Hormone options · Compounded bio-identical hormones
Compounded bio-identical hormones: what you should know.
Compounded bio-identical hormones are made up by a pharmacy to an individual prescription. They are different from TGA-approved menopausal hormone therapy (MHT), which includes body-identical hormones that have been tested for quality, safety and effectiveness. For most women, a TGA-approved option is the recommended first choice. This page explains the difference, what the evidence shows, and the limited situations where a Doctor may consider a compounded preparation.
Bio-identical hormone replacement therapy
Three things worth knowing first
Bio-identical hormone replacement therapy is often shortened to BHRT. The term is used in two different ways, and the difference matters.
01
Body-identical MHT is TGA approved
Estradiol (as a gel, patch or tablet) and micronised progesterone are available as TGA-approved medicines. They are chemically identical to the hormones your body makes, and are made to consistent, tested standards.
02
Compounded BHRT is not TGA approved
Compounded preparations are mixed by a pharmacy for one person. While the raw ingredients may be pharmaceutical grade, the finished product has not been assessed by the TGA for quality, safety or effectiveness, and strength can vary between batches.
03
TGA-approved options come first
Our Doctors recommend TGA-approved MHT as the first choice for most women. Compounded preparations are reserved for specific situations, at your Doctor's discretion.
The research
What the evidence and expert bodies say
What we know. Large cohort studies, including the French E3N study, helped show that body-identical estradiol and progesterone may carry a more favourable risk profile than some older hormone types. That research informed the controlled trials of set-dose products now on the TGA register. Those TGA-approved products are where the safety and effectiveness evidence sits.
What we do not know. Because each compounded prescription is individual, there is no controlled-study evidence that these preparations are safe or effective, or that they work better than TGA-approved MHT.
Known risks. Hormone strength in compounded products can vary between pharmacies and batches. There are reports that some compounded progesterone does not adequately protect the lining of the uterus, which may increase the risk of endometrial hyperplasia or cancer. Saliva hormone tests, sometimes used to adjust compounded doses, are not considered reliable.
Expert positions. The Australasian Menopause Society (AMS) does not recommend compounded bio-identical hormones and supports TGA-approved body-identical options instead. The AMS and the Endocrine Society of Australia endorse the Endocrine Society's statement that there is no rationale for routinely prescribing compounded hormones. The TGA does not assess compounded preparations for safety or effectiveness.
Further reading: Australasian Menopause Society: Bioidentical hormone therapy fact sheet, Mayo Clinic Proceedings article and the PubMed Central article.
When it may be an option
When a compounded preparation may be considered
In line with Pharmacy Board of Australia guidelines, compounding is appropriate only when a suitable TGA-approved product is unavailable or unsuitable. Your Doctor may consider it in situations such as:
TGA-approved options have been tried
Appropriate TGA-approved options, including different doses and forms, have been tried and have not been suitable.
A clinically needed strength is not available
Your Doctor has assessed that you need a dose that no TGA-approved product provides.
A medical reason rules out available products
For example, a documented allergy or intolerance to an ingredient in the TGA-approved products.
These situations are uncommon. Whether a compounded preparation is appropriate is a clinical decision made by your Doctor, after discussing the risks and the TGA-approved alternatives with you. If one is prescribed, your Doctor will explain how it will be monitored, including protection of the uterus where relevant.
Your next step
Talk it through with a Doctor who knows menopause.
Your first appointment is a bulk billed menopause assessment, by telehealth. Your Doctor reviews your history and talks you through evidence-based options, including TGA-approved menopausal hormone therapy and non-hormonal treatments.
Medical disclaimer. The information on this page is general in nature and is not a diagnosis or a recommendation for your circumstances. It does not replace advice from a qualified health practitioner. Compounded preparations are not TGA approved and have not been assessed by the TGA for quality, safety or effectiveness. Treatment decisions, including whether any hormone therapy is appropriate for you, are made with a Doctor who has taken your history. If you need urgent care, contact your GP or the nearest emergency department.