What is testosterone replacement therapy (TRT), and who is it for?

On this page

• Overview
• How testosterone works
• Why people use it
• Does testosterone therapy work, and what do the trials show?
• Potential benefits
• Limitations
• Risks and side effects
• Contraindication considerations
• Administration methods
• What should I expect at a TRT appointment or session?
• How long until results?
• Is testosterone replacement therapy FDA-approved?
• Is compounded testosterone FDA-approved?
• Prescription requirements
• How much does TRT cost?
• Does insurance cover testosterone replacement therapy (TRT)?
• What should I ask a provider before starting testosterone replacement therapy?
• What are the alternatives to TRT?
• Frequently asked questions
• Providers who list testosterone therapy
• References
• Page information

Overview

Guidelines from the American Urological Association and the Endocrine Society say low testosterone should be confirmed by blood tests and come with symptoms or signs before testosterone replacement therapy (TRT) is considered.[1][2] TRT products include gels applied to the skin and injections given into a muscle or under the skin.[3][4]

How testosterone works

The AndroGel 1.62% label describes primary hypogonadism as testicular failure, and hypogonadotropic hypogonadism as failure of the hypothalamus or pituitary gland to make gonadotropins.[3] Knowing how testosterone acts in the body does not show that treatment helps a patient. Whether it does is tested in clinical trials.

Why people use it

Guidelines say low testosterone should be confirmed with at least two early-morning blood tests and should come with symptoms or signs before treatment is considered. The American Urological Association (AUA) guideline (published 2018, validity confirmed 2024) says the diagnosis should be made only after two total testosterone measurements taken on separate occasions, both in the early morning.[1] The AUA guideline uses a total testosterone level below 300 ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone. The AUA guideline says testosterone deficiency is diagnosed only when low total testosterone levels are combined with symptoms or signs.

The Endocrine Society guideline (2018) recommends diagnosing hypogonadism only in men with symptoms and signs of testosterone deficiency and unequivocally and consistently low testosterone levels.[2] The Endocrine Society guideline (2018) recommends against routine screening of men in the general population for low testosterone.

The AndroGel 1.62% and Xyosted labels say to confirm the diagnosis by measuring testosterone in the morning on at least two separate days, with both results below the normal range.[3][4]

Sources: AndroGel 1.62% gel prescribing information, Revised 07/2025; Xyosted injection prescribing information, Revised 07/2025.

Both guidelines were published in 2018, before the TRAVERSE heart trial reported its results in 2023.

Does testosterone therapy work, and what do the trials show?

The Testosterone Trials and TRAVERSE found a modest increase in sexual activity and desire and small or mixed effects on energy and mood. In TRAVERSE, which enrolled men aged 45 to 80 with confirmed low testosterone and heart disease or high heart risk, clinical fractures occurred in 3.50% of men on testosterone gel and 2.46% on placebo (hazard ratio 1.43; 95% CI 1.04 to 1.97), and the authors concluded that testosterone did not lower the fracture rate.[5] In a TRAVERSE sub-study of men with prediabetes, testosterone gel did not significantly reduce progression to diabetes.[6]

Potential benefits

Evidence levels in this table follow our grading key: Established means consistent results from randomized trials or a review of them; Emerging means some controlled human evidence that falls short of that, such as a single trial, mixed results, or trials funded wholly or partly by the drug's maker; Evidence against means trials tested the benefit on their main outcome and did not find it. Of the trials in this table, the Testosterone Trials and TRAVERSE gave testosterone as a gel and lasted about one and three years, and T4DM gave injections for two years; the reviews pooled trials of several forms and lengths.

Sexual activity, desire and erections

In the Testosterone Trials, a set of one-year trials in 790 men aged 65 and older with low testosterone and symptoms, funded by the National Institute on Aging with additional funding and study gels from AbbVie, testosterone increased sexual activity, sexual desire and erectile function compared with placebo gel.[7] In a TRAVERSE sub-study of 1,161 men with confirmed low testosterone and low sex drive, men on testosterone gel reported about 0.5 more sexual acts per day than men on placebo at 6 and 12 months, and the effect was maintained at 24 months.[8] Results on erections were mixed: erectile function improved in the Testosterone Trials but not in the TRAVERSE sexual function study.

