Puberty blockers trial can start recruiting children after judge rejects legal challenge

A significant clinical trial investigating the effects of puberty-delaying drugs on children exploring their gender identity has received clearance to proceed following a High Court ruling that dismissed a legal challenge brought by campaign groups. The Pathways trial, conducted by King’s College London (KCL), aims to recruit over 220 participants aged 11 to 16 starting from August 1.

This research was initiated to evaluate the potential advantages and risks associated with puberty blockers, especially in light of a major review that highlighted the lack of robust evidence supporting their use in young people. The trial is designed to fill critical gaps in understanding the outcomes of such treatments. Opponents of the trial had argued that existing safety measures were insufficient and voiced concerns about the unknown long-term physical and psychological consequences for the children involved.

Justice Chamberlain, presiding over the case, declined the judicial review request, stating that the claims raised by the campaigners were unlikely to succeed. He emphasized that each child participating in the trial will have undergone thorough evaluations over an extended period by specialist clinicians. These experts will have concluded that the child stands to gain a reasonable clinical benefit from the intervention. Responding to the court’s decision, a spokesperson for KCL affirmed that safeguarding the wellbeing of young participants remains the utmost priority of the study.

Despite the ruling, campaign groups, including parents of gender-questioning children, expressed their disappointment, warning that the trial carries broad implications worldwide and involves critical ethical considerations. The debate follows a landmark 2024 review of gender services authored by Baroness Hilary Cass, which led to a government ban on prescribing puberty blockers in gender care for children outside clinical trials. Children already receiving these drugs were allowed to continue treatment, but new prescriptions require enrollment in controlled research studies like Pathways.

NHS England commissioned the trial to gather scientific data addressing the risks and benefits of puberty blockers. KCL researchers aim to recruit 226 young people with a diagnosis of “gender incongruence”—where an individual’s gender identity does not align with their sex assigned at birth—who are already engaged with specialist gender services. The clinical trial involves rigorous medical and psychological evaluations and requires participants and their families to fully understand the implications of involvement.

The study will explore how these drugs impact factors such as bone density, brain development, fertility, and mental health. Dr. Matt Westmore, Chief Executive of the Health Research Authority, which is party to the legal proceedings, highlighted the robust safeguards in place. He stated, “High profile studies like this will always attract extra scrutiny and we welcome the opportunity to assure the public of the safeguards put in place. The checks that we carry out, alongside the independent ethics review process, ensure the interests of participants are put first, and that the research is safe and ethical.”

Legal challenges to the trial emerged in late 2025, involving groups like the Bayswater Support Group, representing concerned parents skeptical of medical treatments for their gender-questioning children. Other plaintiffs included psychotherapist James Esses and Keira Bell, a public figure who underwent puberty suppression at 16 but later detransitioned and spoke against such interventions. Bell commented on the court’s decision, calling it “a tragedy” and arguing, “The medical profession and morality do not always walk hand-in-hand. If they did, this trial would be out of the question.”

Critics like the Bayswater Group raised issues about the study’s scope and questioned whether adequate protections for minors had been implemented given the weak evidence on the effectiveness of puberty blockers. Initially planned to begin recruitment in January 2026, the trial faced delays due to the legal dispute. Furthermore, safety warnings from the Medicines and Healthcare products Regulatory Agency (MHRA) influenced the trial’s age criteria. After safety consultations, it was agreed that girls aged 11 and above and boys aged 12 and older could participate, with the strengthened safeguards aimed at ensuring participant safety

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