Protocol
Bioidentical hormone therapy
BHRT · cBHT · compounded bioidentical hormones · bio-identical hormone support · body-identical hormone therapy
"Bioidentical" is a marketing term, not a regulatory or pharmacological category, and this is the central thing to understand about it. Regulator-approved body-identical products (transdermal estradiol, micronised progesterone, testosterone) have genuine randomised evidence, but for symptom control in menopause and for treating diagnosed hypogonadism, not for extending healthspan or lifespan. Custom compounded bioidentical preparations are a separate case: the 2020 US National Academies review found a lack of rigorous safety and effectiveness evidence from well-designed or properly controlled studies, and recommended their use be restricted. The Australasian Menopause Society states it cannot endorse compounded bioidentical therapy, noting there are no data on the efficacy of compounded oestrogen for maintaining bone density, that compounded progesterone delivery has been documented as inadequate for endometrial protection with associated endometrial cancer risk, and that excipients in the preparations are unknowable. Salivary hormone testing, frequently bundled with BHRT programmes to justify dosing, is not a validated basis for titration. There is no clinical trial evidence that any bioidentical hormone regimen, compounded or pharmaceutical, extends lifespan, slows biological ageing, or improves a hard healthspan endpoint in people without a hormone deficiency. The gap between what is sold and what is shown is wide, which is why this grades commercial rather than clinical.
At a glance
- Evidence
- Commercial
- Singapore (HSA)
- "Bioidentical hormone therapy" is not an HSA approval category. Individual body-identical hormone medicines (estradiol, micronised progesterone, testosterone) are HSA-registered prescription therapeutic products, indicated for menopausal symptoms and male hypogonadism respectively; use for general "longevity" or anti-ageing purposes is off-label. Custom compounded bioidentical preparations are not HSA-registered and have not been evaluated by HSA for quality, safety or efficacy. HSA permits licensed healthcare institutions and retail pharmacies to compound without a manufacturer's licence only under specific conditions: the final compounded product must not be commercially available in Singapore, compounding must occur on the licensed premise under a pharmacist or qualified practitioner, an appropriate expiry date must be documented, and prescription-only ingredients require a valid prescription. So compounded BHRT is lawful in narrow circumstances but carries no regulatory assessment.
- Australia (TGA)
- "Bioidentical hormone therapy" is not a TGA approval category. Pharmaceutical body-identical hormones are TGA-registered on the ARTG (estradiol patches, gels and tablets; micronised progesterone as Prometrium/Utrogestan; testosterone products) and several are PBS-listed, approved for menopausal symptoms and male hypogonadism; longevity or anti-ageing use is off-label. Compounded bioidentical preparations are a different matter: they are exempt from ARTG inclusion under the extemporaneous compounding provisions of the Therapeutic Goods Regulations 1990, where a medicine is compounded for a particular person for therapeutic application to that person and not held as routine stock. Compounding in anticipation of demand is prohibited outside hospital settings. The exemption means the TGA has not evaluated these preparations for quality, safety or efficacy. The Australasian Menopause Society does not recommend compounded bioidentical hormone therapy in any form.
- Offered at
- 2 clinics
Singapore
Health Sciences Authority
- HSA status
- "Bioidentical hormone therapy" is not an HSA approval category. Individual body-identical hormone medicines (estradiol, micronised progesterone, testosterone) are HSA-registered prescription therapeutic products, indicated for menopausal symptoms and male hypogonadism respectively; use for general "longevity" or anti-ageing purposes is off-label. Custom compounded bioidentical preparations are not HSA-registered and have not been evaluated by HSA for quality, safety or efficacy. HSA permits licensed healthcare institutions and retail pharmacies to compound without a manufacturer's licence only under specific conditions: the final compounded product must not be commercially available in Singapore, compounding must occur on the licensed premise under a pharmacist or qualified practitioner, an appropriate expiry date must be documented, and prescription-only ingredients require a valid prescription. So compounded BHRT is lawful in narrow circumstances but carries no regulatory assessment.
- In our SG set
- Tracked in Singapore
- SG clinics
- 1
Australia
Therapeutic Goods Administration
- TGA status
- "Bioidentical hormone therapy" is not a TGA approval category. Pharmaceutical body-identical hormones are TGA-registered on the ARTG (estradiol patches, gels and tablets; micronised progesterone as Prometrium/Utrogestan; testosterone products) and several are PBS-listed, approved for menopausal symptoms and male hypogonadism; longevity or anti-ageing use is off-label. Compounded bioidentical preparations are a different matter: they are exempt from ARTG inclusion under the extemporaneous compounding provisions of the Therapeutic Goods Regulations 1990, where a medicine is compounded for a particular person for therapeutic application to that person and not held as routine stock. Compounding in anticipation of demand is prohibited outside hospital settings. The exemption means the TGA has not evaluated these preparations for quality, safety or efficacy. The Australasian Menopause Society does not recommend compounded bioidentical hormone therapy in any form.
- In our AU set
- Tracked in Australia
- AU clinics
- 1
Evidence is not approvalAn evidence grade describes how strong the science is. A regulatory status describes whether a body has approved the intervention for an indication. They are different questions, answered separately above.
What it is
Plain-language explainer
Bioidentical hormone therapy describes hormones (typically estradiol, progesterone, testosterone, DHEA) that are chemically identical to those the human body produces. The term covers two very different things: regulator-approved pharmaceutical "body-identical" products, and custom compounded preparations (creams, troches, lozenges, implanted pellets) mixed by a compounding pharmacy to an individual prescription. It is marketed in longevity settings as a more "natural", individually titrated way to restore hormones and slow age-related decline.
Categories
Protocol
Offered by
Where variis has verified this protocol (2)
Keep reading
Related coverage from the newsroom.
Sources
What this profile is built on
- Compounding of therapeutic products · Health Sciences Authority (Singapore)
- How therapeutic products are regulated by HSA · Health Sciences Authority, Singapore
- Compounded medicines · Therapeutic Goods Administration
- Manufacturing, supplying and advertising compounded medicines lawfully · Therapeutic Goods Administration (Australia)
- Bioidentical custom compounded hormone therapy, information sheet · Australasian Menopause Society
- The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use (2020) · National Academies of Sciences, Engineering, and Medicine
- The Clinical Utility of Compounded Bioidentical Hormone Therapy, full report · NCBI Bookshelf
- Hormone Replacement Therapy (HRT) Singapore · ATA Medical
- Female Hormone Specialist Sydney · Evergreen Doctors
Every entity profile on variis is sourced. Not medical advice.