Overview
- The MHRA and King’s College confirmed on Friday that a modified Pathways protocol introduces minimum entry ages of 11 for birth-registered females and 12 for birth-registered males.
- The trial was paused in February after the MHRA warned of potentially significant long-term biological harms, specifically citing risks to fertility and bone density.
- King’s College says it has strengthened patient information but made no major changes to the study design and that no children will be recruited before 1 August because of ongoing legal proceedings.
- A campaign group and two individuals have launched a judicial review challenging the trial’s ethical approvals and regulator decisions, and public figures and some politicians continue to oppose the study on consent and safety grounds.
- The Pathways trial was launched after the 2024 Cass Review found the evidence for puberty blockers in young people to be poor and aims to recruit about 226–250 participants for up to two years to measure mental, physical and cognitive outcomes with fertility‑preservation information provided to families.