A 2025 summary of a Cochrane review of randomized trials in men with sexual dysfunction, which covered 43 trials with 11,419 participants, concluded that testosterone likely makes little to no difference to erectile function compared with placebo, a finding it rated as moderate-certainty evidence from 6 trials with 2,016 participants.[9] In those 6 trials the mean difference in the erectile function score was 2.37 points (95% CI 1.67 to 3.08) on a scale from 6 to 30, against a minimal clinically important difference of 5 points listed in the review's summary table.[9]

An independent review of 35 randomized trials (5,601 men), funded by the UK's National Institute for Health and Care Research, found that testosterone improved quality of life and sexual function in almost all patient subgroups.[10]

Energy and mood

In the Testosterone Trials, testosterone had no significant benefit on vitality, measured with a fatigue questionnaire, in the trial designed to test it. In TRAVERSE, men on testosterone reported modest but significantly greater improvements in mood and energy than men on placebo, results that were not the trial's main outcomes.[11] In a randomized trial of a testosterone solution applied to the skin for 12 weeks, whose ClinicalTrials.gov record lists Eli Lilly and Company as the sponsor, 715 men with a testosterone level below 300 ng/dL and low energy, low sex drive or both were randomized, and energy scores among those who started with low energy improved more with testosterone than with placebo (p = 0.02), a difference that did not meet the trial's preset threshold of p below 0.01.[12][13] The Testosterone Trials found slightly better mood and lower severity of depressive symptoms with testosterone. In TRAVERSE, testosterone made no significant difference on any measured outcome in the 49 men with persistent low-grade depression, a group the authors said may have been too small to show one.

Muscle strength, lean mass and physical function

A review of 13 randomized trials in 2,043 men over 60 with low or low-normal testosterone found a small increase in measured muscle strength with testosterone.[14] A review of 59 trials, including some men without low testosterone, found that testosterone reduced fat mass and increased lean mass, which are body measurements rather than health outcomes.[15] In the Testosterone Trials, walking distance did not improve significantly in the trial designed to test physical function, although a difference appeared when men from all three main trials were combined.

Bone density and fractures

In a one-year trial of 211 men aged 65 and older with low testosterone, spine bone density rose 7.5% with testosterone compared with 0.8% with placebo, but bone density is a measurement and not a fracture outcome.[16]

Pooled analyses of randomized trials, which we read as abstracts, reached different conclusions about bone density. A 2006 review of 8 placebo-controlled trials with 365 men found a gain in spine bone density with injected testosterone and no significant effect with testosterone given through the skin.[17] A 2019 review of 7 randomized trials with 800 older men with low testosterone found no significant effect on bone density at the spine or the femoral neck, and a significant one at the total hip and trochanter.[18]

In a TRAVERSE sub-study of 5,204 men aged 45 to 80 with confirmed low testosterone and heart disease or high heart risk, clinical fractures occurred in 3.50% of men on testosterone and 2.46% on placebo (hazard ratio 1.43; 95% CI 1.04 to 1.97).[5] The TRAVERSE fracture study's authors concluded that testosterone did not lower the rate of clinical fractures compared with placebo, and that fractures were numerically more common with testosterone.

Memory and thinking

In a one-year trial of 493 men aged 65 and older with low testosterone and memory complaints, testosterone did not improve memory or other thinking skills compared with placebo.[19] TRAVERSE also found no improvement in thinking skills or sleep quality with testosterone.

Other randomized trials and reviews, which we read mainly as abstracts, gave differing results on thinking skills. TEAAM, a three-year trial funded by AbbVie Pharmaceuticals and others, randomized 308 men aged 60 and older with low or low-normal testosterone to testosterone gel or placebo; thinking skills, which were secondary outcomes, were analysed in the 280 men who had baseline assessments and did not improve.[20] A 2019 review of 23 randomized trials, which included TEAAM and the Testosterone Trials memory trial and in which, according to its authors, none of the trials treated clinically hypogonadal men, found a small overall improvement that was not statistically significant.[21] Smaller trials have reported gains on some tests, including a six-week trial of testosterone injections completed by 25 healthy men aged 50 to 80, and LITROS, a six-month trial that randomized 83 older men with obesity, low testosterone and frailty, 70 of whom completed it, and that put all of them in a lifestyle program.[22][23]

Diabetes

In a TRAVERSE sub-study of 1,175 men with confirmed low testosterone and prediabetes, testosterone did not significantly reduce progression to diabetes compared with placebo.[6] Among the 3,880 men in TRAVERSE who already had diabetes, blood sugar control and diabetes remission were similar with testosterone and placebo. The TRAVERSE diabetes study authors concluded that testosterone alone should not be used to prevent or treat diabetes in men with hypogonadism.

