Kliovance

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Kliovance on Prescriptsy

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Kliovance is a prescription-only, low-dose continuous combined hormone replacement therapy (HRT) tablet used to relieve menopausal symptoms and to help prevent postmenopausal osteoporosis.

Each tablet contains 1 mg estradiol and 0.5 mg norethisterone acetate.

It is designed for postmenopausal women who have not had a natural menstrual period for at least 12 months and who still have a uterus.

The continuous combined formulation means both the oestrogen and the progestogen are taken every day, avoiding the cyclical withdrawal bleeds associated with sequential HRT regimens.

Kliovance is manufactured by Novo Nordisk and has been widely prescribed in UK clinical practice for many years.

The menopause is a natural stage of life that occurs when the ovaries stop producing eggs and oestrogen levels decline.

In the United Kingdom, the average age of menopause is 51, though it can occur earlier (premature ovarian insufficiency if before age 40) or later.

Menopausal symptoms vary widely in severity and duration. Common symptoms include hot flushes, night sweats, vaginal dryness, reduced libido, sleep disturbance, mood changes, difficulty concentrating, and joint aches.

Some women experience minimal disruption, while others find that symptoms significantly impair their quality of life, work performance, and personal relationships.

HRT remains the most effective treatment for vasomotor symptoms (hot flushes and night sweats) and is recommended by NICE (NG23) when the benefits outweigh the risks.

Important safety information about Kliovance

Before reading further, note these essential safety points about Kliovance.

• Kliovance is a prescription-only medicine (POM) and must be used under medical supervision.
• It is only suitable for postmenopausal women who have not had a period for at least 12 months.
• Women who have had a hysterectomy should use oestrogen-only HRT, not a combined product like Kliovance.
• Combined HRT carries a small increased risk of breast cancer, blood clots, and stroke. These risks must be weighed against the benefits.
• Attend regular reviews with your prescriber, at least once a year, to reassess whether HRT remains appropriate for you.
• Report unexplained vaginal bleeding, breast lumps, chest pain, leg swelling, or sudden breathlessness to your doctor urgently.

Understanding the menopause and why HRT is used

The menopause occurs when the ovaries cease follicular activity and oestrogen production falls permanently.

This hormonal shift triggers the symptoms described above and has longer-term consequences for bone health and cardiovascular risk.

In the years following menopause, the rate of bone loss accelerates, increasing the risk of osteoporotic fractures of the hip, spine, and wrist.

Cardiovascular disease risk also rises after menopause, partly due to the loss of the protective effects of oestrogen on lipid metabolism and vascular function.

HRT works by replacing the oestrogen that the body no longer produces in sufficient quantities.

For women who still have a uterus, a progestogen is added to protect the endometrium (the lining of the womb) from the stimulatory effects of unopposed oestrogen, which can lead to endometrial hyperplasia and, over time, endometrial cancer.

Continuous combined HRT provides both hormones every day, which typically results in endometrial atrophy and the absence of withdrawal bleeds after an initial settling-in period.

How Kliovance works: mechanism of action

Estradiol, the oestrogen component of Kliovance, is identical to the principal oestrogen produced by the ovaries before menopause.

After oral administration, estradiol is absorbed from the gastrointestinal tract and undergoes first-pass hepatic metabolism, being converted partly to estrone and estrone sulphate.

These metabolites circulate in the blood and are interconverted, maintaining a pool of bioactive oestrogen.

Estradiol binds to oestrogen receptors (ER-alpha and ER-beta) throughout the body, restoring oestrogenic activity in tissues affected by menopausal hormone decline.

In the hypothalamus, this helps stabilise the thermoregulatory centre, reducing the frequency and severity of hot flushes.

In the urogenital tract, it restores vaginal epithelial thickness, moisture, and elasticity. In bone, it inhibits osteoclast-mediated resorption, slowing the rate of bone loss.

Norethisterone acetate, the progestogen component, is a synthetic progestogen derived from 19-nortestosterone.

It is converted in the body to norethisterone, which binds to progesterone receptors in the endometrium, counteracting the proliferative effect of oestrogen and promoting secretory transformation followed by atrophy when given continuously.

This protective effect is the primary reason for including a progestogen in HRT for women with a uterus.

