General principles of prescribing gender-affirming hormones

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The general principles of prescribing gender-affirming hormones can be summarised as follows.

·       The goal of gender-affirming hormone therapy is to align physical appearance with gender identity to reduce distress and improve wellbeing.

·       Hormone therapy should be individualised –there is no ‘one size fits all’.

·       When prescribing hormone therapy, it is important to start with low doses and titrate up gradually.

·       Gender-affirming hormone therapy is usually, but not always, lifelong. Some patients choose to cease hormones once the desired changes have occurred.

Informed consent model of care

In2017, the Equinox Gender Diverse Health Centre in Melbourne (Thorne Harbour Health) produced the first Australian guideline for an ‘informed consent’ model of care, Protocols for the initiation of hormone therapy for trans and gender diverse patients. The guideline is based on a similar protocol that was successfully implemented in the USA. The guideline is endorsed by the Australian Professional Association for Transgender Health (AusPATH) and the Gender Clinic, Monash Health, Victoria. Under an informed consent model of care, the treating GP is the main care provider. There is an emphasis on self-determination, patient-centered care and mental health support. Mental health support can be provided by a counsellor, GP, psychologist, psychiatrist or peer worker depending on the patient’s needs. If the patient is unable to give informed consent or has severe unstable mental health concerns such as active psychosis, a psychiatry review is recommended prior to initiation of gender-affirming hormones. Depression and anxiety are common in the trans and diverse gender population and are not a contraindication to the commencement of gender-affirming hormones.

Before initiating gender-affirming hormones, it is important to confirm a history of gender incongruence. This is self-determined by the patient. A patient will typically describe a persistent incongruence between their gender identity and their birth-assigned gender. It is important to spend time counselling the patient about hormone therapies and exploring their psychosocial situation and supports. This may be covered in a relatively short time or may require several consultations. The length of time required depends on the level of experience of the treating GP and the complexity of the presentation.

Pre-commencement visits provide an invaluable opportunity to provide preventive care, sexual health screening and general health checks. A suggested checklist for use prior to commencing gender-affirming hormones follows.

·       Confirm history of gender incongruence(self-determined by the patient).

·       Take a comprehensive medical history and family history to exclude contraindications to hormone therapies.

·       Perform a mental health assessment and offer referral for counselling or peer support.

·       Explore the patient’s ideas, concerns and expectations

·       What are their goals?

·       Do they have any concerns?

·       What are their expectations? Are they realistic?

·       Discuss expected changes resulting from hormone use and an expected timeline for changes.

·       Discuss potential complications and side effects of gender-affirming hormones.

·       Check baseline blood pressure and body mass index.

·       Organise baseline blood tests including follicle-stimulating hormone, luteinising hormone, oestradiol, totaltestosterone, full blood examination, urea and electrolytes, and liver function tests. Consider glycated haemoglobin and fasting lipids if the patient is aged>40 years or if additional cardiovascular risk factors are present.

·       Offer referral for sperm-cryopreservation prior to commencement of feminising hormones.

·       Assess and document capacity to give informed consent.

Regular clinical review is essential after commencement of gender-affirming hormones. Visits should include a mental health review, blood tests, blood pressure, body mass index, counselling and advice.

Feminising hormones

The most commonly prescribed feminising hormone for trans and other gender-diverse people in Australia is oestradiol valerate. Ethinylestradiol is no longer the preferred option because of concerns it may confer a higher thrombotic risk.

Transdermaloestradiol is another option and is preferred over oral oestradiol for patients aged >40 years and those with risk factors for thromboembolic disease. Oestradiol subcutaneous implants are preferred by many patients; however, these products can be difficult to access in Australia and can be financially prohibitive as they are not available on the Pharmaceutical Benefits Scheme(PBS).

Patients should be counselled that physical changes with oestrogen are likely to be slow and will vary between individuals.

Early changes with oestrogen include:

·       Calmer mood

·       Softer skin

·       Reduction in libido

·       Erectile dysfunction.

·       Changes that occur over the followingsix-to-twelve months include:

·       Body fat redistribution (a more curvy bodyshape)

·       Decreased muscle mass

·       Decreased testicular volume

·       Breast development (can take up to threeyears).

Oestrogen does not alter the voice. If their voice is causing distress, the patient can be offered a referral to a speech pathologist for voice feminisation therapy.

