Puberty Blockers Trial Paused: MHRA Cites Safety Concerns for Under-14s

by Chief Editor

Puberty Blockers Trial Paused: What Does This Mean for Young People and Gender Care?

A clinical trial investigating the use of puberty blockers for children experiencing gender dysphoria has been paused by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The move, announced on February 20, 2026, stems from safety concerns regarding potential “long-term biological harms” and the age of participants. The trial, known as Pathways, was designed to gather crucial evidence in a field marked by a “weak evidence base,” as highlighted by the 2024 Cass review.

The MHRA’s Concerns and the Age Limit

The MHRA has requested that the minimum age for participation in the Pathways trial be raised from 10-12 to 14. This decision reflects concerns about the potential risks associated with administering puberty blockers to younger individuals, where the long-term effects are not yet fully understood. The agency emphasized the require for a “graded/stepwise approach,” suggesting that future trials could potentially include younger participants depending on the findings of this initial phase.

The Cass Review and the Shift in NHS Practice

The pause in the trial follows the recommendations of Dr. Hilary Cass’s independent review of gender identity services for children and young people. The Cass review found the existing research on puberty blockers to be of “poor” quality and led to a significant shift in NHS England’s approach. Puberty blockers are no longer routinely prescribed, and their use is now largely confined to research settings like the Pathways trial.

What are Puberty Blockers and Why the Controversy?

Puberty blockers, also known as puberty suppressing hormones (PSH), are used to temporarily halt the physical changes of puberty. For young people questioning their gender identity, they can provide time to explore their feelings without undergoing irreversible physical changes. However, concerns have been raised about potential side effects, including impacts on bone density and the unknown long-term consequences of delaying puberty.

The Pathways Trial: Aims and Objectives

The Pathways trial aimed to recruit 226 young people over three years to examine the impact of puberty blockers on their physical, social, and emotional wellbeing. The trial was intended to address the lack of robust evidence surrounding the use of these medications and provide clinicians and families with a stronger foundation for informed decision-making. Recruitment is now on hold pending resolution of the MHRA’s concerns.

Expert Reaction: A Regulatory Process Working as Intended

Professor Sir Jonathan Montgomery, a professor of health care law at University College London, emphasized that the pause demonstrates the regulatory process functioning correctly. He stated that the discussions are focused on strengthening the trial protocol and ensuring the safety of participants, rather than halting the research altogether. “The focus here is on safety, as it should be,” he said.

Future Trends in Gender Care for Young People

The pause in the Pathways trial signals a broader trend towards increased caution and a greater emphasis on rigorous research in the field of gender care for young people. Several key developments are likely to shape the future landscape:

  • Increased Demand for Evidence-Based Care: The Cass review has spurred a demand for more robust evidence to support all aspects of gender care, from psychological support to medical interventions.
  • Regional Variations in Access: Following the lead of New Zealand, which banned new prescriptions of puberty blockers for young transgender people in November 2025, other countries may adopt more restrictive approaches.
  • Focus on Holistic Assessment: Future care models are likely to prioritize comprehensive assessments that consider the psychological, social, and familial factors influencing a young person’s gender identity.
  • Development of Alternative Therapies: Research may explore alternative approaches to supporting young people experiencing gender dysphoria, focusing on psychological interventions and social support.

FAQ

What are puberty blockers? Puberty blockers are medications that temporarily pause the physical changes of puberty.

Why was the Pathways trial paused? The trial was paused due to safety concerns raised by the MHRA regarding the age of participants and potential long-term biological harms.

What was the Cass review? The Cass review was an independent review of gender identity services for children and young people in England, which found the evidence base for puberty blockers to be weak.

Will the Pathways trial continue? The trial is currently paused even as the MHRA and King’s College London address the concerns raised. It may resume with a higher minimum age limit for participants.

Where can I identify more information? You can find more information on the MHRA website and BBC News.

Pro Tip: When discussing gender care, it’s crucial to approach the topic with sensitivity and respect for all perspectives. Focus on the wellbeing of the young person and the importance of evidence-based decision-making.

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