Testosterone therapy monitoring: what gets checked and why

Testosterone therapy monitoring means regular blood work once treatment starts. The European Medicines Agency, in the testosterone review concluded by the CMDh on 8 January 2015, requires regular monitoring of hemoglobin, hematocrit, liver function and blood lipids, plus caution in pre-existing hypertension. The European Association of Urology 2026 guideline schedules checks at 3, 6 and 12 months, then annually.

Key takeaways

• The European Medicines Agency’s testosterone referral, concluded 8 January 2015, requires regular monitoring of hemoglobin, hematocrit, liver function and lipids, and caution in pre-existing hypertension.
• The European Association of Urology guidelines on male hypogonadism, 2026 edition, set monitoring at 3, 6 and 12 months and then annually, and list a hematocrit of 54 percent or above among the contraindications.
• In the T4DM trial, published in Lancet Diabetes and Endocrinology in 2021, hematocrit above 54 percent occurred in 106 of 491 men (22 percent) on testosterone versus 6 of 484 (1 percent) on placebo.
• The US Food and Drug Administration stated on 28 February 2025 that ambulatory blood pressure monitoring studies confirmed an increase in blood pressure with all testosterone products, class-wide.
• TRAVERSE, published in the New England Journal of Medicine in June 2023, found a higher incidence of atrial fibrillation, acute kidney injury and pulmonary embolism in the testosterone group.

Who does this page apply to?

This page applies to men with confirmed low testosterone. Health Canada’s product monograph for oral testosterone undecanoate, authorized 12 December 2025, requires deficiency to be clearly demonstrated by clinical features and confirmed by two separate validated biochemical assays of morning testosterone, and states the product should not be used to treat non-specific symptoms suggestive of hypogonadism if testosterone deficiency has not been demonstrated. What testing your own case needs is a decision for your doctor or nurse practitioner.

It does not apply to men whose testosterone is normal. The European Medicines Agency states that testosterone medicines are licensed in the EU to treat men with abnormally low levels of the hormone and are not approved for use in healthy older men. The European Association of Urology 2026 guideline sets the diagnostic threshold at a total testosterone of 12 nmol/L (3.5 ng/mL), confirmed on two separate occasions. For the diagnostic steps, see how low testosterone is diagnosed in Canada.

What does a testosterone therapy monitoring schedule look like?

The schedule most often cited comes from the European Association of Urology guidelines on male hypogonadism, 2026 edition: monitoring at 3, 6 and 12 months after starting, then annually. The European Medicines Agency referral sets the content of that monitoring rather than its timing, naming hemoglobin, hematocrit, liver function and blood lipid profile, and adding caution in men with pre-existing hypertension.

Canadian labels add warnings without setting a schedule. Health Canada’s product monograph for testosterone cypionate injection, revised 12 July 2018, advises cardiovascular risk assessment before starting, and the monograph for oral testosterone undecanoate, authorized 12 December 2025, carries warnings on blood pressure increases and venous thromboembolism.

Why is hematocrit the number that comes up most often?

Because it is the measurement most likely to change treatment. Hematocrit is the share of blood volume made up of red cells, and testosterone raises it. The European Association of Urology 2026 guideline lists a hematocrit of 54 percent or above among its absolute contraindications. The same guideline gives relative contraindications as well: an IPSS above 19, a baseline hematocrit of 48 to 50 percent, and a family history of venous thromboembolism. A hematocrit in that band is a reason for closer attention rather than an automatic bar.

The clearest numbers come from the T4DM trial, published in Lancet Diabetes and Endocrinology in 2021, which randomized 1,007 men aged 50 to 74. Hematocrit above 54 percent occurred in 106 of 491 men (22 percent) on testosterone versus 6 of 484 (1 percent) on placebo. The authors describe increases in hematocrit as potentially treatment limiting.

The Testosterone Trials anemia analysis, published by Roy and colleagues in JAMA Internal Medicine in 2017 in 788 men aged 65 and older, reads in both directions. In men with unexplained anemia, hemoglobin rose by 1.0 g/dL or more in 54 percent on testosterone versus 15 percent on placebo. The same paper reports that 6 men who were not anemic at baseline reached a hemoglobin above 17.5 g/dL, so the mechanism that corrects anemia in one man pushes another past the top of the range.

