New puberty blockers clinical trial to begin after UK ban

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

It follows a ban on gender treatment drugs last year, after a major study raised concerns about a lack of clinical evidence for their safety in under-18s.

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

Some clinicians 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), said: “We know there are ongoing societal discussions about gender transition, but this research only focuses on informing and improving healthcare by better understanding how to support the physical and mental health of young people with gender incongruence. »

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

They have been used to treat some young people suffering from gender incongruity – when a person’s gender identity does not match the sex recorded at birth – or gender dysphoria, when it causes significant distress.

Due to uncertainty over the safety of the drugs, highlighted by the Cass Gender Care Study, led by pediatrician 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 questioning their gender identity.

The new clinical trial, called Pathway, will involve children who currently access gender services and have been diagnosed with gender incongruity.

They will all have reached puberty, but will be under 16 – and will have to meet strict criteria and undergo an intensive medical and psychological examination before they can start taking puberty blockers.

A team of specialist NHS doctors must have a full picture of the young person’s well-being before deciding whether they are suitable for treatment.

The young person will also need to demonstrate that they understand the potential impact of taking puberty blockers well enough to give consent, and their parent or legal guardian will need to agree. They will benefit from ongoing psychological support.

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

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

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

The research team said the trial had received ethics approval and was expected to begin in January, with five to six children recruited each month. The first results should be available in around four years.

Meanwhile, a larger observational study involving 3,000 children will investigate different types of support and their effectiveness.

The puberty blocker trial has already proved controversial, with campaigners threatening legal action.

Keira Bell, who took the Tavistock Gender Clinic to court in 2020 after she was given puberty blockers and cross-sex hormones when she was a teenager, said the trial should be stopped immediately. If not, she says she and another campaigner will begin judicial review proceedings at the High Court.

She said it was “disgusting” that children were being subjected to drugs when they were already banned because they were “dangerous”.

In his case, the High Court ruled that it was “unlikely that under-16s would 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 give consent to treatment.

Some clinicians at the Sex and Gender Clinical Advisory Network, which advocates for rigorous science and improved treatment options for people with questions about gender, also questioned whether the trial could be conducted ethically.

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

“We urge the government and policymakers to invest in providing excellent health care for trans young people and ensure that the voices of trans young people and their families are at the heart of these efforts.”