King's College London

PATHWAYS TRIAL is a research study that will explore how puberty suppressing hormones (medicines that pause puberty) impact the physical, social, and emotional wellbeing of young people with gender incongruence.

Right now, there isn’t enough information about the possible benefits or risks that young people with gender incongruence may experience when taking puberty suppressing hormones. PATHWAYS TRIAL aims to help fill this gap in the evidence about what we know.

Why is this important?

Gender incongruence is when someone’s gender doesn’t match the sex they were registered at birth. Puberty can be a difficult time for young people with gender incongruence. This is because their body starts to change in ways that don’t match how they feel inside.

Puberty suppressing hormones may help some young people with gender incongruence explore their gender identity more comfortably without feeling rushed or distressed about their body changing. This might also help them feel more comfortable at school, with friends, and in everyday life.

However, doctors and researchers don’t yet know for sure what the benefits or risks of this treatment are. We don’t know whether improvements in emotions and well-being are due to puberty suppressing hormones or other care that young people receive for gender incongruence. There may be risks to puberty suppressing hormones as they might affect brain and bone development. Again, there isn’t enough research to understand whether these changes happen, how much they change, or if they return to normal after treatment stops.

Because of this uncertainty, a law was introduced in the UK which says that doctors can only offer this treatment to young people with gender incongruence as part of a research study.

PATHWAYS TRIAL is the first randomised controlled trial to explore the effects of puberty suppressing hormones among young people with gender incongruence. The findings will help young people, their families, and doctors make better-informed decisions in the future.

How will the PATHWAYS TRIAL be done?

PATHWAYS TRIAL will use a randomised controlled trial design. This means that everyone taking part will be randomly placed in one of two groups - by chance, like flipping a coin. One group will start the treatment straight away, and the other group will start the treatment after 12 months. No one in the study will decide which group they are in.

This approach helps researchers understand how treatment works, by comparing what happens in both groups. It can show whether starting the treatment earlier is more helpful for young people, or if delaying the treatment might lead to fewer unwanted side effects for example.

Funding

The research is funded by the National Research Collaboration Programme (NRCP), a partnership between NHS England and the National Institute for Health and Care Research (NIHR).

Oversight

The research is led by King’s College London and co-sponsored by King’s College London and the South London and Maudsley NHS Foundation Trust.

The study has been carefully checked by independent scientists who advise the National Institute for Health and Care Research (NIHR). These include independent academic peer reviewers and NIHR funding committee consideration.

It has also been carefully checked by the Medicines and Healthcare products Regulatory Agency and received approval from a Research Ethics Committee.

The research is overseen by two groups of people who are independent from the research team and the funders. A Data Monitoring Committee will check the data and highlight any concerns they have about the quality of the data (such as the amount of missing information) and any concerns about the safety or wellbeing of people taking part.

The Programme Steering Committee will include at least two people with lived experience of being a gender diverse young person, or a parent/caregiver of a gender diverse young person, as well as scientists. The Programme Steering Committee will advise on the study’s progress overall.

Documents

PATHWAYS TRIAL Protocol (PDF)

PATHWAYS TRIAL Easy Read Study Description (PDF)

PATHWAYS HORIZON INTENSIVE (PDF)

PATHWAYS TRIAL & CONNECT FAQs (PDF)