New Clinical Trials Approved for Puberty Blockers
Regulators in the United Kingdom have granted ethical approval for the first clinical trials of puberty-blocking drugs in children since a previous ban on routine prescribing. This development marks a significant shift in the approach to gender identity services for young people, following extensive review and reform of the sector. The trials, led by King's College London, aim to build a robust evidence base for the use of these medications.
Context of the Previous Ban and Cass Review
The approval of these trials comes after a period of significant change in UK gender identity services. New prescriptions for puberty blockers for individuals under 18 were made illegal in the UK in 2024, with a government ban becoming permanent in December of that year. This decision was largely influenced by the findings of the four-year independent Cass Review of young people's NHS gender identity services, led by Dr. Hilary Cass. The review concluded that there was 'remarkably weak evidence' regarding the long-term safety and efficacy of puberty blockers. The ban specifically allows for the use of these drugs within the context of clinical trials to gather necessary evidence.
Prior to this, the Gender Identity Development Service (GIDS) at the Tavistock and Portman NHS Foundation Trust, which was the sole provider of gender identity services for children in England, was shut down in Spring 2023. The Cass Review had deemed the single-provider model 'not a safe or viable long-term option,' leading to its replacement by a network of regional centers.
Details of the 'Pathways Trial'
The newly approved research initiative includes two main studies: the 'Pathways Trial' and 'Pathways Connect.' The 'Pathways Trial' is designed to recruit approximately 226 young people under the age of 16 over three years. Participants must have a diagnosis of 'gender incongruence' according to the World Health Organization's ICD-11 manual, have experienced it for more than two years, and have started puberty. Informed consent from both the child and at least one parent or guardian is mandatory.
The trial will randomize participants into two groups: one receiving puberty-suppressing hormones immediately, and the other beginning treatment after a one-year delay. Both groups will also receive non-medical care and will be followed for two years to monitor their physical, social, and emotional well-being. The 'Pathways Connect' study will specifically focus on the impact of puberty suppression on brain health.
Funding and Objectives
The trials are funded by NHS England, with over £10 million allocated for new research into children's gender care. The contract for the puberty blocker trial alone is valued at £10,694,902.24 and is set to run until 2031. The primary objective is to address the existing evidence gaps and provide clearer information on the benefits and risks of puberty blockers, enabling more informed decision-making for young people and their families. Recruitment for the trials is expected to commence soon.
6 Comments
Stan Marsh
Much needed data to inform future policy decisions.
Eric Cartman
The previous ban was a necessary response to the lack of evidence, and funding new trials to gather data makes sense on paper. Yet, questions persist about whether the trial design adequately protects young participants from potential irreversible effects, and if a two-year follow-up is truly sufficient.
Stan Marsh
This is not care, it's a medical experiment.
Kyle Broflovski
While gathering more evidence is undoubtedly important for informed decisions, the ethical implications of conducting trials on children, especially given previous concerns about these drugs, remain a significant worry for many families. It's a delicate balance between research and protection.
Eric Cartman
They're still experimenting on vulnerable kids. Unacceptable.
ZmeeLove
It's positive that the UK is finally investing in robust research to address the 'remarkably weak evidence' highlighted by the Cass Review. However, I'm concerned about the potential for these trials to be perceived as a re-legitimization of a controversial treatment before truly conclusive, long-term data is available.