Livial (Tibolone)
Livial is the brand of tibolone 2.5mg tablets, a single synthetic steroid that acts as combined estrogenic, progestogenic and weak androgenic HRT. It is widely used in Europe, Latin America and Asia for postmenopausal symptoms; not available in the United States.
- Active ingredients
- Tibolone
- Manufacturer
- Aspen / Organon
- Dosage forms
- tablet
- Available dosages
- 2.5mg
- Category
- Hormones and Birth Control
What is it?
Livial is the brand name under which Aspen Pharmacare (originally Organon, then MSD) markets tibolone 2.5mg tablets globally — primarily in Europe, Latin America, Asia, Australia and South Africa. Tibolone has never been approved by the FDA, so Livial is not available in the United States, where combined estradiol + progesterone HRT regimens are used instead. Authorised generic tibolone is widely available in markets where it is licensed, and the generic dominates current prescribing.
Active ingredients
Each Livial tablet contains 2.5mg of tibolone, a synthetic steroid prodrug. On absorption, tibolone is rapidly converted to three active metabolites: 3α-OH-tibolone and 3β-OH-tibolone (tissue-selective estrogenic activity in bone, brain and vagina) and Δ4-tibolone (progestogenic and weak androgenic activity). The active substance and its metabolites are identical between branded Livial and authorised generic tibolone tablets.
Forms and dosages
Livial is supplied as 2.5mg oral tablets in 28- or 84-day packs. The standard dose is 2.5mg once daily, taken at the same time each day with or without food. There is no progestogen-free or estrogen-free interval — tibolone is a daily continuous regimen. Lower-dose 1.25mg tablets are not available in most markets but lower exposure can be achieved by halving the 2.5mg tablet (although the manufacturer does not specifically support this).
Indications
Livial is approved (in countries where licensed) for treatment of moderate-to-severe vasomotor menopausal symptoms and prevention of postmenopausal osteoporosis in women at least 12 months past their last natural menstrual period. According to current European menopause guidelines, Livial is restricted to women under 60 within 10 years of menopause because of stroke risk increases shown in the LIFT trial in older women.
How it works
Tibolone in Livial is rapidly converted to three active metabolites with tissue-selective activity. The hydroxylated metabolites have estrogenic activity in bone (preserving bone mineral density), brain (relieving hot flashes and night sweats) and vagina (reducing atrophy), while the Δ4 metabolite has progestogenic activity (protecting the endometrium) and weak androgenic activity (supporting libido). This balanced tissue selectivity means Livial covers the role of combined HRT in a single daily tablet.
Frequently asked questions
How is Livial different from standard HRT? ▾
Standard HRT uses estradiol or conjugated estrogens combined with a progestogen as two separate active ingredients. Livial is a single synthetic steroid (tibolone) that converts to estrogenic, progestogenic and weak androgenic metabolites in a tissue-selective manner. The practical difference is one tablet daily versus two components, plus modest libido benefit from androgenic activity. According to current menopause guidelines, both approaches are reasonable in markets where Livial is available.
Why is Livial not available in the United States? ▾
Tibolone has been used in Europe since 1988 but the manufacturer never sought FDA approval, partly because the regulatory development pathway for tissue-selective combination effects is complex and the US market favoured separate estrogen + progestogen products. According to current US menopause guidelines, US prescribers do not have access to tibolone and use combined estradiol + micronised progesterone instead.
Is Livial safer than combined HRT? ▾
Livial has a similar overall safety profile to combined HRT — small increases in stroke (especially over 60), VTE and a complex breast cancer signal that may be slightly more favourable than estrogen + medroxyprogesterone HRT. The LIFT trial showed reduced breast cancer recurrence in early-stage cancer survivors but increased stroke risk in older women. According to current European menopause guidelines, Livial is restricted to women under 60 within 10 years of menopause.
Why might women bleed during the first months of Livial? ▾
Vaginal bleeding or spotting during the first 3 months is common when starting Livial because the synthetic steroid causes endometrial changes during the adjustment period. According to the prescribing information, persistent or recurrent bleeding after 3 months warrants pelvic and endometrial assessment to exclude underlying pathology. Bleeding is usually self-limiting and not a reason to stop early.
Is Livial the same as generic tibolone? ▾
Yes — Livial and authorised generic tibolone tablets contain the same active ingredient at the same strength and have demonstrated bioequivalence. The generic is significantly cheaper and clinically equivalent in nearly all cases. Most current prescribing in markets where tibolone is available is on the authorised generic; the Livial brand remains a recognisable name globally.
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The information on this website is provided for reference and educational purposes only. It does not replace consultation with a qualified healthcare professional.