Elleste Solo

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Elleste Solo on Prescriptsy

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Elleste Solo is an oestrogen-only hormone replacement therapy (HRT) tablet containing estradiol, the most potent naturally occurring oestrogen in women.

Manufactured by Viatris (formerly Mylan), it is licensed in the United Kingdom for the relief of oestrogen-deficiency symptoms associated with the menopause and for the prevention of postmenopausal osteoporosis in women at increased risk of fractures who cannot tolerate or have contraindications to other osteoporosis treatments.

Elleste Solo is available in 1 mg and 2 mg tablet strengths, allowing dose adjustment based on symptom severity and individual response.

The menopause affects all women, typically occurring between the ages of 45 and 55 in the UK, with the average age of onset at 51.

Approximately 75 to 80% of women experience menopausal symptoms, and around 25% describe them as severe enough to significantly impair daily functioning, work performance, relationships, and overall quality of life.

HRT remains the most effective treatment for vasomotor symptoms and is recommended by NICE Guideline NG23 as a first-line option for the management of menopausal symptoms.

This page provides a comprehensive clinical overview of Elleste Solo, including how it works, dosing guidance, the importance of progestogen co-prescription, side effects, safety warnings, and how to obtain a prescription in the UK.

Important safety information about Elleste Solo

Before reading further, note the following key safety points about Elleste Solo.

• Women with an intact uterus must not take Elleste Solo without concurrent progestogen therapy. Unopposed oestrogen significantly increases the risk of endometrial hyperplasia and endometrial cancer.
• Oral oestrogen HRT is associated with a small increased risk of venous thromboembolism and ischaemic stroke. Transdermal alternatives (patches or gel) carry lower thrombotic risk and should be considered for women with additional risk factors.
• The risk of breast cancer is modestly increased with long-term combined HRT. For oestrogen-only HRT, the risk is lower and may not be significantly elevated for the first 5 to 7 years of use.
• HRT should be prescribed at the lowest effective dose for the shortest time necessary to control symptoms, with at least annual review.

Understanding the menopause

The menopause is defined as the permanent cessation of menstruation resulting from the loss of ovarian follicular activity.

It is confirmed retrospectively after 12 consecutive months of amenorrhoea in the absence of other pathological or physiological causes.

The perimenopause (menopausal transition) is the period of hormonal fluctuation leading up to the final menstrual period, during which symptoms typically begin.

Postmenopause refers to the years following the last menstrual period.

During the menopausal transition, ovarian production of estradiol declines progressively and erratically. This hormonal decline triggers a cascade of physiological changes.

The hypothalamus, which acts as the body's thermoregulatory centre, becomes more sensitive to small changes in core temperature, leading to vasomotor instability manifest as hot flushes and night sweats.

Genitourinary tissues, which are oestrogen-dependent, undergo atrophic changes causing vaginal dryness, dyspareunia (painful intercourse), urinary frequency, and recurrent urinary tract infections.

Bone remodelling shifts toward net resorption, accelerating bone mineral density loss and increasing fracture risk. Mood, cognition, and sleep may also be affected.

Menopause in the UK

According to the Office for National Statistics and Menopause Mandate data, there are approximately 13 million perimenopausal and postmenopausal women in the UK.

NICE NG23 and the British Menopause Society (BMS) emphasise that menopausal symptoms should be taken seriously and that effective treatments are available.

The 2015 NICE guideline on menopause was a landmark publication that helped shift clinical and societal attitudes, encouraging women to seek help and healthcare professionals to offer evidence-based treatment rather than dismissing symptoms as an inevitable consequence of ageing.

How Elleste Solo works: mechanism of action

Estradiol (17-beta-estradiol) is the principal and most biologically active oestrogen produced by the human ovary.

It exerts its effects by binding to intracellular oestrogen receptors (ERalpha and ERbeta), which function as ligand-activated transcription factors.

Upon binding estradiol, the receptor undergoes a conformational change, dimerises, and translocates to the nucleus, where it binds to oestrogen response elements (EREs) in the promoter regions of target genes.

This modulates the transcription of hundreds of genes involved in cell proliferation, differentiation, metabolism, and apoptosis across multiple organ systems.

