Puberty blockers trial paused over concerns from medicines watchdog

"In a letter published on the government website on Friday, the MHRA expressed concern over the current age limit for participants in the trial. "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," it reads."

"The clinical trial, called Pathways, was set to involve children who are distressed about their gender and currently accessing gender services. It would examine the impact of the drugs on their physical, social and emotional wellbeing. But the MHRA has suggested the minimum age limit of those taking part should be increased to 14, and that there should be more detailed monitoring of bone density and a more rigorous consent process for participants."

"The Medicines and Healthcare Products Regulatory Agency (MHRA) is set to hold talks with King's College London, whose researchers are leading the trial, next week to address concerns, the government said. Details of the trial, which would involve more than 220 children aged between about 11 and 15, were announced in November after getting approval from the MHRA and Health Research Authority. An MHRA spokesperson said the "safety and wellbeing" of participants - yet to be recruited - was "paramount"."

A clinical trial testing puberty-blocking drugs in children questioning their gender has been paused after safety concerns from the Medicines and Healthcare Products Regulatory Agency (MHRA). The trial, Pathways, planned to recruit more than 220 children roughly aged 11 to 15 to study physical, social and emotional outcomes. The MHRA has raised concerns about the lower age limit and recommended starting eligibility at 14, improved bone density monitoring, and a more rigorous consent process. Talks between the MHRA and King's College London researchers are scheduled to address the identified safety and wellbeing issues.

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