Norethisterone acetate also has weak androgenic properties, which may contribute to improvements in libido and energy in some women, though these effects are variable.

Clinical evidence and UK prescribing guidance

The efficacy of continuous combined HRT containing estradiol and norethisterone acetate in relieving menopausal symptoms has been demonstrated in multiple randomised controlled trials.

Clinical studies of Kliovance specifically have shown significant reductions in the frequency and severity of hot flushes compared with placebo, with most women achieving satisfactory symptom control within 4 to 8 weeks of starting treatment.

Breakthrough bleeding rates are generally low with the low-dose formulation, typically affecting fewer than 15% of women after 6 months of use.

NICE guideline NG23 (Menopause: diagnosis and management) recommends HRT as the first-line treatment for vasomotor symptoms and advises that the benefits and risks should be discussed individually with each woman.

The guideline emphasises that the risks of HRT are generally low for women who start treatment under the age of 60 or within 10 years of menopause.

For osteoporosis prevention, NICE recommends HRT as an option for women at increased risk of fragility fractures who are unable to take other bone-protective treatments such as bisphosphonates.

The British Menopause Society (BMS) supports the use of low-dose HRT preparations where effective symptom control can be achieved, as lower hormone doses are associated with fewer side effects while maintaining clinical efficacy.

The BMS also advises that there is no arbitrary limit on the duration of HRT use and that the decision to continue should be based on ongoing clinical review.

Kliovance compared with other HRT options

The HRT landscape in the UK includes a wide range of preparations.

Sequential (cyclical) regimens, such as Elleste Duet or Femoston, provide oestrogen daily with progestogen added for 12 to 14 days per cycle, producing a regular monthly withdrawal bleed.

These are used during the perimenopause or early postmenopause.

Continuous combined regimens, including Kliovance, Kliofem, Elleste Duet Conti, and Femoston Conti, are used only in established postmenopausal women and aim to provide bleed-free HRT.

Within the continuous combined category, Kliovance is distinguished by its lower hormone doses.

Kliofem, its higher-dose counterpart from the same manufacturer, contains 2 mg estradiol and 1 mg norethisterone acetate.

The lower dose in Kliovance may be preferable for women who are sensitive to side effects, who are older and further from menopause, or who are using HRT primarily for osteoporosis prevention rather than severe vasomotor symptoms.

Women with particularly severe hot flushes may find the higher-dose Kliofem more effective, but many will achieve adequate relief with Kliovance.

Transdermal HRT (patches and gels) bypasses first-pass hepatic metabolism and may carry a lower risk of venous thromboembolism than oral formulations.

Women with risk factors for VTE, liver disease, migraine with aura, or malabsorption conditions may be advised to use transdermal rather than oral HRT.

Combined transdermal options include the Evorel Conti patch (estradiol with norethisterone acetate).

Tibolone is a synthetic steroid with oestrogenic, progestogenic, and weak androgenic activity, used as an alternative to conventional combined HRT.

Body-identical (micronised) progesterone (Utrogestan) combined with transdermal estradiol is another increasingly popular option, as some evidence suggests micronised progesterone may carry a lower breast cancer risk than synthetic progestogens.

Dosage and administration

Take one Kliovance tablet once daily, at approximately the same time each day. The tablet can be taken with or without food. Swallow it whole with water.

Treatment is continuous, with no tablet-free days. If you miss a dose, take it as soon as you remember on the same day.

If more than 12 hours have passed, skip it and take the next tablet at the usual time. Do not double up.

Your prescriber will typically start you on Kliovance if you are at least 12 months past your last natural period.

If you are switching from a sequential HRT regimen, start Kliovance on the day after completing the progestogen phase of your previous cycle.

If switching from another continuous combined product, the change can be made on any convenient day.

The lowest effective dose should be used for the shortest duration necessary to control symptoms, though there is no mandatory maximum treatment length.

Annual review allows your prescriber to reassess whether the benefits of continued HRT outweigh the risks for your individual circumstances.

Side effects of Kliovance

Common side effects

Breast tenderness or discomfort is one of the most frequently reported side effects, particularly during the first few months. This usually diminishes with continued use.

Headache, abdominal bloating, nausea, and mood changes (including irritability or low mood) are also common. Some women experience fluid retention, mild weight fluctuation, or leg cramps.

