Oral testosterone: what the modern capsule trials actually show
Oral testosterone in Canada means testosterone undecanoate capsules absorbed through the lymphatics, not the older 17-alpha-alkylated androgens linked to liver injury in case reports. Swerdloff 2020 in the Journal of Clinical Endocrinology and Metabolism, a phase 3 trial in 222 men, found 87 percent reached the eugonadal range and a mean systolic pressure rise of 3 to 5 mm Hg.
Key takeaways
- Swerdloff 2020 in the Journal of Clinical Endocrinology and Metabolism, a phase 3 trial in 222 men, found 87 percent of both the oral and topical groups reached the eugonadal range, with an oral plasma average of 403 plus or minus 128 ng/dL.
- Blood pressure rose in every trial that measured it. White 2021 in the Journal of Cardiovascular Pharmacology and Therapeutics, using ambulatory monitoring in 138 men, found 24-hour, awake and sleep systolic pressure up 3.8, 5.2 and 4.3 mm Hg.
- In White 2021’s top quartile of hematocrit change, a rise of 6 to 14 percent, the systolic increase averaged 8.3 mm Hg against 1.9 to 3.3 mm Hg in the lower three quartiles.
- Nackeeran 2022 in the Journal of Urology, pooling 29 randomized trials in 3,393 men, put the mean hematocrit increase versus placebo for oral testosterone undecanoate at 4.3 percent (95 percent confidence interval 0.7 to 8.0).
- Honig 2022 in the Journal of Sexual Medicine followed 69 men to 24 months and found a mean of 617 plus or minus 427 ng/dL, hematocrit below 48 percent, and no clinically significant liver function changes.
- Canada has Jatenzo in three strengths marketed since 24 April 2026 and a 40 mg undecanoate capsule. Kyzatrex was approved on 30 June and 2 July 2026 and is not yet marketed. The United Kingdom and Australia have none at all.
Who does this evidence apply to?
All of it applies to men with confirmed low testosterone. Health Canada’s product monograph for oral testosterone undecanoate capsules, authorized 12 December 2025, requires deficiency to be clearly demonstrated by clinical features and confirmed by two separate validated biochemical assays of morning testosterone. None of it applies to men whose testosterone is normal. For the diagnostic steps, see how low testosterone is diagnosed in Canada. What testing your own case needs is a decision for your doctor or nurse practitioner.
Why was swallowed testosterone a problem, and what changed?
Testosterone itself is poorly used by the body when swallowed, so the oral androgens of the past were chemically altered to survive the trip. Those older products were 17-alpha-alkylated, and that modification is the one associated with liver injury in the published case literature.
The modern products solve the absorption problem differently. Testosterone undecanoate is absorbed through the lymphatic system and is not 17-alpha-alkylated. That is a chemistry difference, not a marketing distinction, and it is why the old hepatotoxicity reports cannot simply be applied to the current capsules.
What did the trials of modern oral testosterone undecanoate find?
They found that most men reached the normal range, and that blood pressure went up. Swerdloff 2020 in the Journal of Clinical Endocrinology and Metabolism, a randomized active-controlled open-label phase 3 trial in 222 men (166 oral, 56 topical) over 3 to 4 months, found 87 percent of both groups reached a mean average concentration in the eugonadal range, with the oral group averaging 403 plus or minus 128 ng/dL and a mean systolic blood pressure increase of 3 to 5 mm Hg.
A second Swerdloff 2020 paper in Therapeutic Advances in Urology, covering two phase 3 trials, reported efficacy of 84 and 87 percent. Over 365 days lean mass increased 3.2 plus or minus 2.7 kg and fat mass decreased 2.4 plus or minus 3.6 kg (both p less than 0.0001), with bone density gains at hip and spine, more mild gastrointestinal effects, a systolic rise of about 3 to 5 mm Hg, and no association with liver toxicity.
