Testosterone replacement therapy, explained by a physician
Testosterone replacement is a prescription hormone for men whose symptoms and repeated morning blood tests show a true deficiency. It is a Schedule III controlled substance, it can lower sperm production, and it needs lab monitoring for as long as you take it. Where a telehealth clinic can prescribe it depends on federal and state rules, so access is never assured.
Information current as of November 10, 2026. Educational only. Confirm everything here with your own clinician before starting, stopping or changing any medication.
At a glance
Drug class
Androgen hormone. Schedule III controlled substance under federal law.
How it is taken
Injection, gel, nasal gel, pellet or capsule, depending on the product.
Approval status
FDA-approved products exist for men with low testosterone from a medical cause. Labels say safety and benefit for age-related decline alone are not established. No testosterone product is FDA-approved for women.
Who it is for
Men with symptoms plus two low morning total testosterone results. Not for men planning a pregnancy soon.
Main cautions
Higher red blood cell count, blood pressure rise, clot risk, lower sperm count, and abuse and dependence warnings.
What it is
What testosterone therapy does, and what it does not
Testosterone is the main male sex hormone. It supports sex drive, erections, muscle, bone and red blood cell production. Testosterone therapy replaces it from outside the body. The goal is to bring a measured low level back to the normal range and ease symptoms that come from the deficiency.
It is not a general energy booster, and it does not treat a normal level. The Endocrine Society guideline says to diagnose hypogonadism only in men with symptoms and signs consistent with deficiency and unequivocally and consistently low blood levels. Treatment is a long-term commitment. It does not fix a cause such as poor sleep, obesity or opioid use, so those get checked first.
We cover the basics for patients in our testosterone therapy overview and our TRT for men guide. If you are also on a weight-loss medication, this page covers how weight loss and testosterone interact. This page goes deeper on labels, trials and rules.
Diagnosis
How a deficiency is confirmed
One low number is not enough. Testosterone swings through the day and drops after a poor night of sleep, an illness or a big meal. Both major US guidelines ask for two early-morning total testosterone measurements, plus symptoms. The 2018 Endocrine Society guideline asks for fasting morning samples. The 2018 AUA guideline treats a total testosterone below 300 ng/dL as a reasonable cutoff. Summit uses symptoms plus two morning totals below 300.
If your total is near the lower limit of normal, or a condition changes sex hormone-binding globulin, a free testosterone may be needed. A physician then looks for the cause with LH, FSH and other labs. That step matters because the cause decides the treatment. A man whose pituitary signal is low and who wants children may do better with a different approach (see clomiphene).
- Symptoms that count: low sex drive, erectile changes, low energy, low mood, loss of muscle, and reduced body hair.
- Often sent for before starting: hematocrit, PSA, LH, FSH, estradiol and a review of sleep apnea risk.
Formulations
Formulations and what the labels say
All FDA-labeled testosterone products are indicated for men with low testosterone from a medical condition, such as testicular or pituitary disease. In February 2025 the FDA announced class-wide label changes after TRAVERSE and its blood pressure studies. It kept the Limitation of Use for age-related hypogonadism, added the TRAVERSE results to every label, removed boxed warning language about cardiovascular outcomes, and required a blood pressure warning on every testosterone product.
Injectable cypionate and enanthate
Generic oil-based vials, given into muscle. The cypionate label gives a dosing interval of two to four weeks, and many clinicians use smaller, more frequent doses to flatten the peaks and troughs. Lowest cost, but levels swing more between shots.
Subcutaneous enanthate (Xyosted)
A weekly autoinjector under the skin. Its label carries a blood pressure warning and states that safety and effectiveness in age-related hypogonadism are not established. The older boxed blood pressure warning was removed in the 2025 update.
Gels (for example AndroGel)
Applied daily to the skin. The boxed warning is about secondary exposure: skin contact can transfer testosterone to a partner or child, and virilization has been reported in children. TRAVERSE used a 1.62% gel.
Pellets (Testopel)
Small pellets placed under the skin in a minor procedure and replaced every few months. The dose cannot be changed once they are in, so a high level has to be waited out. Infection and pellet extrusion can occur.
Nasal gel (Natesto)
Sprayed into each nostril several times a day. It avoids skin transfer, but the label carries the class blood pressure warning and nasal side effects are common.
Oral capsules (Jatenzo, Tlando, Kyzatrex)
Testosterone undecanoate taken with food. Their labels once carried a boxed blood pressure warning, removed in 2025 updates, and still list blood pressure increases under Warnings and Precautions. Labels limit use to defined medical causes.
Warnings that appear across labels
- Higher hematocrit (polycythemia), which raises clot and stroke concern if it climbs.
- Venous thromboembolism, including deep vein thrombosis and pulmonary embolism.
- Blood pressure increases, which can happen even when you feel fine.
- Worsening of sleep apnea, enlargement of benign prostate tissue, and possible breast enlargement.
