landmark Puberty Blocker Trial Set too Begin in UK Following Recent Ban on Routine Use
LONDON – A new clinical trial investigating the long-term effects of puberty blockers for young people experiencing gender incongruence is slated to begin in January, despite recent restrictions on their routine use within the UK’s national Health Service.The trial, dubbed “Pathway,” comes after a landmark High Court ruling in December 2023 significantly limited access to the drugs outside of research settings.
The study will involve children who have already been diagnosed with gender incongruence and have begun to experience puberty, but are under the age of 16. Participants will undergo rigorous medical and psychological screening by a team of specialist NHS doctors to determine suitability. informed consent will be required not only from the young person – demonstrating a clear understanding of the potential impacts of the medication – but also from their parent or legal guardian. Ongoing psychological support will be provided throughout the trial.
Researchers at King’s college London (KCL) will employ a randomized, controlled design, initiating treatment with puberty blockers for one group immediately, and delaying treatment for a second group by 12 months. While there is no set minimum age for participation, researchers note puberty typically begins around age 11 for girls and 12 for boys.
The trial aims to comprehensively assess the effects of puberty blockers on key areas of development, including bone density, brain development, and overall mental health and wellbeing. Approximately five to six children will be recruited each month, with initial results anticipated within four years.
Along with the clinical trial, a parallel observational study involving 3,000 children will examine the effectiveness of various support systems available to young people accessing gender services.
The research has received ethical approval, marking a crucial step forward in gathering evidence-based data on the use of puberty blockers – a treatment that has become increasingly controversial amid concerns about its long-term consequences and the potential for detransition. The findings are expected to inform future clinical guidelines and improve care for young people experiencing gender-related distress.
