UK Approves Revised Pathways Puberty‑Blocker Trial With Age Limits

Overview

• The Medicines and Healthcare products Regulatory Agency and King’s College London agreed a modified Pathways protocol between June 19 and June 22 that adds minimum ages and clearer stop rules so the trial can proceed.
• The protocol sets minimum entry ages of 11 for trans boys and 12 for trans girls and restores the trial’s objective of testing the effect of timing on mental and physical outcomes.
• Researchers at King’s College said no children will be recruited before 1 August while legal challenges proceed and a High Court hearing over the trial’s ethical approval is listed for 27 July.
• The revised eligibility and consent rules require parental consent, more than 13 hours of pre‑enrolment assessments, around 50 forms, and specific monitoring for bone health, cognition, fertility information and criteria for stopping treatment.
• Meanwhile NHS children’s gender clinics carry long waits with about 4,079 children on national lists and the services do not prescribe puberty blockers outside research; campaigners and some politicians oppose the trial while Dr Hilary Cass argues the study is needed to reduce harm.