- Abuse and dependence: labels warn that doses above those prescribed have been linked to serious harm, and the drug is Schedule III.
Some pharmacies compound testosterone creams, troches or pellets. Compounded drugs are not FDA-approved, and the FDA does not evaluate them for safety, effectiveness or quality.
Evidence
What the major trials and guidelines show
TRAVERSE (2023): the cardiovascular safety trial
TRAVERSE enrolled 5,246 men aged 45 to 80 who had low testosterone with symptoms, and who already had or were at high risk for heart disease. They were assigned to a daily 1.62% testosterone gel or placebo gel. Mean treatment lasted about 21.7 months, and mean follow-up was about 33 months. A major cardiovascular event occurred in 7.0% of the testosterone group and 7.3% of the placebo group (hazard ratio 0.96, 95% CI 0.78 to 1.17). That met the trial’s noninferiority goal. Published reports of the trial also described more pulmonary embolism, atrial fibrillation and acute kidney injury in the testosterone group. The trial tested one gel in a high-risk group for under three years, so it does not answer every question about every product or longer use.
The Testosterone Trials (2016): what symptoms improve
This set of trials gave 790 men aged 65 or older, with a testosterone below 275 ng/dL and symptoms, either gel or placebo for one year. Treatment raised levels to the mid-normal range. It produced a moderate benefit in sexual function, some benefit in mood and depressive symptoms, and no benefit in vitality or walking distance. Benefit depends on which symptom you are trying to treat.
Guidelines
- Endocrine Society 2018: treat symptomatic men with confirmed deficiency after discussing benefits and risks. It recommends against starting therapy if you plan fertility soon, or have breast or prostate cancer, a palpable prostate nodule, PSA above 4 ng/mL (above 3 in higher-risk men without urology review), elevated hematocrit, untreated severe sleep apnea, severe urinary symptoms, uncontrolled heart failure, a heart attack or stroke in the last six months, or a clotting disorder. It aims for mid-normal levels on treatment.
- AUA 2018: built on a Mayo Clinic evidence review. It stresses accurate total testosterone measurement, tying treatment to symptoms, and structured monitoring, with separate statements for men with cardiovascular disease, prostate cancer, or an interest in fertility.
Fertility and testes
Fertility, sperm and testicular effects
Outside testosterone shuts down the brain signals (LH and FSH) that tell the testes to make sperm and their own testosterone. Sperm counts usually fall, sometimes to zero, and the testes often shrink. This effect is the reason both guidelines advise against starting therapy if you want a pregnancy soon. Recovery after stopping varies. Many men recover over months, and some take longer or do not return to baseline.
Testosterone is not birth control. If you may want children, say so before treatment. Other options may keep your own production going, such as clomiphene or hCG. Both are used off-label for this purpose. A baseline semen analysis is reasonable before any hormone therapy if fertility matters to you.
Monitoring
Monitoring: what gets checked and when
The Endocrine Society asks for a standard plan during the first year: review symptoms, side effects and adherence, measure testosterone and hematocrit, and assess prostate cancer risk. Repeat labs are commonly drawn at about three to six months after starting or changing a dose, then at least yearly once stable.
- Total testosterone: checked at a consistent point after a dose, because injections peak and trough.
- Hematocrit: the most common reason a dose is lowered or paused. A rising value means thicker blood.
- PSA: per guideline, with urology review for a high or rising value.
- Estradiol: testosterone converts to estradiol. It is checked when symptoms such as breast tenderness or swelling, or the lab pattern, call for it. If it runs high, anastrozole is sometimes discussed, and that is off-label in men.
- Symptoms and blood pressure: reviewed at every check. If you feel no better after a fair trial, the plan changes.
For women
Testosterone for women: a shorter, different story
Women make testosterone too, in much smaller amounts. No testosterone product is FDA-approved for women in the US, so any use is off-label. The 2019 Global Consensus Position Statement, endorsed by several menopause and endocrine societies, supports testosterone for postmenopausal women with hypoactive sexual desire disorder, when other causes have been addressed. It has not backed it for other uses. Doses are a small fraction of a man’s dose and are aimed at a premenopausal blood level.
Watching matters here. Labs check that levels stay in the female range, and the physician looks for acne, unwanted hair growth and voice change, which are signs of too much. Long-term safety data are limited. Men’s products are not interchangeable with a woman’s dose, and this page’s trial data apply to men.
Rules
Schedule III and the telehealth limits
Testosterone is a Schedule III controlled substance. Under the Ryan Haight Act (21 USC 829(e)), prescribing a controlled substance over the internet normally requires an in-person evaluation first. Since the pandemic, the DEA has allowed telemedicine prescribing without that visit through temporary extensions. The fourth extension runs through December 31, 2026. A permanent special-registration rule has not been published, so what happens after that date is not settled.
