British researchers have announced two studies examining the effects of puberty blockers on gender nonconforming young people after an expert opinion said gender medicine “built on shaky foundations”.
Puberty blockers were originally used to treat early puberty in children, but also used for other purposes in children with gender dysphoria or incongruity.
However, review Box office 2024 The NHS Gender Identity Services for Children and Young People found “insufficient/inconsistent evidence on the effects of puberty suppression on psychological or psychosocial well-being, cognitive development, cardio-metabolic risk or fertility.”
The National Health Service in England subsequently announced that children with gender dysphoria would be no longer receive puberty blockers as routine practice, with their use limited to research institutions.
Now researchers have announced two new studies as part of the wider Pathways program to study the effects of such drugs on young people in specialist treatment. National Health Service gender services for children and youth.
The Pathways Trial is a clinical trial that will enroll approximately 226 young people over the next three years. The youngest participants are expected to be between 10 and 11 years old for biological females and 11 and 12 years old for biological males (though the team notes that the rigorous selection process means participants will likely be older), and the upper age limit for joining the study is 15 years and 11 months.
Participants will be randomized to start taking puberty blockers immediately or start taking the drugs after a year's delay, along with a wider package of care and support.
In all cases, their health, well-being and development will be closely monitored for 24 months, with each participant assessed individually and clinically at the end of the study to assess their ongoing care needs – which the team says may include continued use of puberty blockers.
The participants' results will also be compared with those of another group of gender nonconforming young people who are not receiving puberty blockers.
The second study, called Pathways Connect, will involve about 150 Pathways study participants, as well as about 100 gender nonconforming youth not receiving puberty blockers, undergoing brain MRIs, with the results compared to performance on cognitive tasks and tests.
The team says it will be at least four years before the results of the research are known.
Chey Brown, health director of the advocacy group TransActual, raised ethical concerns about the trial, calling it “coercive in nature.”
“This is, and will be for a long time, the only way young people can access puberty blockers through the NHS,” he said.
“Worse, the fact that this is a randomized controlled trial, which means some young people will have to wait another year for puberty suppression, is not a neutral act. Those in this group will experience unpleasant changes at puberty that are not present in the other group.
“While we are pleased that some young people will be able to access the help they need without being criminalized, we fear this is overall bad news for young trans people in the UK.”
Emily Simonov, professor of child and adolescent psychiatry at King's College London and principal investigator of the new studies, said new drugs often only become available through clinical trials.
“It could be argued that puberty suppression should never have been available to young people outside of clinical trials about 10 or 15 years ago, and the most ethical decision would have been to conduct the study at that point,” she said.
