Study set to delay recruitment after warning participants should be a minimum of 14 years old
A clinical trial into puberty blockers for children has been paused after the medicines regulator warned it should have a minimum age limit of 14 because of the “unquantified risk” of “long-term biological harms”.
Discussions between the Medicines and Healthcare products Regulatory Agency (MHRA) and the trial sponsor, King’s College London, will begin next week to discuss the wellbeing concerns, the Department of Health and Social Care (DHSC) said on Friday evening.
The Pathways clinical trial will not begin to recruit until the issues have been resolved, it added.
The trial was announced after a recommendation by the Cass review into children’s gender care, which concluded that the quality of research claiming to show the benefits of such medication for youngsters with gender dysphoria was “poor”.
