The minimum age for children to participate in a trial of puberty blockers is now being set to 11, contradicting advice from the Medicines and Healthcare products Regulatory Agency (MHRA).
The Pathways trial, which seeks to assess the use of puberty-blocking drugs on children, was paused in February after the MHRA raised concerns and warned that the age limit should be raised from 10 to 14.
In a letter to King’s College London, which is leading the research, the MHRA said that the trial should “at the very least” be limited to children age 14 or over due to “potentially significant and, as yet, unquantified risk of long-term biological harms.”
