The Medicines and Healthcare products Regulatory Agency (MHRA) has concluded its scientific dialogue with the trial sponsor on the PATHWAYS clinical trial, and a modified protocol has been agreed as meeting the required regulatory standards. In parallel, the Health Research Authority has approved the trial for its ethical standards.
The modified protocol includes strengthened safeguards including the introduction of minimum ages of entry to the trial and more clearly defined discontinuation measures around safety for bone health, cognition, and vaginal bleeding as well as more detailed information for participants on fertility preservation.
As part of the scientific dialogue process, the MHRA sought the advice of independent experts from the Commission on Human Medicines on participant safety and the adequacy of proposed strengthened safeguards.
The modified protocol was also submitted by the sponsor to the relevant Research Ethics Committee, via the Health Research Authority.
The PATHWAYS clinical trial is a UK-wide clinical study investigating the effects of puberty-suppressing medication in children and young people who experience gender incongruence. It aims to provide evidence on how the timing of treatment affects quality of life, mental health, physical development, cognitive function, and gender-related distress.
Recruitment to the PATHWAYS clinical trial is currently not due to commence until 1 August 2026, due to legal proceedings.