UK Clinical Trial on Puberty Blockers Paused Amid Safety Concerns
Published 20 February 2026
Highlights
- The UK clinical trial on puberty blockers for children has been paused due to safety concerns raised by the Medicines and Healthcare Products Regulatory Agency (MHRA).
- The MHRA suggests raising the minimum age for trial participants to 14, citing potential long-term biological harms.
- Discussions between the MHRA and King's College London, the trial sponsor, are set to address these concerns before recruitment begins.
- The trial, named Pathways, was initiated following the Cass review, which highlighted a weak evidence base for the benefits of puberty blockers.
- The Department of Health and Social Care emphasizes that the trial will only proceed if deemed safe and necessary by scientific and clinical evidence.
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Rewritten Article
UK Clinical Trial on Puberty Blockers Paused Amid Safety Concerns
A UK clinical trial investigating the effects of puberty blockers on children questioning their gender identity has been temporarily halted following intervention by the Medicines and Healthcare Products Regulatory Agency (MHRA). The trial, known as Pathways, was designed to explore the impact of these drugs on the physical, social, and emotional wellbeing of young participants.
Safety Concerns and Age Limitations
The MHRA has raised concerns about the trial's current age limit, suggesting that participants should be at least 14 years old due to the "unquantified risk" of long-term biological harms. The agency emphasized the need for more detailed monitoring of bone density and a rigorous consent process. Discussions between the MHRA and King's College London, the trial's sponsor, are scheduled to address these issues before any recruitment begins.
Background and Context
The Pathways trial was announced following recommendations from the Cass review, which criticized the existing research on puberty blockers for children with gender dysphoria as inadequate. Dr. Hilary Cass, who led the review, noted the lack of a strong evidence base for the benefits of these medications, despite some clinicians and families advocating for their use.
Official Statements and Future Steps
The Department of Health and Social Care (DHSC) has reiterated its commitment to the safety and wellbeing of children involved in the trial. A spokesperson stated that the trial would only proceed if expert scientific and clinical evidence confirms its safety and necessity. King's College London has also affirmed its dedication to the health of young people with gender incongruence, emphasizing the importance of scientific rigour in the trial's design.
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Scenario Analysis
The pause in the Pathways trial highlights the ongoing debate over the use of puberty blockers in young people questioning their gender identity. If the MHRA's concerns are addressed satisfactorily, the trial could provide valuable insights into the safety and efficacy of these treatments. However, if unresolved, it may lead to further delays or even cancellation, impacting future research and policy decisions in this sensitive area. As discussions continue, the outcome will likely influence both clinical practices and the broader discourse on gender dysphoria treatment for minors.
A UK clinical trial investigating the effects of puberty blockers on children questioning their gender identity has been temporarily halted following intervention by the Medicines and Healthcare Products Regulatory Agency (MHRA). The trial, known as Pathways, was designed to explore the impact of these drugs on the physical, social, and emotional wellbeing of young participants.
Safety Concerns and Age Limitations
The MHRA has raised concerns about the trial's current age limit, suggesting that participants should be at least 14 years old due to the "unquantified risk" of long-term biological harms. The agency emphasized the need for more detailed monitoring of bone density and a rigorous consent process. Discussions between the MHRA and King's College London, the trial's sponsor, are scheduled to address these issues before any recruitment begins.
Background and Context
The Pathways trial was announced following recommendations from the Cass review, which criticized the existing research on puberty blockers for children with gender dysphoria as inadequate. Dr. Hilary Cass, who led the review, noted the lack of a strong evidence base for the benefits of these medications, despite some clinicians and families advocating for their use.
Official Statements and Future Steps
The Department of Health and Social Care (DHSC) has reiterated its commitment to the safety and wellbeing of children involved in the trial. A spokesperson stated that the trial would only proceed if expert scientific and clinical evidence confirms its safety and necessity. King's College London has also affirmed its dedication to the health of young people with gender incongruence, emphasizing the importance of scientific rigour in the trial's design.
What this might mean
The pause in the Pathways trial highlights the ongoing debate over the use of puberty blockers in young people questioning their gender identity. If the MHRA's concerns are addressed satisfactorily, the trial could provide valuable insights into the safety and efficacy of these treatments. However, if unresolved, it may lead to further delays or even cancellation, impacting future research and policy decisions in this sensitive area. As discussions continue, the outcome will likely influence both clinical practices and the broader discourse on gender dysphoria treatment for minors.
