Two UK clinical trials to assess impact of puberty blockers in young people | Medical research
Two studies investigating the effect of puberty blockers in gender non-conforming teenagers have been announced by researchers in the UK after an expert said gender medicine was “gender medicine”. “Built on solid foundations”.
Puberty blockers were originally used to treat early-onset puberty in children, but were also used off-label in children with gender dysphoria or nonconformity.
But, 2024 Cass review A study of NHS gender identity services for children and young people found there was “insufficient/inconsistent evidence regarding the effects of puberty suppression on psychological or psychosocial wellbeing, cognitive development, cardio-metabolic risk or fertility.”
NHS England subsequently announced that children with gender dysphoria would no longer receive puberty blockers as routine practice and that their use would be limited to research settings.
Researchers have now announced two new studies as part of a wider ‘Pathways’ program to investigate the impact of such drugs among young people treated in specialist NHS child and young people’s gender services.
The Pathways Trial is a clinical trial that will enroll an estimated 226 young people over the next three years. The youngest participants are expected to be between 10 and 11 years of age for biological females and 11 to 12 years of age for biological males; However, the team notes that the stringent selection process means participants are likely to be older, with the upper age limit to participate in the study being 15 years and 11 months.
Participants will be randomly selected to start puberty blockers immediately, along with a broader care and support package, or to start taking the drugs after a one-year delay.
In all cases, their health, wellbeing and development will be carefully monitored for 24 months and each participant will be examined individually and clinically at the end of the trial to look at their ongoing care needs; This could include continuing to use puberty blockers, the team said.
The participants’ results will also be compared with results from another group of gender nonconforming teens who were not taking puberty blockers.
The second study, called Pathways Connect, will include about 150 of the Pathways Trial participants, as well as about 100 gender nonconforming teenagers who are not taking puberty blockers, who will undergo MRI brain imaging, and the findings will be analyzed based on results from cognitive tasks and tests.
The team says it will take at least four years before the results of the studies are known.
Chay Brown, health director of advocacy group TransActual, raised ethical concerns about the trial, calling it “inherently coercive.”
“This is the only way for young people to access puberty blockers through the NHS and will be for a long time,” he said.
“Worse still, the fact that this is a randomized controlled trial, meaning some teenagers have to wait an extra year for puberty suppression, is not a neutral act. Those in this group will experience distressing pubertal changes that others in the other group will not experience.”
“While we are pleased that some young people will be able to access the care they need without being exposed to crime, we fear this is bad news overall for young trans people in the UK.”
Emily Simonoff, professor of child and adolescent psychiatry at King’s College London and lead investigator of the new studies, said new drugs are often only available through clinical trials.
“We might have wanted to argue 10 or 15 years ago that puberty suppression should never be offered to young people outside of clinical trials, and that the most ethical thing would be to do a trial at that point,” he said.