Does testosterone therapy raise blood pressure?

Yes, and a regulator has now said so class-wide. The US Food and Drug Administration announced class-wide labelling changes for testosterone products on 28 February 2025: the cardiovascular boxed warning language was removed; the TRAVERSE results and product-specific ambulatory blood pressure monitoring data were added to all testosterone labels; and a new blood pressure warning was added for products that lacked one. The FDA stated that those ambulatory monitoring studies confirmed an increase in blood pressure with use of all testosterone products, class-wide.

The size of the increase depends on the measurement. The US prescribing information for injectable testosterone enanthate, revised July 2025, reports that in ambulatory blood pressure monitoring, systolic and diastolic blood pressure increased by an average of 3.9 and 1.5 mm Hg at 12 weeks. The same label reports the TRAVERSE figure of a mean systolic increase of 1.0 mm Hg from baseline to 36 months. That label’s boxed warning is now titled for blood pressure increases, and the cardiovascular outcomes boxed warning is gone. A regulator that removed one warning and added another is saying where it thinks the residual risk sits, as covered in what the TRAVERSE trial found and what it changed.

Figures used on this page

How is the prostate monitored on testosterone therapy?

Prostate monitoring is built around PSA and the prostate examination, with thresholds set by guidelines rather than statute. The Endocrine Society clinical practice guideline, published by Bhasin and colleagues in 2018, recommends against starting testosterone in men with a PSA above 4 ng/mL, or above 3 ng/mL in men at increased risk, without urological evaluation first, and in men with a palpable prostate nodule or severe lower urinary tract symptoms.

The European Association of Urology 2026 guideline lists locally advanced or metastatic prostate cancer as a contraindication. The US position moved further: on 18 June 2026, the FDA requested that manufacturers narrow the prostate cancer contraindication to metastatic prostate cancer only, and for benign prostatic hyperplasia requested continued monitoring rather than exclusion. Individual labels update on their own schedule.

What did the TRAVERSE prostate substudy find?

The prostate safety substudy of TRAVERSE, published by Bhasin and colleagues in JAMA Network Open in 2023, analysed 5,204 men with a mean age of 63.3 years over 14,304 person-years, and its findings were favourable. Two exclusions define who the result applies to: men with a PSA above 3.0 ng/mL or an IPSS above 19 were excluded, and at baseline the mean PSA was 0.92 ng/mL and the mean IPSS was 7.1.

Within that screened group, high-grade prostate cancer (Gleason score 4 + 3 or higher) occurred in 5 of 2,596 men (0.19 percent) on testosterone versus 3 of 2,602 (0.12 percent) on placebo, hazard ratio 1.62 (95 percent CI 0.39 to 6.77, P = 0.51), not a significant difference. Any prostate cancer, acute urinary retention, invasive prostate surgical procedures, prostate biopsy, new pharmacologic treatment for lower urinary tract symptoms and change in IPSS also did not differ significantly. One finding bears directly on monitoring: PSA concentrations increased more in testosterone-treated than placebo-treated men.

Canada has made no equivalent change. Health Canada has issued nothing on testosterone since 15 July 2014, and there is no Canadian regulatory response to TRAVERSE or to the US label changes of February 2025 and June 2026. That gap is set out in how Canada’s testosterone rules compare with the US, Europe and Australia.

What about clotting disorders?

Clotting is a specific, named warning rather than a general caution. The EMA and CMDh periodic safety update procedure on testosterone, adopted in September 2016 with implementation required by 28 December 2016, added a clotting disorders warning advising caution in patients with thrombophilia. Health Canada’s product monograph for oral testosterone undecanoate, authorized 12 December 2025, includes venous thromboembolism in its warnings, and TRAVERSE found a higher incidence of pulmonary embolism in the testosterone group.

What did TRAVERSE add to the monitoring list?

TRAVERSE, published in the New England Journal of Medicine in June 2023, enrolled 5,246 men aged 45 to 80 with existing or high cardiovascular risk and two fasting testosterone levels below 300 ng/dL. It found non-inferiority to placebo for the composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, with MACE in 7 percent versus 7.3 percent per the current US label.

The same trial reported a higher incidence of atrial fibrillation, acute kidney injury and pulmonary embolism in the testosterone group. They appear in the US label, which is why a monitoring conversation in 2026 covers rhythm symptoms, kidney function and clot symptoms, not only hematocrit.

