UK to Launch Two Clinical Trials on Puberty Blockers for Young People with Gender Incongruence
A pair of new clinical trials are set to explore the impact of puberty blockers on young people in the UK, amid growing concerns over the long-term effects of these medications. The trials, part of a broader "Pathways" program, will recruit approximately 376 young participants, aged between 10 and 15 years old, who identify as non-binary or have gender incongruence.
The first trial, Pathways Trial, will involve an estimated 226 participants who will be randomly assigned to either receive puberty blockers immediately or after a one-year delay. The trial aims to monitor the health, wellbeing, and development of these young individuals for up to two years.
In addition to the primary trial, researchers are also planning another study, Pathways Connect, which will involve approximately 250 participants - including some from the first trial - undergoing MRI brain imaging alongside cognitive tests. This investigation seeks to unravel the neural mechanisms underpinning puberty blockers' effects on cognitive development and psychosocial wellbeing.
Critics of these trials, however, have expressed concerns over their design and potential coercion of young individuals into participating in a randomized controlled trial. Chay Brown, health director for advocacy group TransActual, described the setup as "coercive" and warned that some participants may experience distressing pubertal changes while waiting for access to puberty blockers.
Experts acknowledge that the introduction of new medications often occurs through clinical trials, but also point out that the UK's recent review of NHS gender identity services highlighted a significant knowledge gap regarding the long-term consequences of these treatments. The trial organizers have emphasized their commitment to rigorously monitoring participant outcomes and adjusting care plans accordingly, but critics argue that more caution is required in this area.
The results of these trials are expected to be available within four years, with potential implications for the treatment of young people with gender incongruence in the UK's healthcare system.
A pair of new clinical trials are set to explore the impact of puberty blockers on young people in the UK, amid growing concerns over the long-term effects of these medications. The trials, part of a broader "Pathways" program, will recruit approximately 376 young participants, aged between 10 and 15 years old, who identify as non-binary or have gender incongruence.
The first trial, Pathways Trial, will involve an estimated 226 participants who will be randomly assigned to either receive puberty blockers immediately or after a one-year delay. The trial aims to monitor the health, wellbeing, and development of these young individuals for up to two years.
In addition to the primary trial, researchers are also planning another study, Pathways Connect, which will involve approximately 250 participants - including some from the first trial - undergoing MRI brain imaging alongside cognitive tests. This investigation seeks to unravel the neural mechanisms underpinning puberty blockers' effects on cognitive development and psychosocial wellbeing.
Critics of these trials, however, have expressed concerns over their design and potential coercion of young individuals into participating in a randomized controlled trial. Chay Brown, health director for advocacy group TransActual, described the setup as "coercive" and warned that some participants may experience distressing pubertal changes while waiting for access to puberty blockers.
Experts acknowledge that the introduction of new medications often occurs through clinical trials, but also point out that the UK's recent review of NHS gender identity services highlighted a significant knowledge gap regarding the long-term consequences of these treatments. The trial organizers have emphasized their commitment to rigorously monitoring participant outcomes and adjusting care plans accordingly, but critics argue that more caution is required in this area.
The results of these trials are expected to be available within four years, with potential implications for the treatment of young people with gender incongruence in the UK's healthcare system.