DistantNews
Support us
UK Puberty Blocker Trial Sets Minimum Age of 11 Amid Safety Reviews
🇬🇧 United Kingdom /Health & Science

UK Puberty Blocker Trial Sets Minimum Age of 11 Amid Safety Reviews

From BBC News · () English

Translated from English, summarized and contextualized by DistantNews.

At a glance

News Named sources Ongoing story
  • A UK clinical trial for puberty-blocking drugs will require participants to be at least 11 years old.
  • The trial, paused earlier due to safety concerns, has strengthened safeguards, including the minimum age, following regulatory review.
  • Recruitment is expected to begin in August, but ongoing legal challenges could cause delays.

A clinical trial in the United Kingdom assessing puberty-blocking drugs for gender-questioning children has set a minimum age of 11 for participation. The Pathways Trial, initially paused in February due to safety concerns raised by the Medicines and Healthcare products Regulatory Agency (MHRA), has now strengthened its safeguards, including the age requirement.

a number of safeguards, including participation age, to be strengthened.

— MHRAThe regulator stated that discussions with the research team led to strengthened safeguards.

The MHRA had previously suggested a minimum age of 14, but discussions with the research team have led to the implementation of a minimum age of 11 for "birth-registered" females and 12 for "birth-registered" males. Researchers from King's College London have also agreed not to recruit participants until after August 1 to allow for ongoing legal proceedings related to the trial's safety and ethics.

demonstrating a good understanding of the intervention and its possible benefits and risks

— ResearchersThis is one of the eligibility criteria for young people participating in the trial.

Puberty blockers, also known as puberty suppressing hormones (PSH), are used to delay or prevent puberty. Their use in individuals under 18 was banned in 2024 following a review that found "shaky foundations" in the evidence base for such treatments. The trial requires parental consent, and young people must demonstrate a "good understanding" of the intervention's potential benefits and risks.

always welcome scrutiny

— ResearchersThe researchers commented on the scrutiny of studies involving children and young people.

Researchers state they welcome scrutiny and have enhanced patient information, though they maintain there are no major changes to the trial's design. Clearer guidance on when to stop the drugs, particularly concerning bone density and brain function, will be provided. Information on fertility preservation will also be detailed. Despite these adjustments, campaigners are pursuing legal action, arguing the trial is unethical and that children cannot give fully informed consent.

there are no major changes to the design or conduct

— ResearchersThe researchers stated that the trial's core design remains unchanged.
DistantNews Editorial

Originally published by BBC News in English. Translated, summarized, and contextualized by our editorial team with added local perspective. Read our editorial standards.

More Stories

From Our Blog