Figures used on this page
| Study | Population | Finding | Reference |
|---|---|---|---|
| Swerdloff 2020, Journal of Clinical Endocrinology and Metabolism | 222 men (166 oral, 56 topical), 3 to 4 months | 87 percent of both groups in the eugonadal range; oral average 403 plus or minus 128 ng/dL; systolic up 3 to 5 mm Hg | PMID 32382745 |
| Swerdloff 2020, Therapeutic Advances in Urology | Two phase 3 trials, 365 days | Efficacy 84 and 87 percent; lean mass up 3.2 plus or minus 2.7 kg, fat down 2.4 plus or minus 3.6 kg; no liver toxicity | PMID 32655691 |
| Honig 2022, Journal of Sexual Medicine | 86 enrolled in extension, 69 completed 24 months | Mean 617 plus or minus 427 ng/dL; systolic up 3 to 6 mm Hg; hematocrit below 48 percent; HDL down 9.8 plus or minus 0.9 mg/dL | PMID 36272969 |
| Bernstein 2024, Therapeutic Advances in Urology | 155 men, 180 days, single arm | 87.8 percent worst case and 96.1 percent of 90-day completers reached eugonadal mean values, average 452 ng/dL; diet had no effect | PMID 38606384 |
Bernstein 2024 in Therapeutic Advances in Urology, a single-arm study in 155 men over 180 days, adds a detail that matters to anyone reading older material on oral androgens: diet had no effect on the proportion reaching eugonadal values.
How does oral testosterone compare with gel?
One randomized comparison exists, and its advantages were nominal. Miner 2024 in Andrology randomized 315 patients 2:1 against a 1.62 percent gel and found 87.4 percent of oral patients reached the target range. It reported nominally significant advantages for the oral product on the SF-36v2 mental health scale (2.91 versus -0.10, p = 0.035) and the mental component summary (3.82 versus 0.55, p = 0.009), with comparable safety endpoints.
Nominal means the analysis was not adjusted for multiplicity, so those two results are not a demonstrated advantage. A separate Canadian point: the comparator gel in that trial, at 1.62 percent, is not sold here, where only 1 percent gels are marketed. See testosterone gel and cream.
What does oral testosterone do to blood pressure?
It raises it, the most consistent safety finding in the oral evidence base. White 2021 in the Journal of Cardiovascular Pharmacology and Therapeutics studied 138 men over 4 months with ambulatory blood pressure monitoring and found 24-hour, awake and sleep systolic pressure rose 3.8, 5.2 and 4.3 mm Hg respectively.
The same study found hematocrit rose 3.2 percent and hemoglobin 0.9 g/dL, and it linked the two effects. In the top quartile of hematocrit change, a rise of 6 to 14 percent, the systolic increase averaged 8.3 mm Hg, against 1.9 to 3.3 mm Hg in the lower three quartiles. That is the most clinically interesting finding here, because the blood pressure effect is evidently not uniform.
The other trials point the same way at different magnitudes: about 3 to 5 mm Hg in both Swerdloff 2020 papers, 3 to 6 mm Hg over two years in Honig 2022 (p less than 0.05), and 1.7 mm Hg on ambulatory monitoring in Bernstein 2024. None reported a reduction. What that means for someone with existing high blood pressure is a question for a doctor or pharmacist.
What happens to hematocrit on oral testosterone?
It rises, by roughly the same amount as other routes, with wide uncertainty. Nackeeran 2022 in the Journal of Urology, a network meta-analysis of 29 placebo-controlled randomized trials in 3,393 men, put the mean hematocrit increase versus placebo at 4.3 percent for oral testosterone undecanoate (95 percent confidence interval 0.7 to 8.0), against 3.0 percent for gel, 4.0 percent for intramuscular enanthate or cypionate, 1.6 percent for intramuscular undecanoate and 1.4 percent for the patch.
The confidence interval for the oral figure is the widest of the five, and the only between-formulation difference that reached significance was short-ester injection against the patch. The authors also wrote that the clinical concern of this increase remains questionable.
Honig 2022 in the Journal of Sexual Medicine, following 69 men to 24 months, reported hematocrit rose slightly but stayed below 48 percent. The route-by-route comparison is set out in hematocrit and testosterone by delivery method.
Are the modern capsules the same as the old oral androgens that damaged livers?
No. The liver evidence concerns 17-alpha-alkylated androgens such as methyltestosterone, and it is case-report level only. No controlled trial established that harm.
Borhan-Manesh 1989 in Archives of Internal Medicine described a 64-year-old man who developed cholestatic jaundice after six months of methyltestosterone, with an alkaline phosphatase normal or only mildly elevated and disproportionate to the hyperbilirubinemia. Mork 1997 in Zeitschrift fur Gastroenterologie described a 55-year-old man with progressive jaundice after 17-alpha-methyltestosterone that resolved on ursodeoxycholic acid. Hartleb 1990 in the American Journal of Gastroenterology described severe jaundice with destructive cholangitis after methyltestosterone.
