New puberty blockers clinical trial to begin after UK ban

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

Like this: Ban on sex therapy drugs last year Following a major review, concerns were raised about the lack of clinical evidence regarding their safety for under-18s.

Researchers from King’s College London say the trial will involve around 220 teenage children under 16 and examine the impact of the drug on the children’s physical, social and emotional health.

Some clinicians and campaigners question whether the research is ethical.

Study leader and professor of child and adolescent psychiatry at King’s College London (KCL), Professor Emily Simonoff, told BBC Radio 4’s Today program that young people and their parents who attended services for gender distress “were telling us they didn’t know what to do, they were looking at the information out there and they didn’t know what was best for them”.

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

“We look a lot at the balance between possible benefits and possible risks or harms to mental health and quality of life.”

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

puberty blockersHormones, also known as puberty-suppressing hormones (PSH), are drugs used to delay or prevent puberty from occurring.

They were used to treat some teens who were gender nonconforming (when someone’s gender identity does not match the sex they were registered with at birth) or experienced gender dysphoria when it caused significant distress.

As a result of uncertainty about the safety of medications, cass review Pediatrician Dr. Led by Hilary Cass, doctors in gender care can now only offer the treatment to those under 18 as part of a research study.

Last year the government launched a UK-wide rollout. indefinite ban It concerns the prescribing of medicines privately and on the NHS to children and young people who are questioning their sexual identity.

The new clinical trial, called Pathway, will include children diagnosed with gender nonconformity who are currently accessing gender services.

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

A team of specialist NHS doctors must have full information about the young person’s health before deciding whether they are suitable for treatment.

The young person will also need to show that they have a sufficiently good understanding of the potential impact of taking puberty blockers and have given their consent, and their parents or legal guardians will also need to agree to this. They will be provided with continuous psychological support.

To investigate the effect of the drugs, the researchers plan to start treatment immediately for one group and after 12 months for the other group. Children in these groups will be selected randomly.

KCL researchers said there would be no minimum age to take the drug, but puberty normally begins around the age of 11 in girls and 12 in boys.

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

The trial has been given ethical approval and is expected to start in January, with five to six children being recruited each month, the research team said. First results are expected in about four years.

Alongside this, a larger observational study involving 3,000 children will investigate different types of support and how effective they are.

The puberty blockers’ case has already become controversial, with campaigners threatening legal action.

Keira Bell, who took the Tavistock gender clinic to court in 2020 after being given puberty blockers and cross-sex hormones as a teenager, said the case should be stopped immediately. Otherwise he said he and another campaigner would launch judicial review proceedings in the High Court.

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

In his case, Supreme Court rules under-16s ‘unlikely to give informed consent’ to puberty blockers, but this was later overturned by the Court of Appeal, which ruled that: doctors can decide whether young people can consent to treatment.

Some clinicians from the Gender and Gender Clinical Advisory Network, which campaigns for rigorous science and improved treatment options for people questioning gender, have also questioned whether the research could be carried out ethically.

Study leader Prof Simonoff said: “We know there is ongoing public debate around 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 non-conforming young people.”

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

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