In T4DM, a two-year Australian trial, 1,007 men aged 50 to 74 with a waist of 95 cm or more, a testosterone level of 14.0 nmol/L or lower but no pathological hypogonadism, and impaired glucose tolerance or newly diagnosed type 2 diabetes were enrolled in a lifestyle program and randomly assigned to testosterone undecanoate injections or placebo.[24] At two years, a glucose tolerance test showed type 2 diabetes in 55 of the 443 men with data in the testosterone group (12%) and 87 of the 413 in the placebo group (21%), a relative risk of 0.59 (95% CI 0.43 to 0.80).[24] Hematocrit rose past the trial's safety trigger in 106 of 491 men on testosterone (22%) and 6 of 484 on placebo (1%), and prespecified serious adverse events occurred in 10.9% of men on testosterone and 7.4% on placebo.[24] The trial was funded by the Australian National Health and Medical Research Council, Bayer, Eli Lilly, the University of Adelaide and WW.[24]

T4DM and the TRAVERSE diabetes study tested different things: T4DM gave injections alongside a lifestyle program to men without pathological hypogonadism, and TRAVERSE gave gel to men with confirmed low testosterone, so the two results cannot be combined or set against each other directly.[24][6]

Anemia

Among men with low testosterone and anemia, testosterone corrected anemia more often than placebo: in TRAVERSE, a trial funded by AbbVie and others, anemia was corrected in 45.0% of men on testosterone and 33.9% on placebo at 12 months.[25][26]

Limitations

TRAVERSE and the Testosterone Trials, the main trials on this page, both used a testosterone gel, so their results may not apply equally to injections or other forms. TRAVERSE followed men for about 3 years on average and the Testosterone Trials for 1 year, and the authors of an independent review of earlier trials noted a lack of data on long-term safety.[27] We read most of the trial reports cited on this page as published summaries (abstracts), not full papers.

Most of the individual trials described on this page enrolled men with low or low-normal testosterone. Some studies on this page also included men whose testosterone was not low. The Cochrane review of men with sexual dysfunction assessed testosterone regardless of serum testosterone level, and it downgraded its erectile function result for differences in population that included mixed age under 40 years, baseline testosterone over 12 nmol/L, or both. Other examples include T4DM, which enrolled men with a testosterone level of 14.0 nmol/L or lower but no pathological hypogonadism, a six-week injection trial in healthy men aged 50 to 80, a trial in obese men with severe obstructive sleep apnea who were not selected by testosterone level, and male-contraception studies of healthy men, which measured sperm counts only. A 2019 review of thinking skills reports that none of its trials treated clinically hypogonadal men, and a 2016 review of body composition included some men without low testosterone. The abstracts of the 2006 bone density review, the 2011 review of how soon testosterone effects appear and the 2022 hematocrit review of 29 trials do not say what testosterone levels the men had. A Europe PMC title-and-abstract search run on October 8, 2026 for randomized trials of testosterone in men with normal levels returned records that we did not screen one by one. This page therefore does not show whether testosterone helps men whose levels are normal, beyond what the studies described here measured.

TRAVERSE was funded by AbbVie and others.[28] The Testosterone Trials were funded by a U.S. National Institute on Aging grant and other National Institutes of Health institutes; AbbVie also provided funding and the gels but, according to the authors, did not take part in designing, running or analyzing the trials. The AndroGel 1.62% label reports that about 61% of all men in TRAVERSE stopped their study treatment, and the average time on treatment was about 22 months.

Risks and side effects

Heart attack and stroke

TRAVERSE was a large randomized trial that compared testosterone gel with placebo in 5,204 men aged 45 to 80 who had confirmed low testosterone, symptoms, and heart disease or a high risk of it. In TRAVERSE, 55% of the men already had cardiovascular disease, 69% had diabetes and 93% had high blood pressure.

In TRAVERSE, which was funded by AbbVie and others, heart attacks, strokes and cardiovascular deaths counted together occurred in 7.0% of men on testosterone gel and 7.3% on placebo over about three years of follow-up, which met the trial's test for not being worse than placebo. The same trial found more atrial fibrillation, acute kidney injury and pulmonary embolism in men taking testosterone. A result of not being worse than placebo in one trial does not prove that testosterone carries no heart risk.

