UK puberty blocker trial paused after regulator raises safety concerns

theguardian.com

A UK clinical trial for puberty blockers has been paused due to safety concerns raised by the medicines regulator. The trial will not recruit participants until these issues are resolved. The Medicines and Healthcare products Regulatory Agency (MHRA) warned of "unquantified risk" of long-term biological harms, recommending a minimum participant age of 14. Discussions are ongoing between the MHRA and the trial sponsor, King's College London. This pause follows the Cass review's findings of a weak evidence base for puberty blockers in children with gender dysphoria, leading NHS England to restrict their use to research settings.


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