ResearchPart 7 of 7 in Landmark TRT clinical studies

The Lancet Seminar: Who Should Not Take Testosterone

Basaria's Lancet seminar on male hypogonadism is best remembered for its contraindications — prostate and breast cancer, uncontrolled heart failure, severe urinary symptoms, and erythrocytosis. The list has aged better than most of the decade around it.

By
Keen Clinician Team
Published
August 25, 2026
Last reviewed
August 25, 2026
Read time
3 min
Sources
2 cited

In 2014 the Lancet published a seminar on male hypogonadism by Shalender Basaria.[1] It arrived in the middle of the most contested decade testosterone has had, four years after Basaria's own trial had been stopped early for cardiovascular events.[2]

Much of what the seminar says about diagnosis has since been stated more precisely elsewhere. One section has not needed revising: the list of men who should not be given testosterone at all.

The exclusion list

The seminar names the contraindications to testosterone-replacement therapy as:[1]

  • Prostate cancer
  • Breast cancer
  • Uncontrolled congestive heart failure
  • Severe lower-urinary-tract symptoms
  • Erythrocytosis

Two are hormone-sensitive cancers. Heart failure and severe urinary symptoms are both conditions testosterone can make worse rather than cause. Erythrocytosis is the odd one out: an already-high red cell count is the therapy's most common adverse effect, showing up before the therapy does.

That last one is the reason hematocrit sits on every monitoring panel, and why a raised baseline is a reason to stop rather than a number to note. The mechanism is covered in polycythemia and hematocrit.

Why the list outlasted its decade

The years after this seminar rewrote several things about testosterone. The cardiovascular question was reopened, argued over, and eventually settled by TRAVERSE and the FDA labelling changes that followed. Estimates of who benefits narrowed.

The contraindications did not move, because they were never conclusions from a single trial. They follow from what the hormone does — stimulate hormone-sensitive tissue, retain fluid, raise red cell mass — rather than from any one study's endpoint. Evidence that revises a risk estimate does not revise a mechanism.

What the seminar gets right about diagnosis

The seminar defines hypogonadism as failure to produce physiological testosterone concentrations, normal sperm, or both.[1] That "or both" is the part most summaries drop.

Hypogonadism is not only a testosterone problem. A man can have adequate testosterone and impaired spermatogenesis, and the distinction changes what treatment is appropriate — because testosterone therapy suppresses sperm production rather than supporting it, which is set out in testosterone and fertility.

The seminar also notes that presentation varies with the age at which androgen deficiency began, whether the defect is in testosterone or in sperm, genetic factors, and any history of previous androgen therapy.[1] The same laboratory number means different things in a man who has been on testosterone before.

Diagnosis, as here, rests on signs and symptoms together with low morning testosterone on multiple occasions.[1] That requirement has been in the literature for over a decade and is still the one most often skipped.

Choosing a formulation

On delivery, the seminar declines to name a winner. Several therapies are approved, and selection should follow patient preference, cost, availability, and the properties of the specific formulation.[1]

This is the same position the Endocrine Society guideline took four years later, and it remains the honest answer. A formulation that suits the man is the one he will keep using.

What has been superseded

Read as current guidance, the seminar shows its age. Its prevalence figures and diagnostic thresholds have been overtaken by more recent work, including the 2026 JAMA review, which specifies the confirmation threshold and the conditions under which free testosterone is required.

Read as an account of who should be excluded, it holds.

Bottom line

Most of the testosterone conversation is about who should be treated. This seminar is one of the clearer statements of who should not be, and that list has survived the trials, the warnings and the reversals of the decade that followed it.

Any assessment that does not ask about prostate and breast cancer, heart failure, urinary symptoms and baseline hematocrit is not a complete assessment.

References

2 sources
  1. Basaria S. Male hypogonadism. Lancet. 2014;383(9924):1250–1263. doi:10.1016/S0140-6736(13)61126-5 · PMID 24119423
  2. Basaria S, Coviello AD, Travison TG, et al. Adverse Events Associated with Testosterone Administration. N Engl J Med. 2010;363(2):109–122. doi:10.1056/NEJMoa1000485 · PMID 20592293

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