Clinical trial of delayed puberty blocker to start in England next year

NHS England has admitted that patients will not be recruited for the first clinical trial to investigate the effects of puberty-blocking drugs until early next year, months later than planned.

The study, which will investigate the “potential benefits and harms of puberty-suppressing hormones for children and young people”, was originally due to start later this year.

According to sources, thousands of children and young people in England who are questioning their gender identity could choose to take part in the trial. process is being set up to bring forward evidence on puberty blockers after Dr Hilary Cass published a groundbreaking review into transgender health care in April that said they were an unproven treatment that could also be harmful to people who use them.

The drugs are used to suppress the production of the sex hormones testosterone and oestrogen, as well as the development of breasts and facial hair. Cass’s praised report said the NHS should exercise “extreme caution” before giving them to young people.

The previous Conservative government banned their use, and the Labour successor supported that position. Wes Streeting, the health secretary, warned of the lack of evidence to show they are safe for use in such a vulnerable group of patients.

NHS England’s move to include patients in a study recommended by Cass has sparked fresh controversy over the use of the drugs and how the health service should treat under-18s facing gender inequality.

Naomi Cunningham, chair of gender campaign group Sex Matters, said: “We understand why the NHS and Dr Hilary Cass believe clinical trials of puberty blockers are necessary, but we urge them to reconsider.

“Such trials are ethically unjustifiable given the known risks of permanent damage to fertility, sexual function and general health.”

However, when NHS England announced in March that it would no longer prescribe the drugs, transgender charity Mermaids criticised the move as “deeply disappointing and a further restriction of the support provided to transgender children and young people through the NHS, leaving transgender young people in the lurch”.

The Supreme Court recently ruled that the ban on puberty blockers in England, Scotland and Wales is lawful. The court dismissed a case brought by the advocacy group TransActual and a young person, who could not be named.

In her judgment, Judge Lang said: “The Cass inquiry’s findings about the very substantial risks and very limited benefits associated with the use of puberty blockers, and its recommendation that future prescribing of puberty blockers by the NHS to children and young people should only be in a clinical trial, and not routinely, amounted to strong scientific evidence supporting restrictions on the supply of puberty blockers on the grounds that they were potentially harmful.”

Critics, including the Good Law Project, have claimed that the NHS’s policy of restricting access to puberty blockers in recent years has led to more young people with gender dysphoria taking their own lives. But a recent government-commissioned study rejected that claim.

Going forward, all children and young people referred to what NHS England plans to be eight new regional gender services for under-18s will be informed about the trial and asked if they would like to take part.

These services will replace the gender identity development service that was hosted by the Tavistock and Portman NHS mental health trust in London until its dissolution in late March. Two services are already operational, run by the children’s hospitals Great Ormond Street in London and Alder Hey in Liverpool.