PATHWAYS TRIAL
Research type
Research Study
Full title
Puberty Suppression and Transitional Healthcare with Adaptive Youth Services (PATHWAYS). PATHWAYS TRIAL, PATHWAYS CONNECT, and PATHWAYS HORIZON Intensive.
IRAS ID
1011645
Contact name
Emily Simonoff
Contact email
Sponsor organisation
King's College London
Research summary
The PATHWAYS Trial is a UK-wide clinical study investigating the effects of puberty-suppressing medication in children and young people (CYP) who experience gender incongruence. Gender incongruence is when a person’s gender identity does not match the sex they were assigned at birth. This can cause significant emotional distress, particularly during puberty, when the body begins to develop secondary sex characteristics.
The medication being studied is a gonadotropin-releasing hormone analogue (GnRHa), which temporarily pauses puberty. Although this treatment is already used in some countries, there is limited high-quality evidence about its benefits and risks in this context. The PATHWAYS Trial aims to provide robust, independent possible evidence on benefits and harms.
The trial will involve 226 participants under the age of 16 who are eligible for GnRHa. Participants will be randomly assigned to either start treatment immediately or after a one-year delay. The two groups will be compared over two years to assess how the timing of treatment affects quality of life, mental health, physical development, cognitive function, and gender-related distress. Young people will be followed up for the funding period, up to another 2.5 years.
Participants will attend regular clinic visits, complete questionnaires, and undergo health checks, including blood tests and scans. Some will also take part in brain imaging and cognitive assessments through a linked study called PATHWAYS CONNECT. Another related study, PATHWAYS HORIZON-Intensive, will follow a comparison group of young people who are not receiving GnRHa, to help understand the broader effects of different care pathways.
The research is funded by the National Institute for Health and Care Research (NIHR) and NHS England. It is sponsored by King’s College London and South London and Maudsley NHS Foundation Trust. Recruitment will take place through NHS Gender Services for Children and Young People across England.REC name
London - City & East Research Ethics Committee
REC reference
25/LO/0500
Date of REC Opinion
6 Nov 2025
REC opinion
Further Information Favourable Opinion