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Side effects

Side effects of oestradiol are similar to those of the oral contraceptive pill. Nausea and weight gain may occur. More serious side effects include deep vein thrombosis, gallstones, infertility and liver impairment. Fertility is reduced soon after commencing oestrogen because of reduced spermatogenesis and atrophy of seminiferous tubules. Sperm cryopreservation should be discussed prior to commencement of gender-affirming hormones. Smokers should be warned of the cumulative risk of smoking on thrombosis risk and supported to quit.

Monitoring

Blood tests should be organised on a three-monthly basis during the first year, then six-to-twelve–monthly in the longer term to check oestradiol and testosterone levels, liver function, urea and electrolytes and full blood examination.

There is ongoing debate about the optimum range for oestradiol levels in this setting. As a general guide, an oestradiol level in the cis-female(non-transgender female) range of 300–800 pmol/L is reasonable. There can be considerable variability between oestradiol levels, and it is important not to become too fixated on ‘the levels’.

If the patient is happy with how their transition is progressing, the dose does not necessarily need to be adjusted. It is important to ensure oestradiol levels are not too high (>1000 pmol/L) as this may predispose the patient toa higher risk of adverse effects. Non-binary patients may prefer a target oestradiol level between the male and female range.

Oestrogen therapy will usually suppress testosterone levels but often not to the desired level. In this case, the GP can consider prescribing an anti-androgen.

Anti-androgens

Anti-androgens are usually prescribed alongside oestradiol to reduce testosterone levels. The most commonly prescribed anti-androgens for gender transition in Australia are spironolactone and cyproterone acetate.

Cyproterone acetate is a more potent anti-androgen than spironolactone and has progestogenic properties. An Australian study is currently underway to ascertain the optimum cyproteroneacetate dose in this setting (Dr J Dean, ‘GoLoCypro: Titrating the lowest effective dose of cyproterone acetate for treatment of trans and gender diverse people who request feminizing hormones [2019–2021]’, The University of Queensland).

Some people choose not to take an anti-androgen, including those who wish to preserve erectile function.

Patient staking anti-androgens should be counselled that physical changes are likely to be slow and will vary between individuals.

Effects of anti-androgens include:

·       slower growth of body hair

·       reduction of acne

·       reduction in libido

·       erectile dysfunction.

Facial hair usually persists. Laser or electrolysis treatments may be indicated.

Information adapted from:  RACGP- Hormone therapy for trans and gender diverse patients in the general practice setting

Masculinising hormones

The most commonly prescribed masculinising hormone for gender affirmation in Australia is testosterone undecanoate. Other options include fortnightly depot testosterone injections and transdermal preparations. Fortnightly injections have become less popular in recent years because of the resultant peaks and troughs of testosterone levels and the potential for mood lability. Transdermal testosterone is a good option for patients who are needle phobic or prefer the convenience of a topical product. The gels tend to be sticky and an take several minutes to absorb.

In contrast to feminising hormones, testosterone can cause physical changes relatively quickly, and patients should be counselled to this effect. Within six months of commencement of masculinising hormones, the patient’s appearance will usually be much changed.

Early changes with testosterone include:

• acne
• oily skin
• increased libido
• increase in clitoral size.

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Changes that occur over the following six-to-twelve months include:

• amenorrhea
• body fat redistribution
• muscle growth
• increase in body and facial hair
• voice deepening.

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Information adapted from:  RACGP- Hormone therapy for trans and gender diverse patients in the general practice setting

Getting Treatment: what to do if you are trans and under 18

This information is from a fact sheet which sets out the law about when and how transgender young people under the age of 18 can access hormonal and medical treatment to help them to transition to their affirmed gender. This is general information and should not be taken as a substitute for legal advice tailored to your particular circumstances.  

In general, the law places some restrictions on when and how transgender children(ie young people under the age of 18) can access treatment to help them to transition to their affirmed gender. In some cases, court involvement is mandatory.

Background

Under Australian law, parents can generally give consent to medical treatment for their children.  It is also not uncommon for children to provide their own consent to medical and dental procedures as they get closer to the age of 18.  However, there are some forms of medical treatment that are outside this general principle and are considered to be ‘special medical procedures. (They are‘ special’ in the sense of being unusual). Neither parent nor child can give legally valid consent to a special medical procedure in the absence of court involvement. Court involvement is required for special medical procedures because:

•There is significant risk of making a wrong decision.