An independent review of earlier, shorter randomized trials, funded by the UK's National Institute for Health and Care Research, found cardiovascular or cerebrovascular events in 7.5% of men on testosterone and 7.2% on placebo in the 13 trials that reported them. The authors of that review concluded that their findings did not support a link between testosterone and cardiovascular events in the short to medium term, and noted a lack of data on long-term safety.

In a 2022 independent review funded by the UK's National Institute for Health and Care Research, 4 earlier randomized trials reported blood clots in the veins, which were rare and not clearly more common with testosterone (5 of 1,037 men, 0.5%, compared with 7 of 1,034 on placebo, 0.7%), a result to read alongside the TRAVERSE finding on pulmonary embolism.[27] In a one-year trial that enrolled 170 men aged 65 and older with low testosterone, 138 of whom completed it and were analysed, testosterone gel increased the volume of non-calcified plaque in the heart arteries on CT scans compared with placebo; no major cardiovascular events occurred in either group.[29] Plaque volume is an imaging measurement, not a count of heart attacks or strokes, and the plaque trial was small.

Blood pressure

The AndroGel 1.62% label reports that in a 24-hour blood pressure study, average systolic blood pressure rose by 1.9 mm Hg and diastolic by 1.3 mm Hg after 16 weeks of treatment. The Xyosted label reports that in its 24-hour blood pressure study, average systolic blood pressure rose by 3.9 mm Hg and diastolic by 1.5 mm Hg after 12 weeks, and 10% of patients started or changed blood pressure medicine during the one-year study. The two labels' blood pressure studies used different products, designs and lengths, so their results cannot be compared with each other. In TRAVERSE, systolic blood pressure at 36 months had risen by 1.0 mm Hg with testosterone and fallen by 0.5 mm Hg with placebo, a difference of 1.5 mm Hg.

Prostate

In a TRAVERSE sub-study that excluded men at higher prostate risk, high-grade prostate cancer was found in 5 of 2,596 men on testosterone (0.19%) and 3 of 2,602 on placebo (0.12%), a difference that was not statistically significant.[30] The TRAVERSE prostate sub-study excluded men with a PSA above 3.0 ng/mL or severe urinary symptoms. In the same sub-study, rates of any prostate cancer, urinary retention, prostate procedures and biopsies did not differ significantly between testosterone and placebo. PSA levels rose more with testosterone than with placebo in the TRAVERSE prostate sub-study.

Blood tests and monitoring

Testosterone raised hematocrit, the red blood cell level, with each of the five forms pooled in a review of 29 placebo-controlled trials, so clinicians check blood counts before and during treatment.[31] In a review of 29 placebo-controlled trials, average hematocrit rose by 1.4% to 4.3% compared with placebo, depending on the form of testosterone.[31]

The published summary of the 2022 review of 29 placebo-controlled trials does not list nasal gel among the forms it pooled.[31] In an open-label randomized trial at the University of Miami in men with a testosterone level below 350 ng/dL, in which 81 men were randomized and 54 completed treatment, hematocrit did not change significantly over 4 months with nasal testosterone gel and rose from 42.7% to 46.6% with testosterone cypionate injections.[32]

A 2022 independent review of earlier randomized trials found that hematocrit rose by an average of 3.15% more with testosterone than with placebo in the 15 trials that measured it, and that more men on testosterone had high hematocrit in the 7 trials that reported it (30 of 1,079 men, 2.8%, compared with 5 of 993 on placebo, 0.5%).[27]

The AndroGel 1.62% label advises checking hematocrit before starting treatment, again 3 to 6 months after starting, and then once a year. The AndroGel 1.62% label says that if hematocrit becomes elevated, treatment should be stopped until it falls to an acceptable level. The Xyosted label advises checking hematocrit about every 3 months during treatment, and stopping Xyosted permanently if hematocrit becomes elevated again after a restart. The AndroGel 1.62% label also advises checking testosterone levels, PSA, hemoglobin, hematocrit, liver tests and blood lipids periodically. The AUA guideline says clinicians should measure hemoglobin and hematocrit before offering testosterone and inform patients about the increased risk of polycythemia, a high red blood cell level.

In a health-records study of men on TRT, men who developed a high red blood cell level (polycythemia) had more heart events and blood clots in the first year than matched men on TRT who did not (5.15% vs 3.87%), an association that does not prove cause.[33]

Side effects and other risks

The AndroGel 1.62% label's warnings include higher red blood cell levels, blood clots in the veins, higher blood pressure, abuse, lower sperm production, liver problems, fluid retention, breast enlargement, sleep apnea, changes in blood lipids and high blood calcium. Side effect rates on different testosterone labels come from different trials with different designs, so they cannot be compared directly.