States add their own rules, and they differ. A state allowing telehealth prescribing does not remove the need for the prescriber to hold the right DEA registration for the patient’s state. Summit Men serves Tennessee, Georgia (only through December 31, 2026 under current rules), Florida and Washington. If you live elsewhere, or the rules change, a telehealth clinic may not be able to prescribe testosterone to you, and an in-person visit may be required.
Summit’s role
What Summit does and does not do with testosterone
Summit Men prescribes testosterone after a physician evaluation. We start with symptoms and two early-morning total testosterone results below 300, with labs included. Dr. Miranda reviews your history, medications, sleep, blood counts and prostate risk before deciding. He may decline, delay, or refer you if something is not safe, or if fertility is a priority.
- Prescribing depends on the state you live in and the rules in force on the day. We cannot promise anyone access.
- The product, dose and schedule are chosen for you. Monitoring labs are part of the care. Testosterone is Schedule III, so refills follow the rules for that class.
- Telehealth only. We do not sell brand-name products.
Costs are on the pricing page. Individual results vary.
Common questions
Questions people ask
Does testosterone therapy cause heart attacks or strokes?
In TRAVERSE, 5,246 men with or at high risk for heart disease used a testosterone gel for a mean of about 22 months. Major cardiovascular events were 7.0% with testosterone and 7.3% with placebo. The FDA then removed boxed warning language about adverse cardiovascular outcomes. Blood pressure, clots and red blood cell count remain real concerns, so monitoring continues.
Will testosterone make me infertile?
It can lower sperm production, sometimes to zero, because it suppresses the signals that drive the testes. Recovery after stopping varies and can take months or longer. If you want children soon, tell your physician first, because other approaches may keep production going.
Is testosterone a controlled substance?
Yes. It is Schedule III under federal law. That is why telehealth prescribing is limited by the Ryan Haight Act, by temporary DEA flexibilities currently running through December 31, 2026, and by state rules.
How often do I need blood work?
Guidelines call for a structured plan in the first year. Labs are commonly drawn about three to six months after starting or changing a dose, then at least once a year when stable. Your physician may check more often if a result is out of range.
Can women use testosterone?
No testosterone product is FDA-approved for women. A 2019 global consensus statement supports low-dose use for postmenopausal women with hypoactive sexual desire disorder. This is off-label and needs lab and symptom follow-up.
Can I get testosterone through telehealth in any state?
No. Rules vary by state and by federal law, and the prescriber must meet the requirements of the state where you are. Summit Men currently serves Tennessee, Georgia (through December 31, 2026), Florida and Washington. Access is never promised.
Sources
Where this comes from
All retrieved November 10, 2026.
- Lincoff AM, et al. Cardiovascular Safety of Testosterone-Replacement Therapy (TRAVERSE). N Engl J Med 2023. https://pubmed.ncbi.nlm.nih.gov/37326322/
- Bhasin S, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2018. https://pubmed.ncbi.nlm.nih.gov/29562364/
- Mulhall JP, et al. Evaluation and Management of Testosterone Deficiency: AUA Guideline. J Urol 2018. https://pubmed.ncbi.nlm.nih.gov/29601923/
- Snyder PJ, et al. Effects of Testosterone Treatment in Older Men (Testosterone Trials). N Engl J Med 2016. https://pubmed.ncbi.nlm.nih.gov/26886521/
- Davis SR, et al. Global Consensus Position Statement on the Use of Testosterone Therapy for Women. J Clin Endocrinol Metab 2019. https://pubmed.ncbi.nlm.nih.gov/31498871/
- FDA. FDA issues class-wide labeling changes for testosterone products. February 2025. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-issues-class-wide-labeling-changes-testosterone-products
- DailyMed. Testosterone cypionate injection prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f901e2b2-f143-4237-8e95-0d134585490b
- DailyMed. Xyosted (testosterone enanthate) prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a3d204c-be26-49e0-8599-0ac12a272e81
- DailyMed. AndroGel (testosterone) gel prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e8d29b-8707-4d47-e053-2a95a90aecee
- DailyMed. Jatenzo (testosterone undecanoate) prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ed7b5d41-7475-4c10-99b9-b62b3434ae60
- Federal Register. Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. December 31, 2025. https://www.federalregister.gov/documents/2025/12/31/2025-24123/fourth-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled
- Tennessee Board of Medical Examiners. Telemedicine frequently asked questions. https://www.tn.gov/content/dam/tn/health/documents/Telemedicine_FAQs.pdf
- Florida Statutes section 456.47. Use of telehealth to provide services. https://flsenate.gov/Laws/Statutes/2026/456.47
Confirm with your provider. This page is general education, not medical advice, and it does not diagnose or treat anything. Every medication carries risks and is not right for everyone. Medication is prescribed only after a physician evaluation determines it is appropriate for you. Individual results vary and no outcome is guaranteed. Information current as of November 10, 2026.
Next step
See whether treatment fits you
Apply and a physician reviews your history and labs first. Whether testosterone is right, and whether we can prescribe it in your state, is decided after that review.