•The consequences of a wrong decision are particularly serious; and

•Treatment is invasive, permanent and irreversible, and not for the purposes ofcuring a (physical)

malfunction or disease.

Undersection 67ZC of the Family Law Act 1975 (Cth), the Family Court has the power to make orders relating to the welfare of children (defined as a person under the age of 18). Court applications about special medical procedures are made under this section.

Whether treatment requires court involvement depends broadly on:

• Whether there is disagreement’ (e.g. active opposition rather than support) between any of the parents and the medical team and the child about the treatment; and

•Whether the treatment is reversible.

The legal requirements for each stage of treatment.

Stage1 treatment: blockers  

If a child’s parents and the treating medical team agree that the child should start on treatment to delay the onset or progression of puberty, there is no requirement for court involvement. Treatment can commence when the child’s treating medical team considers it appropriate.

If there is disagreement, there must be an application asking the court to make a decision about whether the treatment should be authorised. In deciding whether to authorise treatment, the court will have regard to the best interests of the child as the paramount consideration, and will give significant weight to the views of the child in accordance with his or her age and maturity.

Stage2 treatment: oestrogen or testosterone

Court involvement is mandatory before a transgender child can start Stage 2 treatment (oestrogen or

testosterone).This is because many of the effects of stage 2 treatment are only reversible with surgical

intervention. If there is any dispute between the child’s parents and members of the treating medical team, then the court must consider whether the treatment should be authorised on the basis that it is in the best interests of the child.

If there is no dispute, then the court must decide whether the child is competent to provide their own consent to the treatment.

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1. For a child to be competent to the relevant standard (Gillick competent) they must have reached ‘a sufficient understanding and intelligence to understand fully what is proposed’. This test takes its name from an English case, Gillick v West Norfolk and Wisbech Area.  See Re Jamie [2013] FamCAFC 110.

2.  An application for a declaration of competence will also ask ‘in the alternative’ (in other words as a plan B) that the court authorise the treatment on the basis that it is in the best interests of the child if the child is not found to be competent to the relevant standard.

Getting treatment: what to do if you are trans and under 18

Health Authority [1986] AC 112.3 Whether the child is competent will generally depend on whether they are able to demonstrate that they understand the content of the treatment, its side-effects, its negative risks, and the physical changes that it will cause.  

Procedure  

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The court application is supported by:  

• Affidavit evidence from the parent or parents filing the application (about the young person, their transition, and their understanding of the treatment);  

• Expert evidence from the child’s treating psychiatrist regarding the diagnosis of gender dysphoria and whether the child is Gillick competent; and

• Expert evidence from the child’s treating endocrinologist about the content of the proposed treatment and whether the child is Gillick competent.  

Evidence may also be supplied from a psychologist or counsellor. The evidence is usually dealt with without

witnesses attending court. The young person gives no evidence.  

The Family Law Rules (the court rules for the Family Court) require the service of applications of this kind on any parent who is not an applicant, and on the ‘prescribed child welfare authority’.

Itis routine for the court to appoint an independent children’s lawyer. An independent children’s lawyer represents the best interests of the child. They are obliged to consider the views of the child, but ultimately provide their own, independent perspective about what arrangements or decisions are in the child’s best interests. The independent children’s lawyer is usually a Legal Aid employee, and some costs are payable to Legal Aid by the parent or parents making the court application unless they are able to demonstrate financial hardship.

Stage3 Treatment: surgery  

The legal principles and process are the same as for Stage 2 treatment (although top surgery is irreversible).  The only difference is that the application is supported by an affidavit from a plastic surgeon, rather than an affidavit from an endocrinologist.

Treatment without court involvement  

Although that case relates to treatment of children under the age of 16, Gillick has been applied in Australian law in relation to children under the age of18.  Where court involvement is required, neither a parent nor the young person can give valid consent to the treatment unless that court process takes place. Medical treatment that takes place without the required court involvement is unlawful and it is possible that it may lead to criminal charges, or the involvement of child protection services.

What if my parents aren’t in my life?

If you are a young person under 18 and you want to have treatment (and your parents are not part of your life or are not supportive), then the law about your situation is different.  As it is too complex to set out clearly here, we encourage you to contact legal advice from your local gender clinic and community legal service.

Getting_treatment-_what_to_do_if_you_are_trans_and_under_182.pdf(gendercentre.org.au)

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