All five rows of Table 4 of the AndroGel 1.62% prescribing information (Revised 07/2025): side effects in a 182-day double-blind trial of 234 men on AndroGel 1.62% and 40 on placebo. Side effect rates on different testosterone labels come from different trials with different designs, so they cannot be compared directly.

In the AndroGel 1.62% label's 182-day trial, a rise in PSA was the most common side effect, reported in 11.1% of men on the gel and none on placebo. The Xyosted label reports that a PSA rise led 4.6% of patients to stop treatment in its trial.

The Xyosted label reports that hematocrit rose by an average of 3.8% at 6 months and 5.4% at 1 year, and that "hematocrit increased" was reported as a side effect by 14.0% of patients in its one-year study. The AndroGel 1.62% label says testosterone may worsen sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung disease. In a randomized trial of 67 obese men with severe obstructive sleep apnea, testosterone injections given with a diet program mildly worsened breathing during sleep at 7 weeks, but not at 18 weeks.[34]

The AndroGel 1.62% label's boxed warning says virilization has been reported in children who were secondarily exposed to testosterone gel, and that children should avoid contact with unwashed or unclothed application sites.

The prescribing information for AndroGel 1.62% gel, AndroGel 1% gel, Testim gel and Vogelxo gel carries a boxed warning about secondary exposure to testosterone.

The prescribing information for Aveed injection carries a boxed warning about serious pulmonary oil microembolism (POME) reactions and anaphylaxis, and Aveed is available only through a restricted program called the Aveed REMS Program.

The AndroGel 1.62% label notes that serious heart, liver and mental health problems have been reported with anabolic steroid abuse at high doses, and that drug dependence has not been documented in people using testosterone at labeled doses for its labeled uses. The Xyosted label reports that 4 of 283 patients (1.4%) in its trials had depression or suicidality, including 2 suicide attempts, one of which was completed.

Sources: AndroGel 1.62% gel prescribing information, Revised 07/2025; AndroGel 1% gel prescribing information, Revised 07/2025; Testim gel prescribing information, Revised 07/2025; Vogelxo gel prescribing information, Revised 07/2025; Aveed injection prescribing information, Revised 07/2025.

Contraindication considerations

The AndroGel 1.62% label (Revised 07/2025) says the gel should not be used by men with breast cancer or known or suspected prostate cancer, or by women who are pregnant. The Xyosted label also lists known hypersensitivity to Xyosted or its ingredients, including sesame oil.

The prescribing information for Aveed injection, Azmiro injection, Jatenzo capsules, Kyzatrex capsules, Tlando capsules, Testim gel, Vogelxo gel and AndroGel 1% gel each lists breast cancer, known or suspected prostate cancer, and pregnancy as contraindications.[35][36][37][38][39][40][41][42] The Aveed injection, Azmiro injection, Jatenzo capsules, Kyzatrex capsules and Tlando capsules prescribing information also list hypersensitivity to the product or its ingredients.[35][36][37][38][39] The Natesto nasal gel prescribing information lists breast cancer, known or suspected prostate cancer, and pregnancy or breast-feeding as contraindications, and says it is not recommended for people with chronic nasal conditions or altered nasal anatomy.[43] The prescribing information for each of these nine products also says testosterone is not recommended for men with uncontrolled high blood pressure.

Contraindications differ between testosterone products, so the label for the specific product applies. The Endocrine Society guideline (2018) recommends against testosterone therapy in men with breast or prostate cancer, a prostate nodule, a PSA above 4 ng/mL (or above 3 ng/mL with high prostate cancer risk, without further evaluation), elevated hematocrit, untreated severe sleep apnea, severe urinary symptoms, uncontrolled heart failure, a heart attack or stroke within the last 6 months, or a tendency to form blood clots.[2]

The Endocrine Society guideline says clinicians should not give testosterone to men whose hematocrit is above the laboratory's upper limit of normal before treatment without first discussing the higher risk of erythrocytosis and the need for close monitoring.[2] The AUA guideline says testosterone should not be started for 3 to 6 months after a cardiovascular event.[1] Guideline statements about heart risk written before 2023 predate the TRAVERSE results.

