New puberty blockers clinical trial to begin after UK ban

Details of a new UK clinical trial assessing the risks and benefits of puberty blocking drugs in children who are unsure about their gender have been announced.

It follows banning gender-specific drugs last year following a major review, concerns were raised about the lack of clinical evidence of their safety in children under 18 years of age.

Researchers from King's College London say the study will involve around 220 children under 16 years of age going through puberty and will examine the effects of drugs on their physical, social and emotional well-being.

Some doctors and campaigners question whether the research is ethical.

Professor Emily Simonoff, study leader and professor of child and adolescent psychiatry at King's College London (KCL), told BBC Radio 4's Today program that young people and their parents attending gender services “tell us they don't know what to do – they look at the information that's out there and don't know what's best for them.”

But she said the study did not expect a “one size fits all” result.

“We're looking very carefully at the balance between possible benefits for mental health and quality of life and any possible risks or harms.”

She added that this would involve monitoring people's physical health and would also be the first study to examine the effects on brain development.

Puberty blockersalso known as puberty suppressing hormones (PSH), are medications used to delay or prevent puberty.

They have been used to treat some young people with gender incongruity (when someone's gender identity does not match their assigned sex at birth) or with gender dysphoria when it causes significant distress.

As a result of uncertainty regarding drug safety highlighted cash desk review In the field of gender care, led by pediatrician Dr Hilary Cass, doctors can now only offer the treatment to children under 18 as part of a research study.

Last year the government introduced a UK-wide permanent ban about medicines prescribed privately or by the NHS to children and young people who are questioning their gender identity.

The new clinical trial, called Pathway, will enroll children who are currently seeking gender services and diagnosed with gender nonconformity.

They will all reach puberty but will be under 16 years of age and will have to meet strict criteria and undergo intensive medical and psychological assessments before they are allowed to start taking puberty blockers.

The NHS team of specialist doctors must have a full understanding of the young person's condition before deciding whether they are suitable for treatment.

The young person will also have to demonstrate that they understand the potential consequences of taking puberty blockers well enough to give their consent, and their parent or legal guardian will have to give their consent. They will be provided with constant psychological support.

To study the effects of the drugs, the researchers plan to treat one group immediately and the other group after 12 months. Children in these groups will be randomly selected.

KCL researchers said there would be no minimum age for taking the drugs, but puberty usually begins at around 11 for girls and 12 for boys.

The study will look at issues such as bone density, brain development, and mental health and well-being over time.

The research team said the study has received ethical approval and is expected to begin in January, recruiting five to six children each month. The first results should be available in about four years.

Additionally, a larger observational study of 3,000 children will examine different types of support and their effectiveness.

The puberty blocker trial has already sparked controversy, with campaigners threatening legal action.

Keira Bell, who sued the Tavistock gender clinic in 2020 after she was given puberty blockers and cross-sex hormones as a teenager, said the trial should be stopped immediately. If that doesn't happen, she says she and another campaigner will begin judicial review proceedings in the High Court.

She said it was “disgusting” that children were being given drugs when they were already illegal because they were “unsafe”.

In her case High Court rules that children under 16 are 'unlikely to be able to give informed consent' to puberty blockers, but this decision was later overturned by the Court of Appeal, which ruled that doctors can judge whether young people can consent to treatment.

Some doctors with the Sex and Gender Clinical Advisory Network, which advocates for rigorous scientific research and improved treatment options for people with gender questions, also question whether the research can be done ethically.

Study leader Professor Simonov said: “We know there is ongoing debate in society about gender transition, but this research is solely focused on informing and improving healthcare by better understanding how to support the physical and mental health of gender nonconforming young people.”

Dr Hilary Cass said she was “really pleased” that Professor Simonoff and the KCL team were carrying out the research.

She said: “My review found very weak evidence for the benefit of using puberty blockers for children and young people with gender dysphoria. In fact, some children had more negative than positive effects.

“However, given that there are doctors, children and families who passionately believe in the positive effects, the study was the only way to understand this.”

She added: “Although a lot of media attention is focused on the research, they have a much broader research agenda. Monitoring outcomes for young people who do not choose the medical route will be just as important as monitoring those who do.”

A spokesman for LGBTQ+ rights charity Stonewall said all young people should have access to the best evidence-based care.

“We call on the government and policymakers to invest in providing excellent healthcare for trans young people and to ensure that the voices of trans young people and their families are front and center.”