Testosterone replacement therapy (TRT)

TRT is a prescription treatment for lab-confirmed testosterone deficiency, and testosterone is a controlled substance with label limits on who it is approved for.

What it treats

testosterone deficiency diagnosed from symptoms and at least two morning blood tests^3,4

What the label says

testosterone is approved for men with low testosterone caused by certain medical conditions; safety and effectiveness for low testosterone due to aging alone have not been established^1,2

Medication

your provider chooses the medication and form that fit your labs and history

Compounded medications

some prescribed medications may be compounded. Your provider tells you which applies to you (see the notice below)

Controlled substance

yes, Schedule III. It can be misused, and abuse and dependence have been reported¹

Main risks

higher blood pressure and red blood cell count, lower sperm production and fertility; prostate and blood-level monitoring^1,5

Before you start

morning testosterone labs, a blood count, a prostate check (PSA) where indicated, and a visit with a licensed provider³

Monitoring

periodic follow-up labs for testosterone, red blood cell count (hematocrit) and PSA, blood pressure readings you share with your provider, and provider reviews^1,3

Office or video

at your local office or by secure video. Some states require an in-person exam first

A licensed provider decides whether treatment is right for you only after your coordinator call and your lab results.

A call with your coordinator

Your coordinator talks with you about your symptoms and goals, explains each step and its cost, and books your labs. You keep the same coordinator, with a direct line, while you're a patient.

Labs first

A morning blood panel at a lab near you, ordered for you, before your first visit. In most cases you can walk in. Some offices can also draw your blood. The testosterone panel

Your first visit

At your local office or by secure video. Your provider goes through your symptoms, history and results, checks for reasons not to start, and explains the options and the risks.

If treatment fits

Your provider chooses the medication and form that fit your labs and history and explains your treatment plan. Your coordinator then goes over the order and its cost with you before you pay. The supply is paid in full up front for a set period. If treatment doesn't fit, nothing is prescribed, and your provider explains why and what else to look at.

Follow-up

Coordinator check-ins, and periodic follow-up labs and provider reviews while you're on treatment. Your provider can change or stop the plan based on the results. Each new supply needs your provider's prescription and your OK. Follow-up labs on TRT

How it works, step by step

The evidence supports a narrow set of benefits in men with confirmed deficiency, and it comes with risks your provider monitors.

In a large placebo-controlled trial of men aged 45 to 80 with heart disease or high cardiovascular risk, two testosterone results below 300 ng/dL and low libido, testosterone improved sexual activity, sexual desire and hypogonadal symptoms over two years. It did not improve erectile function.⁷ The Endocrine Society states that symptoms alone don't diagnose low testosterone, and that common complaints such as low energy and mood have many causes, which a provider rules out first.⁴

Your provider chooses the medication and form that fit your labs and history, and explains why, including whether a medication is compounded. Testosterone in any form lowers sperm production and needs follow-up labs.

Reasons guidelines list for not starting include

Your provider checks for these and other reasons before treatment is discussed.³

• Plans to have children in the near term
• Breast or prostate cancer
• A prostate lump or hardened area, or a raised PSA, without further urology evaluation
• A high red blood cell count (elevated hematocrit)
• Untreated severe obstructive sleep apnea
• Severe lower urinary tract symptoms
• Uncontrolled heart failure, or a heart attack or stroke in the past 6 months
• Thrombophilia, a tendency to form blood clots

Testosterone can raise blood pressure and red blood cell count, and it lowers sperm production. Follow-up labs track your testosterone level, hematocrit and PSA while you're on treatment, and your provider can change or stop the plan.^1,3,5

Testosterone is a controlled substance because it can be misused. Abuse and dependence have been reported, mostly at doses above those prescribed, and stopping high doses abruptly can cause withdrawal symptoms. Take it only as your provider directs.¹

In the TRAVERSE trial, men at high cardiovascular risk had about the same rate of heart attack, stroke and cardiovascular death on testosterone as on placebo, and more atrial fibrillation, acute kidney injury and pulmonary embolism.⁶ The Endocrine Society adds that the trials also showed more bone fractures and that long-term safety, including for prostate cancer, is not established.⁴ TRT safety and monitoring

You pay for each step as you reach it: your lab panel, a provider fee that covers your provider's visits and reviews for a set period and, if your provider prescribes treatment, a medication supply that is paid in full up front for a set period.

Costs are explained before you pay, and you get a receipt by email. No long-term contract and no automatic billing. Each supply needs your provider's prescription and your OK, and you decide whether to order the next one. How pricing works

Start at your local office, or by secure video where your state allows. Enter your ZIP, or choose your state above, to see the offices that apply to you.

Prescription treatment requires an evaluation by a licensed healthcare provider, who decides whether treatment is appropriate for you. Not everyone qualifies. Completing an assessment, booking a visit, or paying a fee does not guarantee a prescription.

Testosterone labels changed in 2025, and in June 2026 FDA asked for more changes that are not yet in the labels.

• February 2025. FDA required blood-pressure warnings on all testosterone products and added results from the TRAVERSE heart-safety trial to the labels.^5,6
• June 2026. FDA asked makers to update testosterone labels, including removing the limitation of use for age-related hypogonadism. Until new labels are approved, the current labels still say safety and effectiveness for low testosterone due to aging alone have not been established.²
• July 2026. The Endocrine Society restated that symptoms alone don't diagnose low testosterone and that at least two early-morning tests are needed.⁴
• November 1, 2026. A current reference label on DailyMed (effective August 21, 2026) still carries the limitation of use.¹

1. DailyMed. Testosterone cypionate, prescribing information: indications (limitation of use), warnings, drug abuse and dependence (Pharmacia & Upjohn; label effective 2026-08-21) dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfbb53d4-b868-4a28-8436-f9112eb01c39
2. FDA. Testosterone Information (content current as of 06/23/2026) www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/testosterone-information
3. Bhasin S, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744 (abstract) pubmed.ncbi.nlm.nih.gov/29562364/
4. Endocrine Society. Statement on Testosterone Replacement Therapy. July 16, 2026 www.endocrine.org/news-and-advocacy/news-room/2026/statement-on-testosterone-replacement-therapy
5. FDA. FDA issues class-wide labeling changes for testosterone products. February 28, 2025 www.fda.gov/drugs/drug-alerts-and-statements/fda-issues-class-wide-labeling-changes-testosterone-products
6. Lincoff AM, et al. Cardiovascular Safety of Testosterone-Replacement Therapy (TRAVERSE). N Engl J Med. 2023;389:107-117 (abstract) pubmed.ncbi.nlm.nih.gov/37326322/
7. Pencina KM, et al. Effect of Testosterone Replacement Therapy on Sexual Function and Hypogonadal Symptoms in Men with Hypogonadism (TRAVERSE Sexual Function Study). J Clin Endocrinol Metab. 2023 (abstract) pubmed.ncbi.nlm.nih.gov/37589949/
8. DEA and HHS. Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. 90 FR 61301, FR Doc. 2025-24123 (effective January 1, 2026 through December 31, 2026) www.federalregister.gov/d/2025-24123

• Low testosterone symptoms in men
• What a morning testosterone blood test measures
• TRT telehealth and the Dec 31, 2026 DEA deadline

Medical services are provided by independently licensed physicians, nurse practitioners and physician assistants of affiliated professional corporations and their affiliated professional entities. Vitality Testosterone Replacement Therapy provides administrative and technology support and does not practice medicine. All treatment decisions are made at the sole discretion of the treating provider. Medications are dispensed by licensed pharmacies. This website is an advertisement for medical services and is not medical advice. If you have a medical emergency, call 911.