Sources: prescribing information, Section 2 (Dosage and Administration), for AndroGel 1% gel prescribing information, Revised 07/2025; AndroGel 1.62% gel prescribing information, Revised 07/2025; Testim gel prescribing information, Revised 07/2025; Vogelxo gel prescribing information, Revised 07/2025; Natesto nasal gel prescribing information, Revised 07/2025; Aveed injection prescribing information, Revised 07/2025; Azmiro injection prescribing information, Revised 07/2025; Xyosted injection prescribing information, Revised 07/2025; Jatenzo capsules prescribing information, Revised 09/2025; Kyzatrex capsules prescribing information, Revised 07/2025; Tlando capsules prescribing information, Revised 07/2025.

If you have severe symptoms, call 911 or seek emergency care. Report side effects to FDA MedWatch.

Administration methods

How often testosterone is given depends on the product, and each product's prescribing information sets its own schedule. Among the labels we read, the schedules run from three times a day for Natesto nasal gel to every 10 weeks for Aveed injection.[43][35]

Label dosing schedules by product

The AndroGel 1.62% gel, AndroGel 1% gel and Testim gel prescribing information each say the product's application site and dose are not substitutable with other topical testosterone products.[3][42][40] The Kyzatrex capsules and Tlando capsules prescribing information each say the product is not substitutable with other oral testosterone undecanoate products.[38][39] The Azmiro injection prescribing information notes that injectable testosterone products may have different doses, strengths or administration instructions and are not substitutable on a milligram-per-milligram basis.[36]

Schedules in this table are summarized from Section 2 (Dosage and Administration) of each product's prescribing information. The Sources line under the table links each label.

This table leaves out Depo-Testosterone injection, and it does not cover every testosterone product.

Not reported means the label's dosing section does not say when to check the first level.

Dose schedules on this page summarize the prescribing information for the testosterone products named and are not instructions to follow.

A prescriber sets and adjusts the dose.

Sources: prescribing information, Section 2 (Dosage and Administration), for AndroGel 1% gel prescribing information, Revised 07/2025; AndroGel 1.62% gel prescribing information, Revised 07/2025; Testim gel prescribing information, Revised 07/2025; Vogelxo gel prescribing information, Revised 07/2025; Natesto nasal gel prescribing information, Revised 07/2025; Aveed injection prescribing information, Revised 07/2025; Azmiro injection prescribing information, Revised 07/2025; Xyosted injection prescribing information, Revised 07/2025; Jatenzo capsules prescribing information, Revised 09/2025; Kyzatrex capsules prescribing information, Revised 07/2025; Tlando capsules prescribing information, Revised 07/2025.

The AUA guideline says clinicians should not prescribe alkylated oral testosterone, noting that methyl testosterone use is associated with liver toxicity.[1]

What should I expect at a TRT appointment or session?

The Aveed injection prescribing information says to observe patients in the healthcare setting for 30 minutes after each injection, in order to provide appropriate medical treatment in the event of serious pulmonary oil microembolism (POME) reactions or anaphylaxis.[35] The American Urological Association guideline, in its section on intramuscular testosterone undecanoate, says that patients should be monitored for 30 minutes in a healthcare setting after injection to monitor for POME or anaphylactic-type symptoms.[1] We searched the prescribing information for the other ten products in the dosing table for the word "minute" on October 8, 2026 and found no length given for a testosterone appointment.

Sources: Aveed injection prescribing information, Revised 07/2025.

Guidelines say low testosterone should be confirmed with at least two early-morning blood tests and should come with symptoms or signs before treatment is considered. The American Urological Association (AUA) guideline (published 2018, validity confirmed 2024) says the diagnosis should be made only after two total testosterone measurements taken on separate occasions, both in the early morning.[1] The Endocrine Society guideline (2018) says total testosterone should be measured on two separate mornings while fasting, because levels vary through the day and from day to day and can be lowered by food.[2] The Endocrine Society guideline notes that about 30% of men whose first testosterone result is low have a normal result when the test is repeated.[2] The Endocrine Society guideline advises against testing for low testosterone during or soon after an acute illness, or during short-term use of medicines such as opioids that lower testosterone.[2] Both guidelines recommend measuring luteinizing hormone after a low testosterone result, and the Endocrine Society guideline also names follicle-stimulating hormone, to help tell whether the cause lies in the testes or in the pituitary gland or hypothalamus.[2][1]

A blood test result is not a treatment decision. A licensed clinician reviews the results and decides whether testosterone treatment may be appropriate.

