Protocol
Menopausal hormone therapy (MHT)
HRT · menopausal HRT · hormone replacement therapy · oestrogen/progestogen therapy · MHT · systemic oestrogen therapy · local vaginal oestrogen
MHT has genuine randomised human evidence, which is rare in this field, but the evidence supports symptom relief and bone outcomes far more strongly than it supports lifespan extension. What is well established: MHT is the most effective treatment for vasomotor symptoms, and it prevents bone loss and reduces fragility fractures. Australian Prescriber notes it is recommended regardless of symptoms in premature ovarian insufficiency to reduce osteoporosis and cardiovascular risk. The Women's Health Initiative, a randomised placebo-controlled trial in women aged 50 to 79 with an intact uterus, was stopped early in 2002 after conjugated equine oestrogen plus medroxyprogesterone acetate showed increased breast cancer incidence and an unfavourable overall benefit-risk ratio; oestrogen alone showed a different, more favourable breast cancer signal. Longer follow-up and the "timing hypothesis" literature suggest reduced all-cause mortality and coronary heart disease when MHT is started under age 60 or within 10 years of the final menstrual period, but this is largely post hoc subgroup and meta-analytic evidence, not a prospective trial designed to test longevity, and it should not be read as proof that MHT extends life. What it does NOT show: no trial has tested MHT against a primary endpoint of healthspan, biological age or all-cause mortality in the general population; benefit is age- and timing-dependent and does not transfer to late initiation; and breast cancer, VTE and stroke risks are real and dose-, route- and regimen-dependent. Separately, custom-compounded "bioidentical" hormone therapy, which several longevity clinics market, is explicitly not recommended by Australian Prescriber because of limited dose regulation and lack of safety data, and compounded products sit outside the ARTG. The evidence supporting registered MHT does not transfer to compounded formulations.
At a glance
- Evidence
- Clinical
- Singapore (HSA)
- Registered prescription therapy. HSA regulates locally registered HRT products, and its safety communications refer to oral combination oestrogen-plus-progestogen preparations registered in Singapore, all of which use estradiol rather than conjugated oestrogens, with HSA advising use at the lowest effective dose for the shortest duration, regular review, and contraindication in known, past or suspected breast cancer. Approved use is menopausal symptom management, not longevity or healthspan extension; any anti-ageing framing is off-label positioning. Caveat: I did not open an individual HSA product register entry in this session, so the registration status of any specific brand is unverified here. Compounded "bioidentical" hormone preparations offered by some clinics are not registered products and should be treated as a separate, unapproved category.
- Australia (TGA)
- Registered prescription therapy. MHT products containing estradiol or conjugated equine oestrogens, plus progestogens and tibolone, are included in the ARTG and available in oral, transdermal patch, gel and vaginal forms, with the principal approved indication being relief of menopausal symptoms, notably vasomotor symptoms, and prevention of bone loss. Australian Prescriber notes that most non-hormonal alternatives are NOT TGA-registered for vasomotor symptoms, implying MHT holds the registered position for that indication. Longevity or healthspan use is off-label. Custom-compounded bioidentical hormone therapy is not TGA-approved, falls under the TGA's unapproved/compounded medicines framework, and is not recommended in Australian prescribing guidance due to limited dose regulation and absent safety data. Caveat: I did not open an individual ARTG entry in this session, so a specific product's registration details are unverified here.
- Offered at
- 3 clinics
Singapore
Health Sciences Authority
- HSA status
- Registered prescription therapy. HSA regulates locally registered HRT products, and its safety communications refer to oral combination oestrogen-plus-progestogen preparations registered in Singapore, all of which use estradiol rather than conjugated oestrogens, with HSA advising use at the lowest effective dose for the shortest duration, regular review, and contraindication in known, past or suspected breast cancer. Approved use is menopausal symptom management, not longevity or healthspan extension; any anti-ageing framing is off-label positioning. Caveat: I did not open an individual HSA product register entry in this session, so the registration status of any specific brand is unverified here. Compounded "bioidentical" hormone preparations offered by some clinics are not registered products and should be treated as a separate, unapproved category.
- In our SG set
- Tracked in Singapore
- SG clinics
- 2
Australia
Therapeutic Goods Administration
- TGA status
- Registered prescription therapy. MHT products containing estradiol or conjugated equine oestrogens, plus progestogens and tibolone, are included in the ARTG and available in oral, transdermal patch, gel and vaginal forms, with the principal approved indication being relief of menopausal symptoms, notably vasomotor symptoms, and prevention of bone loss. Australian Prescriber notes that most non-hormonal alternatives are NOT TGA-registered for vasomotor symptoms, implying MHT holds the registered position for that indication. Longevity or healthspan use is off-label. Custom-compounded bioidentical hormone therapy is not TGA-approved, falls under the TGA's unapproved/compounded medicines framework, and is not recommended in Australian prescribing guidance due to limited dose regulation and absent safety data. Caveat: I did not open an individual ARTG entry in this session, so a specific product's registration details are unverified here.
- 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
Menopausal hormone therapy is the prescription replacement of oestrogen, given alone after hysterectomy or combined with a progestogen in women with an intact uterus to protect the endometrium, delivered as oral tablets, transdermal patches or gels, or as low-dose local vaginal preparations. It is a mainstream, regulator-approved treatment for menopausal symptoms, not a novel longevity intervention. Within longevity clinics it is additionally positioned as a healthspan lever for bone, cardiovascular and cognitive ageing, which is a broader claim than the approved indications support.
Categories
Protocol
Offered by
Where variis has verified this protocol (3)
Keep reading
Related coverage from the newsroom.
Sources
What this profile is built on
- Menopausal Hormone Therapy (MHT) in Singapore · ATA Medical
- Hormone Replacement Therapy (HRT) Singapore · ATA Medical
- Hormone Replacement Therapy in Singapore · Osler Health International
- Menopause Treatment Sydney · Evergreen Doctors
- Management of menopause · Australian Prescriber (Therapeutic Guidelines)
- HRT safety update · Health Sciences Authority, Singapore (surfaced via search; direct fetch returned 404)
- Compounded medicines · Therapeutic Goods Administration
- About the shortage of transdermal HRT patches · Therapeutic Goods Administration
- Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality: The Women's Health Initiative Randomized Trials · JAMA / PubMed
- Managing menopausal symptoms (C-Gyn 9) · RANZCOG
Every entity profile on variis is sourced. Not medical advice.