An investigator-led trial that is investigating puberty blockers in children and young people has been paused following concerns raised by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
The Phase III PATHWAYS trial (ISRCTN12491684), run by King’s College London, investigating gonadotropin-releasing hormone analogues (GnRHa), including leuprolide acetate and triptorelin, in children and young people with gender incongruence, has stopped recruiting while discussions take place.
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A Department of Health and Social Care spokesperson said: “We have always been clear about the red lines regarding this trial – ensuring the safety and well-being of the children and young people involved and always being led by the clinical evidence. The MHRA has now raised new concerns – directly related to the well-being of children and young people – and scientific dialogue will now follow with the trial sponsor.
“As the evidence is now being interrogated by clinicians, preparations for the trial have been paused while the MHRA and clinical leaders work through these concerns. This trial will only be allowed to go ahead if the expert scientific and clinical evidence and advice conclude it is both safe and necessary. The safety and well-being of children and young people have always been the driving consideration in every decision we have made regarding this trial and always will be.”
The study was set to enrol approximately 226 children between 11 and 15 years of age; however, the MHRA has suggested the minimum age of enrolment should rise to 14 years of age.
The study involves children who are distressed about their gender and currently accessing gender services, examining the impact of the puberty blockers on their physical, social and emotional wellbeing.
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By GlobalDataIn the UK, puberty blockers for people under-18 were banned in 2024 after the Cass Review. The Commission of Human Medicines (CHM) provided an independent report on the continued prescribing of puberty blockers in children to the government, concluding there is “currently an unacceptable safety risk”.
At the time of the ban, TransActual, a UK organisation that provides information about trans rights and health matters, said: “Banning medicines with no evidence of serious harm, only for trans people, using powers designed for contaminated and life-threatening drugs, is discrimination plain and simple.”