Breakthrough bleeding or spotting may occur during the first 3 to 6 months; this is expected as the endometrium adjusts to the continuous progestogen.

Uncommon and rare side effects

Migraine or worsening of existing migraine has been reported. Gallbladder disease (gallstones and cholecystitis) is a recognised risk of oral HRT. Elevated liver function tests occur uncommonly.

Changes in glucose tolerance, alterations in lipid profiles, and skin changes (acne, rash, or pruritus) have been described. Rare effects include jaundice, pancreatitis, and exacerbation of porphyria.

Serious risks of combined HRT

Combined HRT is associated with a small absolute increase in the risk of breast cancer, venous thromboembolism (DVT and PE), and ischaemic stroke.

The additional breast cancer risk with combined HRT is estimated at approximately 4 extra cases per 1,000 women over 5 years of use starting from age 50.

The VTE risk is approximately doubled with oral HRT, though the absolute risk remains low (roughly 2 additional cases per 1,000 women per year).

The stroke risk is modestly elevated, particularly in women over 60.

These risks should be weighed against the benefits of symptom relief and bone protection, and they diminish after HRT is stopped.

There is no increased risk of coronary heart disease when combined HRT is started under the age of 60 or within 10 years of menopause. Starting HRT later than this window may increase cardiovascular risk rather than reduce it.

When to seek urgent medical advice

Contact your GP or call NHS 111 if you develop persistent headache, breast lumps, prolonged or heavy vaginal bleeding after the initial settling-in period, or mood changes that concern you.

Call 999 or attend A&E if you experience sudden chest pain, breathlessness, leg swelling or pain suggestive of a deep vein thrombosis, signs of a stroke (facial drooping, arm weakness, speech difficulty), or a severe allergic reaction.

Report any suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Contraindications

Kliovance must not be used in women with known or suspected breast cancer, other oestrogen-dependent malignancies, undiagnosed abnormal genital bleeding, untreated endometrial hyperplasia, active or recent venous or arterial thromboembolism, active liver disease or a history of liver disease with persistently abnormal liver function tests, known thrombophilic disorders, porphyria, or known hypersensitivity to any component of the tablet.

Special precautions

Conditions requiring careful assessment before and during HRT use include a history of endometrial hyperplasia, fibroids, endometriosis, risk factors for oestrogen-dependent tumours, risk factors for thromboembolism, hypertension, diabetes, migraine, epilepsy, asthma, otosclerosis, systemic lupus erythematosus, and a history of gallbladder disease.

Close clinical monitoring is recommended if any of these conditions are present.

Drug interactions

Enzyme-inducing drugs (carbamazepine, phenytoin, phenobarbital, rifampicin, and certain antiretrovirals) may reduce the efficacy of Kliovance by increasing the metabolism of estradiol.

St John's wort may also reduce oestrogen levels. Lamotrigine levels may be affected by HRT, and dose adjustments may be needed.

Inform your prescriber of all medicines you are taking.

How to get Kliovance in the UK

Kliovance is a prescription-only medicine available through the NHS.

Your GP, a menopause specialist, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC) can prescribe it after an appropriate clinical assessment.

The standard NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

An annual HRT prepayment certificate may be cost-effective for women using multiple HRT prescriptions.

Living well during and after the menopause

HRT is one part of a broader approach to menopausal health. NICE recommends combining pharmacological treatment with lifestyle measures.

Regular weight-bearing and resistance exercise helps maintain bone density and cardiovascular fitness. A balanced diet rich in calcium and vitamin D supports bone health.

Limiting alcohol to no more than 14 units per week, stopping smoking, and managing stress all contribute to overall wellbeing.

Cognitive behavioural therapy (CBT) has evidence of benefit for menopausal mood symptoms and sleep disturbance and can be used alongside or instead of HRT.

Peer support groups and reliable information sources, such as the NHS website and the British Menopause Society, can help women make informed decisions about their menopausal care.

Sources

• Kliovance, Summary of Product Characteristics (EMC)
• Norethisterone, British National Formulary (BNF)
• NICE NG23: Menopause, diagnosis and management
• Hormone replacement therapy (HRT), NHS
• British Menopause Society
• MHRA Yellow Card Scheme