New puberty blockers trial to begin after UK ban

The results of a new UK clinical trial to determine the risks and benefits of puberty-blocking drugs in children who are questioning their gender have been revealed. It comes following the outlawing of the drugs for gender therapy last year, following a large study that sparked questions about the lack of scientific evidence regarding their safety for children under the age of 18. According to researchers from King's College London, the trial will involve around 220 children under the age of 16 who are going through puberty and will investigate the effects of the drugs on their physical, socioeconomic, and emotional health. Any physicians and activists are concerned that the trial is ethical.

Young people and their parents attending services for gender dysphoriatry tell us that they don't know what to do, says BBC Radio 4's Today show that they do not know what is best for them. However, she said that the report did not expect a one size fits all finding.

We are really concerned about the balance between, potentially, mental stability and quality of life, and any potential risks or harms.

This will include monitoring people's physical wellbeing, as well as the first ever research into brain growth. Puberty blockers, also known as puberty suppressing hormones (PSH), are drugs that can delay or prevent pubertying. They were used to treat some young people with gender incongruence - when someone's gender identity matches the sex they were born with - or with gender dysphoria, which can cause significant distress. Doctors can now only offer the treatment to children under the age of 18 as a result of the confusion surrounding the drugs' safety, which was highlighted by the Cass reviewinto gender care, led by paediatrician Dr Hilary Casson. Last year, the government introduced a UK-wide ban on the drugs being prescribed or by the NHS to children and young people who are questioning their gender identity.

Children who are currently using gender services and have a diagnosis of gender incongruence will be included in the new clinical trial, Pathway. They will all have puberty by the age of 16, but not by more than 16 years old, and they'll have to pass stringent medical and psychological testing before being allowed to start using pubertity blockers. A team of specialist NHS doctors must have a complete picture of the patient's wellbeing before deciding whether or not they are suitable for the treatment. The young person will also have to demonstrate that they have a thorough enough knowledge of the dangers of getting puberty blockers to give their permission, and their parent or legal guardian will have to agree. They will be given continuing emotional assistance. The researchers intend to start one group on the therapy right away and another group 12 months later to investigate the effects of the drugs. The children in these groups will be selected randomly. According to the KCL's analysts, there will be no minimum age for taking the drugs, but puberty generally starts around the age of 11 for girls and 12 for boys. The trial will explore topics such as bone density, brain growth, and mental stability and wellbeing as time goes. The trial had been given ethical approval and was scheduled to begin in January, with five to six children recruited every month. The first findings are expected to be available in about four years. A larger observational study involving 3,000 children will look at different types of services and how effective they are.

The puberty blockers trial has already been controversial, with campaigners threatening legal proceedings. Keira Bell, who brought the Tavistock gender clinic to court in 2020 after being given puberty blockers and cross-sex hormones as a child, said the trial should be suspended immediately. If it is not, she and another activist's legal review will begin at the High Court. It was disgusting that children were being placed on the medications when they had already been banned because they were unsafe, she said. In her case, the High Court found that under-16s were unlikely to be able to give informed consent to puberty blockers, but the Court of Appeal reversed this decision, finding that doctors will determine whether young people will consent to the therapy. Any clinicians from the Clinical Advisory Network on Sex and Gender, which advocates for rigorous science and improved treatment options for gender-questioning individuals, have also questioned whether the trial can be carried out ethically.

We know there are ongoing societal debates about gender transition,

study leader Prof. Simonoff said,

this study is solely focused on informing and improving healthcare by better understanding how to properly support young people with gender incongruence.

Dr Hilary Cass said she was very proud that Prof Simonoff and the KCL team were involved in the trial.

My research found a very poor evidence base for the use of puberty blockers for children and young people with gender dysphoria,

she said. In fact, some children had more negative than positive effects than positive ones.

However, considering that there are physicians, children, and families who believe strongly in the beneficial effects of the drugless cure, a trial was the only way forward to make sense of this.

Although a lot of media attention has been devoted to the trial, they have a much larger research program.

She continued. Following the results for young people who do not opt for a medical path will be just as relevant as following those who do. All young people should have access to the highest medical services, according to a spokesperson for charity Stonewall, which advocates for LGBTQ+ people.

We urge the government and policymakers to invest in exceptional health for trans young people and their families to ensure that the voices of trans young individuals and their communities are at the forefront.