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A clinical study investigating the effects and safety of puberty-blocking medications for children experiencing gender dysphoria has been temporarily halted due to concerns raised by the UK’s medicines regulator. The Medicines and Healthcare Products Regulatory Agency (MHRA) plans to meet with researchers at King’s College London, who are leading the study, to discuss these issues in detail. The pause was confirmed by government officials.
This trial, known as Pathways, aims to involve over 220 participants aged approximately 11 to 15 years, all of whom are currently receiving gender-related healthcare and experiencing distress related to their gender identity. Its goal is to assess how puberty blockers impact various aspects of their physical, emotional, and social wellbeing. Approval for the trial was given last November by both the MHRA and the Health Research Authority, but the study will not proceed with recruitment until outstanding concerns are addressed.
The MHRA specifically raised questions about the appropriateness of the lower age limit, suggesting it should be raised from 11 to 14 years. They also recommended enhanced monitoring of bone density for participants and a more stringent consent process to ensure young people fully understand the treatment’s potential long-term biological risks. According to an official letter made public by the government, the agency emphasized that “potentially significant and, as yet, unquantified risk of long-term biological harms is present” for younger participants, and therefore, a more cautious stepwise approach starting at age 14 is advised.
In response to the MHRA’s concerns, a spokesperson for the Department of Health and Social Care (DHSC) stated that no participants will be enrolled until the regulator’s worries are resolved through discussions with the clinical team. The DHSC reiterated their commitment to safeguarding the health and wellbeing of children involved in the trial, emphasizing that the study will only proceed if expert clinical advice confirms that it is safe and necessary. King’s College London underscored its commitment to prioritizing the health of young people experiencing gender incongruence and highlighted the importance of scientific rigor and ongoing dialogue in conducting a complex trial such as Pathways.
However, the trial has faced criticism from some medical professionals and campaigners who question its necessity and ethics. Legal challenges have been mounted against the MHRA, the government, and others involved, arguing that children may not be capable of fully informed consent, especially regarding treatments that could impact future fertility. These concerns were echoed in a 2024 review by Dr. Hilary Cass, which described the evidence base for gender-related treatments as operating on “shaky foundations,” prompting restrictions on the use of puberty blockers in under-18s earlier this year
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