Who should not start testosterone therapy?

The Endocrine Society 2018 guideline recommends against starting testosterone in men planning fertility in the near term, men with breast or prostate cancer, a palpable prostate nodule, a PSA above 4 ng/mL (or above 3 ng/mL in men at increased risk) without urological evaluation, elevated hematocrit, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke in the last 6 months, or thrombophilia.

The European Association of Urology 2026 absolute list overlaps, and both documents name fertility, so a man who wants to father children in the near term is one for whom this treatment is not started.

What the evidence does not show

• Monitoring schedules have not themselves been tested head to head. The 3, 6 and 12 month pattern comes from the European Association of Urology 2026 guideline and the test list from the EMA referral concluded in January 2015, not from a trial comparing intervals.
• Bone density gains did not translate into fewer fractures. Snyder 2024 in the New England Journal of Medicine, in 5,204 men followed a median of 3.19 years, found clinical fracture in 91 men (3.50 percent) on testosterone versus 64 (2.46 percent) on placebo, hazard ratio 1.43 (95 percent CI 1.04 to 1.97).
• Blood pressure does not improve on treatment. Corona 2015 in the European Journal of Endocrinology, pooling 59 randomized controlled trials, found no improvement in HDL cholesterol or blood pressure.
• The prostate safety result does not extend to the men who were excluded from it. Bhasin 2023 excluded men with a PSA above 3.0 ng/mL or an IPSS above 19, and PSA rose more on testosterone than on placebo.
• Canada has no post-TRAVERSE regulatory position. Health Canada has issued nothing on testosterone since 15 July 2014, so the US label changes of February 2025 and June 2026 do not apply here.

Frequently asked questions

How often are blood tests done on testosterone therapy?

The European Association of Urology guidelines on male hypogonadism, 2026 edition with a limited update in March 2026, set monitoring at 3, 6 and 12 months after starting treatment, then annually. The European Medicines Agency referral concluded by the CMDh on 8 January 2015 specifies what is measured: hemoglobin, hematocrit, liver function and blood lipid profile. Canadian product monographs carry warnings but do not publish an equivalent schedule.

What hematocrit is considered too high on testosterone therapy?

The European Association of Urology 2026 guideline lists a hematocrit of 54 percent or above among its contraindications to testosterone therapy. In the T4DM trial, published in Lancet Diabetes and Endocrinology in 2021, hematocrit above 54 percent occurred in 106 of 491 men (22 percent) on testosterone versus 6 of 484 (1 percent) on placebo, and the authors described increases in hematocrit as potentially treatment limiting.

Does testosterone therapy raise blood pressure?

The US Food and Drug Administration stated on 28 February 2025 that ambulatory blood pressure monitoring studies confirmed an increase in blood pressure with all testosterone products, class-wide. The US prescribing information for injectable testosterone enanthate, revised July 2025, reports average increases of 3.9 mm Hg systolic and 1.5 mm Hg diastolic at 12 weeks, and a mean systolic increase of 1.0 mm Hg from baseline to 36 months in TRAVERSE.

Is PSA checked before starting testosterone?

The Endocrine Society clinical practice guideline, published by Bhasin and colleagues in 2018, recommends against starting testosterone in men with a PSA above 4 ng/mL, or above 3 ng/mL in men at increased risk, without urological evaluation first. The TRAVERSE prostate substudy, published in JAMA Network Open in 2023, excluded men with a PSA above 3.0 ng/mL or an IPSS above 19, and reported that PSA rose more on testosterone than on placebo.

Can men with a clotting disorder take testosterone?

The EMA and CMDh periodic safety update procedure on testosterone, adopted in September 2016 with implementation by 28 December 2016, added a clotting disorders warning advising caution in patients with thrombophilia. The Endocrine Society 2018 guideline recommends against starting testosterone in men with thrombophilia. TRAVERSE, published in June 2023, found a higher incidence of pulmonary embolism in the testosterone group.

Does testosterone therapy affect fertility?

Both major guideline documents treat fertility as a reason not to start. The Endocrine Society 2018 clinical practice guideline recommends against starting testosterone in men planning fertility in the near term. The European Association of Urology 2026 guideline lists an active desire to father children among its contraindications. Discuss family plans with your doctor or pharmacist before treatment begins rather than after.

