UK puberty blockers clinical trial paused over age limit concerns

In Brief

UK clinical trial on puberty blockers paused after regulator suggests raising minimum age to 14.

Key Facts

• A UK clinical trial investigating puberty blockers for children has been paused.
• The Medicines and Healthcare products Regulatory Agency (MHRA) advised raising the minimum participant age to 14.
• MHRA cited concerns about unquantified risks of long-term biological harms from the treatment.
• Discussions between MHRA and the trial sponsor, King’s College London, are scheduled to address wellbeing concerns.
• The trial's recruitment process will be delayed pending resolution of these regulatory concerns.

What Happened

The UK clinical trial studying puberty blockers for children was paused after the MHRA raised concerns about the minimum participant age. The regulator recommended increasing the minimum age to 14 due to potential long-term biological risks. King’s College London, the trial sponsor, will engage with MHRA to discuss these issues before recruitment can continue.

Why It Matters

The pause highlights regulatory scrutiny over the safety and ethical considerations of puberty blocker treatments in young people. Raising the minimum age could affect the study’s timeline and the availability of data on younger participants. The outcome of discussions may influence future clinical research and treatment guidelines for gender dysphoria in children.