Three points belong together. These are individual case reports, not a rate or a controlled comparison. The modern capsules are a different chemistry, absorbed through the lymphatics and not 17-alpha-alkylated. And the modern trials report no liver toxicity, with Swerdloff 2020 in Therapeutic Advances in Urology stating it directly and Honig 2022 finding no clinically significant liver function changes over two years, but those trials run to months and years, not decades. Absence of a signal in a two-year extension is not a long-term safety record.
Which oral testosterone products are available in Canada?
Two are marketed and one is approved but not yet available, verified in the Health Canada Drug Product Database on 14 September 2026.
| Brand | Ester and form | Company | DIN | Status |
|---|---|---|---|---|
| Jatenzo | Undecanoate capsule 158 mg | Tolmar | 02563770 | Marketed 24 April 2026 |
| Jatenzo | Undecanoate capsule 198 mg | Tolmar | 02563789 | Marketed 24 April 2026 |
| Jatenzo | Undecanoate capsule 237 mg | Tolmar | 02563797 | Marketed 24 April 2026 |
| Taro-Testosterone | Undecanoate capsule 40 mg | Taro | 02421186 | Marketed |
| Kyzatrex | Undecanoate capsules, three strengths | Hikma | 02562723, 02562731, 02562758 | Approved 30 June and 2 July 2026, not marketed |
Approved is not the same as available. A product with a drug identification number may still be absent from Canadian pharmacies, and Kyzatrex is in that position as of 14 September 2026. Two older oral products are gone: pms-Testosterone 40 mg, DIN 02322498, dormant since 1 August 2025, and Andriol, DIN 00782327, cancelled on 29 January 2018. See which testosterone products are available in Canada.
Do other countries have oral testosterone?
Two of the four countries checked do not. Neither the United Kingdom nor Australia has any oral testosterone product: Restandol Testocaps was discontinued in the United Kingdom on 25 February 2008, and Andriol Testocaps has been cancelled in Australia, both verified on 14 September 2026 in the Electronic Medicines Compendium and the Australian Register of Therapeutic Goods.
The United States has the widest oral choice, with Jatenzo (NDA 206089), Tlando (NDA 208088) and Kyzatrex (NDA 213953, the 150 and 200 mg strengths, the 100 mg discontinued). Oral undecanoate is a North American option rather than a global standard. See testosterone products compared across four countries.
What the evidence does not show
- No decades-long liver safety record for the modern capsules. Honig 2022 followed 69 men to 24 months with no clinically significant liver function changes, and two years is the longest published follow-up here.
- No controlled evidence of hepatotoxicity for the older 17-alpha-alkylated androgens either. Borhan-Manesh 1989, Mork 1997 and Hartleb 1990 are single case reports: they show harm occurred, not how often.
- No demonstrated advantage over gel. The Miner 2024 advantages on SF-36v2 mental health and the mental component summary were nominally significant, meaning not adjusted for multiplicity, and safety endpoints were comparable.
- No reduction in blood pressure in any trial. Swerdloff 2020, White 2021, Honig 2022 and Bernstein 2024 all reported increases, ranging from 1.7 to 6 mm Hg systolic depending on the measure.
- No clear hematocrit advantage over other routes. Nackeeran 2022 gave the oral figure the widest confidence interval of the five formulations, 0.7 to 8.0 percent, with no significant between-formulation difference except short-ester injection against the patch.
- No favourable lipid finding. Honig 2022 reported HDL cholesterol fell 9.8 plus or minus 0.9 mg/dL over two years.
Frequently asked questions
Is oral testosterone available in Canada?
Yes. Jatenzo testosterone undecanoate capsules in three strengths, DINs 02563770, 02563789 and 02563797, have been marketed since 24 April 2026, and Taro-Testosterone undecanoate 40 mg, DIN 02421186, is also marketed. Kyzatrex was approved on 30 June and 2 July 2026 but is not yet marketed, verified in the Drug Product Database on 14 September 2026.
Does oral testosterone damage the liver?
The modern capsules are testosterone undecanoate, absorbed through the lymphatics, and are not 17-alpha-alkylated. Swerdloff 2020 in Therapeutic Advances in Urology reported that oral testosterone undecanoate was not associated with liver toxicity, and Honig 2022 found no clinically significant liver function changes over 24 months. The published hepatotoxicity reports concern a different chemistry and are case-report level.