Related reading: testosterone, energy and mood.

References

1. Wittert G, et al. 2021. Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial. Lancet Diabetes and Endocrinology. PMID 33338415. DOI: https://doi.org/10.1016/S2213-8587(20)30367-3
2. Roy CN, et al. 2017. Association of Testosterone Levels With Anemia in Older Men: A Controlled Clinical Trial. JAMA Internal Medicine. PMID 28241237. DOI: https://doi.org/10.1001/jamainternmed.2016.9540
3. Lincoff AM, et al. 2023. Cardiovascular Safety of Testosterone-Replacement Therapy. New England Journal of Medicine. PMID 37326322. DOI: https://doi.org/10.1056/NEJMoa2215025
4. Bhasin S, et al. 2018. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. Journal of Clinical Endocrinology and Metabolism 103(5):1715-1744. PMID 29562364. DOI: https://doi.org/10.1210/jc.2018-00229
5. Bhasin S, et al. 2023. Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Network Open. PMID 38150256. DOI: https://doi.org/10.1001/jamanetworkopen.2023.48692
6. Snyder PJ, et al. 2024. Testosterone Treatment and Fractures in Men with Hypogonadism. New England Journal of Medicine. PMID 38231621. DOI: https://doi.org/10.1056/NEJMoa2308836
7. Bhasin S, et al. 2024. Effect of Testosterone Replacement Therapy on Progression to Diabetes. JAMA Internal Medicine. PMID 38315466. DOI: https://doi.org/10.1001/jamainternmed.2023.7862
8. Corona G, et al. 2015. THERAPY OF ENDOCRINE DISEASE: Testosterone supplementation and body composition: results from a meta-analysis study. European Journal of Endocrinology. PMID 26537862. DOI: https://doi.org/10.1530/EJE-15-0262
9. Corona G, et al. 2024. Cardiovascular safety of testosterone replacement therapy in men: an updated systematic review and meta-analysis. Expert Opinion on Drug Safety. PMID 38553429. DOI: https://doi.org/10.1080/14740338.2024.2337741
10. European Medicines Agency. Testosterone-containing medicines referral. PRAC recommendation 9 October 2014, press release 21 November 2014, CMDh position 8 January 2015. https://www.ema.europa.eu/en/medicines/human/referrals/testosterone-containing-medicines
11. European Medicines Agency / CMDh. PSUSA on testosterone, clotting disorders: scientific conclusions and grounds for variation. Adopted September 2016, implementation by 28 December 2016. https://www.ema.europa.eu/en/documents/psusa/testosterone-all-formulations-apart-topical-use-and-testosterone-undecanoate-injection-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementa_en.pdf
12. European Association of Urology. Guidelines on Sexual and Reproductive Health, male hypogonadism chapter. 2026 edition, limited update March 2026. https://uroweb.org/guidelines/sexual-and-reproductive-health/chapter/male-hypogonadism
13. US Food and Drug Administration. FDA issues class-wide labeling changes for testosterone products. 28 February 2025. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-issues-class-wide-labeling-changes-testosterone-products
14. US Food and Drug Administration. Prescribing information, testosterone enanthate injection. Revised July 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209863s020lbl.pdf
15. US Department of Health and Human Services. HHS Announces Requested Updates to Testosterone Therapy Product Labels. 18 June 2026. https://www.hhs.gov/press-room/fda-requests-updates-testosterone-therapy-labeling.html
16. Health Canada. Product Monograph, oral testosterone undecanoate capsules. Authorized 12 December 2025. https://pdf.hres.ca/dpd_pm/00082762.PDF
17. Health Canada. Product Monograph, testosterone cypionate injection. Revised 12 July 2018. https://pdf.hres.ca/dpd_pm/00046306.PDF
18. Health Canada. Information Update, Possible cardiovascular problems associated with testosterone products. 15 July 2014. https://recalls-rappels.canada.ca/en/alert-recall/information-update-possible-cardiovascular-problems-associated-testosterone-products
19. Health Canada. Summary Safety Review, Testosterone Replacement Products, Cardiovascular Risk. 15 July 2014. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00058

This page is educational information, not medical advice. Testosterone is a prescription medication and a controlled substance in Canada. Talk to your doctor or pharmacist about your own situation.