The AUA guideline times the first follow-up testosterone test by form: 2 to 4 weeks after starting a gel or nasal testosterone, no earlier than three to four dosing cycles into cypionate or enanthate injections, and halfway between the first two 10-week injections of long-acting undecanoate.[1]

Timings as each guideline states them; a product's prescribing information may set different intervals.

The Endocrine Society guideline recommends seeing a urologist if, during the first 12 months, a confirmed PSA rises more than 1.4 ng/mL above the starting level, a confirmed PSA is above 4.0 ng/mL, or a prostate exam finds an abnormality.[2]

The Endocrine Society guideline (2018) says to stop testosterone if hematocrit rises above 54% until it falls to a safe level, to check for low oxygen levels and sleep apnea, and then to restart at a lower dose.[2]

The AUA guideline (2018) says that a hematocrit above 50% before treatment should lead clinicians to consider holding testosterone until the cause is investigated, and that a hematocrit of 54% or higher during treatment calls for action such as a lower dose or a pause.[1]

Do not change or stop a prescribed medicine without talking with the clinician who prescribed it.

Booking an appointment or getting a blood test does not guarantee a prescription.

How long until results?

The trials on this page report results at set time points; the Testosterone Trials, for example, assessed men at 3, 6, 9 and 12 months.[7]

In the Testosterone Trials of 790 men aged 65 and older with low testosterone and symptoms, the gain in sexual activity with testosterone gel was reported as an average across the visits, and the response was somewhat smaller at month 12, a change over time that was not statistically significant.[7] The Testosterone Trials were funded by a U.S. National Institute on Aging grant and other National Institutes of Health institutes; AbbVie also provided funding and the gels but, according to the authors, did not take part in designing, running or analyzing the trials. In a TRAVERSE sub-study of 1,161 men with confirmed low testosterone and low sex drive, the gain in sexual activity with testosterone gel was present at 6 and 12 months and was maintained at 24 months.[8] TRAVERSE was funded by AbbVie and others.

A 2011 review of earlier studies, whose first author was affiliated with Bayer Pharma AG, estimated that effects on sexual interest appear after about 3 weeks, effects on depressive mood after 3 to 6 weeks, and changes in erections may take up to 6 months.[44] That review describes its method only as a summary of literature data, it is not a trial, and it came before the large trials on this page, so its timings are approximate.

The AUA guideline says clinicians should discuss stopping testosterone 3 to 6 months after starting in men whose testosterone levels have returned to normal but whose symptoms or signs have not improved.[1]

Eight of the eleven labels in the dosing table on this page give a time for the first blood-level check, from 7 days to about 6 weeks after starting, and the other three give none. A testosterone level in the normal range does not by itself mean symptoms have improved.

We have not reviewed evidence on how symptoms change after testosterone is stopped.

We did not search specifically for studies of when men first notice effects, so this section gives the time points trials measured and is not a promised timeline.

Is testosterone replacement therapy FDA-approved?

Testosterone products including AndroGel, Xyosted and Aveed are FDA-approved for testosterone replacement therapy in males with conditions associated with a deficiency or absence of endogenous testosterone, such as primary or hypogonadotropic hypogonadism (as of November 1, 2026).

The FDA status table lists each testosterone product whose label we reviewed, with its route and the uses in its prescribing information.

Is compounded testosterone FDA-approved?

Compounded testosterone is a different product from the testosterone products listed in the FDA status table.

Compounded testosterone, including compounded creams and pellets, is not FDA-approved. FDA states: 'Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.' As of FDA's list updated March 21, 2025, testosterone, testosterone cypionate, testosterone enanthate and testosterone propionate are on FDA's list of substances under evaluation for use by outsourcing facilities (503B Category 1), and this listing is not an FDA approval of any compounded product.

Prescription requirements

Each testosterone product in the FDA status table is available only with a prescription (as of November 1, 2026).

Testosterone is a Schedule III controlled substance under federal law (21 CFR 1308.13). Prescribing and dispensing follow additional federal and state rules.

Completing an intake form or making a payment does not guarantee a prescription.

Whether a product is appropriate for a specific person is decided by a licensed clinician using that product's prescribing information.

