UK Regulators approve first trials for puberty-blocking drugs in children since ban

UK regulators have approved the first clinical trials of puberty blockers for children with gender dysphoria since a nationwide ban was imposed last year after the Cass Review found evidence for their use in gender transition “built on shaky foundations”.

Led by King’s College London, the Pathways trial will recruit up to 250 children under 16 in England and Wales who have experienced at least two years of gender dysphoria, have started puberty, and can give informed consent alongside a parent or guardian.

Participants will be randomized to receive either puberty-suppressing drugs plus non-medical care or non-medical care alone, with two-year follow-up. A subset will join Pathways Connect for brain scans and cognitive assessments. "Young people with gender incongruence and their families have told us that they do not have the information that they need to make informed choices about their care,” said deputy chief investigator Dr Michael Absoud. “The new studies launched today will give us more information specifically about puberty suppression and will closely monitor any impact on young people’s development. Despite the current ban, some trial participants may continue treatment if deemed “clinically appropriate”.

The program, funded with £10.7 million via the National Institute for Health and Care Research (NIHR),aims to provide robust evidence for informed care decisions

Results are expected in about four years. The Department of Health and Social Care stated:

“Medical care must always be based on solid evidence, and children's safety must come first.”