Does oral testosterone raise blood pressure?
Yes, in every trial that measured it. White 2021 in the Journal of Cardiovascular Pharmacology and Therapeutics, using ambulatory monitoring in 138 men over 4 months, found 24-hour, awake and sleep systolic pressure rose 3.8, 5.2 and 4.3 mm Hg. Bernstein 2024 in Therapeutic Advances in Urology found a smaller ambulatory systolic rise of 1.7 mm Hg (95 percent confidence interval 0.3 to 3.1).
What happens to hematocrit on oral testosterone?
Nackeeran 2022 in the Journal of Urology, a network meta-analysis of 29 randomized trials in 3,393 men, found a mean hematocrit increase versus placebo of 4.3 percent for oral testosterone undecanoate (95 percent confidence interval 0.7 to 8.0). Honig 2022 in the Journal of Sexual Medicine reported hematocrit rose slightly over two years but stayed below 48 percent.
Is oral testosterone better than gel?
No trial has shown that. Miner 2024 in Andrology randomized 315 patients 2:1 against a 1.62 percent gel and found 87.4 percent of oral patients reached range, with nominally significant advantages on SF-36v2 mental health (2.91 versus -0.10, p = 0.035) and the mental component summary (3.82 versus 0.55, p = 0.009). Nominal means not adjusted for multiplicity, and safety endpoints were comparable.
Do the United Kingdom and Australia have oral testosterone?
No. Neither country has any oral testosterone product. Restandol Testocaps was discontinued in the United Kingdom on 25 February 2008 and Andriol Testocaps has been cancelled in Australia, both verified on 14 September 2026. Among the four countries checked, oral testosterone undecanoate is available only in Canada and the United States.
Related reading: testosterone esters explained, what testosterone therapy actually does and what gets monitored on testosterone therapy.
References
- Swerdloff et al. 2020. A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men. Journal of Clinical Endocrinology and Metabolism. PMID 32382745. DOI: https://doi.org/10.1210/clinem/dgaa238
- Swerdloff et al. 2020. Therapeutic Advances in Urology. PMID 32655691. DOI: https://doi.org/10.1177/1756287220937232
- Honig et al. 2022. Two-Year Analysis. The Journal of Sexual Medicine. PMID 36272969. DOI: https://doi.org/10.1016/j.jsxm.2022.09.002
- White et al. 2021. Effects of a Novel Oral Testosterone Undecanoate on Ambulatory Blood Pressure. Journal of Cardiovascular Pharmacology and Therapeutics. PMID 34191621. DOI: https://doi.org/10.1177/10742484211027394
- Bernstein et al. 2024. A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product. Therapeutic Advances in Urology. PMID 38606384. DOI: https://doi.org/10.1177/17562872241241864
- Miner et al. 2024. Andrology. PMID 39252657. DOI: https://doi.org/10.1111/andr.13747
- Nackeeran et al. 2022. The Effect of Route of Testosterone on Changes in Hematocrit: A Systematic Review and Bayesian Network Meta-Analysis of Randomized Trials. The Journal of Urology. PMID 34445892. DOI: https://doi.org/10.1097/JU.0000000000002188
- Borhan-Manesh et al. 1989. Archives of Internal Medicine. PMID 2774790. DOI: https://doi.org/10.1001/archinte.149.9.2127
- Mork et al. 1997. Zeitschrift fur Gastroenterologie. PMID 9487641. No DOI in the PubMed record.
- Hartleb et al. 1990. American Journal of Gastroenterology. PMID 1693810. No DOI in the PubMed record.
- Health Canada. Drug Product Database. Queried 14 September 2026. https://health-products.canada.ca/dpd-bdpp/search/
- Health Canada. Product Monograph, oral testosterone undecanoate capsules. Authorized 12 December 2025. https://pdf.hres.ca/dpd_pm/00082762.PDF
- United States Food and Drug Administration. Drugs@FDA. Queried 14 September 2026. https://www.accessdata.fda.gov/scripts/cder/daf/
- Electronic Medicines Compendium. United Kingdom product listings. Queried 14 September 2026. https://www.medicines.org.uk/emc
- Therapeutic Goods Administration. Australian Register of Therapeutic Goods. Queried 14 September 2026. https://www.tga.gov.au/resources/artg
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.