The National Health Service in England has initiated two significant clinical studies to examine the impact of puberty blockers on young people experiencing gender incongruence. This development comes directly following the landmark Cass review, which highlighted concerning gaps in evidence regarding these treatments.
The Research Programme Details
Researchers have unveiled the Pathways programme, consisting of two separate studies that will collectively involve hundreds of participants. The first, called Pathways Trial, plans to recruit approximately 226 young people over the coming three years. Participants will be aged between 10-11 years for biological females and 11-12 for biological males at the youngest, though researchers note most will likely be older due to rigorous selection processes. The upper age limit for participation is set at 15 years and 11 months.
In this randomised controlled trial, participants will be divided into two groups: one receiving puberty blockers immediately, and another beginning treatment after a 12-month delay. All participants will receive comprehensive care and support throughout the study period. Their health, wellbeing, and development will be carefully monitored for 24 months, with individual clinical reviews determining ongoing care needs at the trial's conclusion.
Brain Development and Cognitive Research
The second study, Pathways Connect, will involve approximately 150 participants from the main trial alongside about 100 young people with gender incongruence who aren't receiving puberty blockers. This component will use MRI brain imaging to examine neurological development, analysing results alongside performance in cognitive tasks and tests.
The research team emphasises that results from both studies won't be available for at least four years. This timeline reflects the comprehensive nature of the investigation and the importance of gathering robust, long-term data.
Context and Controversy
This research initiative follows NHS England's decision last year to stop routinely prescribing puberty blockers to children with gender dysphoria, restricting their use to research settings. The move came after Dr Hilary Cass's independent review found insufficient evidence about the effects of puberty suppression on psychological wellbeing, cognitive development, and fertility.
However, the trial design has drawn criticism from advocacy groups. Chay Brown, health director at TransActual, described the research as coercive in nature, expressing concern that some participants would experience distressing pubertal changes during the waiting period. Brown noted this trial represents the only pathway to accessing puberty blockers through the NHS for the foreseeable future.
Professor Emily Simonoff, chief investigator of the studies from King's College London, defended the approach, suggesting that puberty blockers should perhaps have only ever been available through clinical trials when first introduced. She emphasised the importance of establishing a robust evidence base for these medical interventions.
The outcomes of these studies are eagerly anticipated by medical professionals, policymakers, and families alike, as they promise to provide much-needed clarity on the effects of puberty blockers on young people's development and wellbeing.
