New clinical trial on puberty blockers to start after UK ban

Details of a new UK clinical trial to assess the risks and benefits of puberty-blocking drugs in gender-questioning children have been announced.

This follows the ban of these gender treatment drugs last year after a major review raised concerns about a lack of clinical evidence on their safety for under-18s.

Researchers at King’s College London say the trial will involve around 220 children under 16 going through puberty and will examine the impact of drugs on their physical, social and emotional well-being.

Some doctors and activists question whether the trial 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 who attend services for gender issues “tell us they don’t know what to do; they look at the information that is out there and they don’t know what is best for them.”

But he said the study did not expect a “one-size-fits-all finding.”

“We’re looking a lot at the balance between possibly the benefits to mental health and quality of life, and any potential risks or harms.”

He added that this would include monitoring people’s physical health and would also be the first study to look at the impact on brain development.

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

They were used to treat some young people with gender incongruence (when someone’s gender identity does not match the sex they were registered as at birth) or gender dysphoria, when it causes them significant distress.

As a result of uncertainty over the safety of the medicines, highlighted by the Cass review into gender care, led by paediatrician Dr Hilary Cass, doctors can now only offer the treatment to under-18s as part of a research study.

Last year, the government imposed an indefinite UK-wide ban on medicines being prescribed privately or by the NHS to children and young people who question their gender identity.

The new clinical trial, called Pathway, will involve children who currently access gender services and have a diagnosis of gender incongruence.

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

A team of specialist NHS doctors must have a full view of the young person’s wellbeing before deciding whether they believe they are suitable for treatment.

The young person will also need to demonstrate sufficient understanding of the potential impact of taking puberty blockers to give consent, and their parents or legal guardians will need to agree. They will be provided with continuous psychological support.

To explore the impact of the drugs, the researchers plan to start treatment in one group immediately and in another group 12 months later. Children in these groups will be chosen at random.

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

The trial will look at issues such as bone density, brain development and mental health and wellbeing over time.

The research team said the trial had received ethical approval and was 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 involving 3,000 children will investigate different types of support and their effectiveness.

The trial over puberty blockers has already proven controversial and campaigners have threatened legal action.

Keira Bell, who took the Tavistock gender clinic to court in 2020 after she was given puberty blockers and cross-sex hormones as a teenager, said the trial should be stopped immediately. If not, she says she and another activist will launch judicial review proceedings in the High Court.

He said it was “disgusting” that children were being given drugs when they had already been banned because they were “unsafe”.

In their case, the High Court ruled that it was “unlikely that children under 16 would be able to give informed consent” to puberty blockers, but this was later overturned by the Court of Appeal, which ruled that doctors can judge whether young people can give consent to the treatment.

Some doctors from the Sex and Gender Clinical Advisory Network, which campaigns for rigorous science and better treatment options for people questioning their gender, have also questioned whether the trial can be carried out ethically.

Study leader Professor Simonoff said: “We know there are ongoing societal debates about gender transition, but this research focuses solely on informing and improving healthcare by better understanding how to support the physical and mental health of gender-incongruent young people.”

A spokesperson for the Stonewall charity, which campaigns for LGBTQ+ rights, said all young people should have access to the best healthcare, guided by evidence.

“We urge government and policymakers to invest in providing excellent healthcare to trans young people and ensure the voices of trans young people and their families are at the centre.”