use or excessive dosage.

Men who may want children should raise this with the prescriber before starting.

The prostate question has a specific label answer.

Depo-Testosterone is contraindicated in men with known or suspected prostate cancer.

The label says older men treated with androgens may be at increased risk of prostatic enlargement and prostate cancer, while also stating that conclusive evidence for this is lacking, and that men with benign prostatic hyperplasia (BPH) may develop acute urinary obstruction.

Both extremes you will see online overshoot the evidence.

The trial showed noninferiority for cardiac events in one studied population — a result that does not establish TRT as heart-safe in general — and the labels describe prostate risk as unproven while still directing caution.

We could not confirm a national reference price for TRT.

Our research found no figure from a named survey or professional body, so treat any single number you see online with caution.

What we can describe is the structure. A TRT program's price can combine several parts: the testosterone product itself, supplies, initial lab work, and repeat testing and follow-up visits over time.

The form of testosterone can also change what you pay for over time — a gel is a recurring purchase, while pellets involve an implantation procedure.

When you compare clinics, ask exactly what a quoted price includes: which product and whether it is FDA-approved, whether lab work is included or billed separately, how often you will be seen, and what happens if you stop.

We also could not confirm from our sources how insurers treat TRT, so ask your insurer and the clinic directly.

And ask whether the program is month to month or a contract before you commit.

TRT is offered by men's health clinics, med spas and wellness practices, and by telehealth programs.

The label's requirements do not change with the setting: the diagnosis should rest on morning blood tests on two separate days, both below the normal range, before therapy starts, the prescription must come from a licensed prescriber with DEA registration, and the labels call for periodic blood counts and blood pressure checks during long-term use.

The person writing your prescription matters more than the waiting-room decor.

The questions below are ones any legitimate program should answer in plain terms.

If a clinic will not answer these questions in plain terms, treat that as its answer.

TRT is a long-term medical treatment with real label warnings, and it deserves a provider who runs it that way.