Regulatory status checked November 1, 2026. Sources: www.accessdata.fda.gov/…/022309s022lbl.pdf; www.accessdata.fda.gov/…/209863s020lbl.pdf; www.accessdata.fda.gov/…/022219s021lbl.pdf; www.accessdata.fda.gov/…/085635s028lbl.pdf; www.fda.gov/…/fda-issues-class-wide-labeling-changes-testosterone-products; www.fda.gov/…/download; www.ecfr.gov/…/title-21.xml; www.fda.gov/…/compounding-and-fda-questions-and-answers; www.fda.gov/…/testosterone-information

How much does TRT cost?

We do not list prices for testosterone therapy on this page yet. Each provider sets its own prices.

What a provider charges can depend on the product and how it is given, how often it is given, which visits and blood tests are included, and whether insurance applies.

Ask each provider what its price includes, such as visits, blood tests, the medication and any supplies, and whether it is charged per visit, per month or per dose.

Compounded testosterone is not FDA-approved. See FDA's statement.

To find providers, go to Providers who list testosterone therapy.

Does insurance cover testosterone replacement therapy (TRT)?

Coverage varies by plan and can depend on the reason it is prescribed. Confirm coverage, and any prior authorization, with your insurer.

The Medicare Coverage Database page for one local coverage determination on testosterone, L39086 from the contractor Palmetto GBA, lists no related national coverage determination (checked September 30, 2026).[45]

Palmetto GBA, a Medicare contractor, lists coverage conditions for testosterone in its local coverage determination L39086, titled Treatment of Males with Low Testosterone, for the area it serves (checked September 30, 2026). To establish a diagnosis of primary hypogonadism, it expects at least 2 separate fasting testosterone levels, taken on 2 different days and drawn before 10 AM. It also lists PSA testing and a digital prostate exam within the 12 months before prescribing, and a hematocrit evaluation before prescribing, each with ongoing monitoring throughout therapy.[45] Local coverage determination L39086 on the CMS Medicare Coverage Database

UnitedHealthcare's Commercial Medical Benefit Drug Policy titled Testosterone Replacement or Supplementation Therapy (policy 2026D0076J, effective January 1, 2026, checked September 30, 2026) applies to the testosterone products it lists. One of the alternative ways it lists to meet its criteria is two pre-treatment early morning serum total testosterone levels, taken at separate times, below 300 ng/dL or below the lab's reference range. The policy limits authorization to no more than 12 months.[46] UnitedHealthcare policy 2026D0076J

We have not reviewed insurer rules for testosterone gels, nasal gel or capsules, or any Medicare Part D or Medicaid policy.

These are two examples, one from UnitedHealthcare and one from a Medicare contractor. Other insurers and plans set their own rules.

Questions to ask your insurer include whether the product your clinician prescribes is covered, whether prior authorization is needed, and whether the blood tests your clinician orders are covered.

What should I ask a provider before starting testosterone replacement therapy?

These questions draw on the American Urological Association and Endocrine Society guidelines and on product prescribing information. They are prompts for a conversation with a licensed clinician, and they do not show whether testosterone replacement therapy is appropriate for you.

1. Was my low testosterone confirmed with at least two early-morning blood tests on different days?
2. When will my testosterone level first be checked after I start, and at what time relative to my dose?
3. Which blood tests, including hematocrit and PSA, will be checked before and during testosterone treatment, and how often?
4. How often will my hematocrit be checked, and what result would lead to a lower dose or a pause in treatment?
5. If my testosterone level is back in range but my symptoms have not improved after 3 to 6 months, will we talk about stopping?
6. How could testosterone treatment affect my fertility if I may want children?
7. If I may want children, should I have a semen analysis first, and which options besides testosterone are used when men want to keep their fertility?
8. Which testosterone product would I use, and what warnings does its label carry?

What are the alternatives to TRT?

In a conditional recommendation with evidence level Grade B, the AUA guideline says all men with low testosterone should be counseled about lifestyle changes such as losing weight and being more physically active, which it says have the potential to raise testosterone levels or ease symptoms.[1] The Endocrine Society guideline (2018) notes that many men with secondary hypogonadism have causes that may be reversible or treatable, such as obesity, opioid use or other illness, and that these may be managed without testosterone treatment.[2]

Do not change or stop a prescribed medicine without talking with the clinician who prescribed it.

Which approach fits a specific person is decided with a licensed clinician.

Providers who list testosterone therapy

Compounded testosterone is not FDA-approved. See FDA's statement.

You can connect with a licensed provider to ask about an evaluation.

Find a Provider · Connect With a Licensed Provider

A licensed clinician decides whether treatment is appropriate. A prescription is not guaranteed.