Mary Zwicker, European Correspondent:
The United Kingdom put an end to a clinical trial that would have tested the effects of puberty blockers on children as young as 10-years-old.
On Feb. 20, the National Health Service (NHS) in the U.K. announced the halt of a proposed clinical trial of puberty blockers on minors after the Medicines and Healthcare Products Regulatory Agency (MHRA) voiced concerns over the drugs’ effects on those of such a young age, highlighting various safety concerns and a lack of supporting evidence.
“Since potentially significant and, as yet, unquantified risk of long-term biological harms is present to participants and biological safety has not been definitively demonstrated in this proposed cohort, at the very least, there should be a graded/stepwise approach starting with those aged 14 as the lower limit of eligibility,” the MHRA stated.
Known as the “Pathways” study, the clinical trial was funded by the U.K. government and was to be run by researchers at King’s College London. Formerly set to begin in April this year, the study would have involved a total of 226 children who identified as transgender, with the aim of researching the effects of puberty blockers on children. This Pathway trial came as a follow-up to an April 2024 study, known as the Cass Review, which found there was neither no-quality nor low-quality evidence surrounding the safety of puberty blockers for minors.
In their email asking for the trial’s pause, the MHRA voiced concerns over fertility issues following the use of puberty blockers, and highlighted other risks, such as damage to bones.
“It is widely understood that reduction in gametogenesis will very likely cause infertility in these young people,” the MHRA said. “These are medically consequential effects for a future adult individual that may involve infertility treatment and significant medical interventions.”
“Bone effects: It is recognised that short-term bone effects of triptorelin may sometimes be reversible. However, available data suggests treatment with triptorelin beyond 12 months will result in persistent and potentially permanent bone structural change. The involvement of the patients for 24 months means that patients may demonstrate irreversible harm at the 12-month scan,” they added.
The MHRA’s critiques are supported by numerous other studies which have demonstrated the dangers of puberty blockers on youth, especially when given before puberty. Many such studies were presented in the above-mentioned Cass Review, which highlighted risks such as dangers to brain development, finding that for those who use puberty blockers for more than one year, brain activity is significantly impacted. “Brain maturation may be temporarily or permanently disrupted by the use of puberty blockers, which could have a significant impact on the young person’s ability to make complex risk-laden decisions, as well as having possible longer-term neuropsychological consequences,” the Cass Review stated.
The Cass Review also found that there was no evidence that children on puberty blockers had better body image or resolution of gender dysphoria. Additionally, it found that there was little evidence that there were positive mental health benefits for those on puberty blockers.
In March 2024, the U.K. banned the use of puberty blockers for those under eighteen unless used as part of a clinical trial.
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