In the context of menopausal HRT, exogenous estradiol supplements the declining endogenous supply and restores oestrogenic activity in target tissues.

In the hypothalamus, estradiol stabilises the thermoregulatory centre, reducing the frequency and severity of hot flushes and night sweats.

In the genitourinary tract, it reverses vaginal atrophy by stimulating epithelial proliferation, increasing glycogen deposition, restoring vaginal pH, and improving blood flow.

In bone, estradiol inhibits osteoclast-mediated resorption and promotes osteoblast activity, slowing or reversing postmenopausal bone loss.

Elleste Solo tablets contain micronised estradiol, which undergoes first-pass hepatic metabolism after oral absorption.

The major circulating metabolites are estrone and estrone sulphate, which serve as a circulating reservoir and are converted back to estradiol in peripheral tissues.

The oral route of administration has implications for hepatic protein synthesis, including increased production of clotting factors, sex hormone-binding globulin (SHBG), and triglycerides.

These hepatic effects underlie some of the differences in risk profile between oral and transdermal HRT preparations.

Clinical evidence and national guidelines

NICE Guideline NG23: Menopause

NICE NG23, published in 2015 and updated in 2019, provides the primary clinical framework for the management of menopause in the UK. Key recommendations include the following.

HRT should be offered as first-line treatment for vasomotor symptoms after a discussion of the short-term and long-term benefits and risks.

Oestrogen-only HRT is recommended for women who have had a hysterectomy. Combined HRT (oestrogen plus progestogen) is recommended for women with an intact uterus.

Transdermal HRT should be considered for women at increased risk of VTE. HRT can be started without routine blood tests in women over 45 with typical menopausal symptoms.

CBT and isoflavones are noted as possible non-hormonal alternatives, but HRT remains the most effective treatment for vasomotor symptoms.

British Menopause Society guidance

The BMS endorses the recommendations of NICE NG23 and provides additional practical guidance for clinicians.

The BMS emphasises that for women under 60 who start HRT within 10 years of the menopause, the benefits generally outweigh the risks.

The BMS also highlights that HRT should not be withheld solely because of concerns about breast cancer risk, as the absolute risk is small and must be contextualised against the significant quality-of-life benefits for symptomatic women.

Evidence on symptom relief

Systematic reviews and meta-analyses consistently demonstrate that oestrogen-based HRT is the most effective treatment for vasomotor symptoms, reducing the frequency and severity of hot flushes by approximately 75% compared with placebo.

A Cochrane review confirmed that oral and transdermal estradiol are both effective for the relief of vasomotor symptoms, with the choice of route influenced by individual risk factors and patient preference.

Oestrogen therapy also significantly improves vaginal dryness, dyspareunia, and urogenital symptoms of menopause.

The role of progestogen in HRT

Oestrogen stimulates proliferation of the endometrium.

In women with an intact uterus, unopposed oestrogen therapy significantly increases the risk of endometrial hyperplasia (abnormal thickening of the womb lining) and endometrial cancer.

The addition of a progestogen for at least 12 to 14 days per 28-day cycle (sequential regimen) or continuously (continuous combined regimen) opposes the proliferative effect of oestrogen and reduces the endometrial risk to below that of untreated women.

Common progestogens prescribed alongside Elleste Solo include medroxyprogesterone acetate (MPA), norethisterone, dydrogesterone, and micronised progesterone (Utrogestan).

Micronised progesterone has a more favourable side-effect profile and may be associated with a lower breast cancer risk than synthetic progestogens.

Your prescriber will advise on the most appropriate progestogen based on your medical history, bleeding pattern, and preferences.

Women who have had a hysterectomy do not have endometrial tissue and therefore do not require progestogen supplementation. Elleste Solo can be prescribed as a standalone treatment in this group.

Dosage and administration

Elleste Solo is available in two strengths: 1 mg and 2 mg estradiol tablets. Treatment should be started at the lowest effective dose and adjusted based on symptom response.

Starting treatment

For women who are still having periods (perimenopausal), Elleste Solo is usually started on the first day of menstrual bleeding.

For women who are postmenopausal and not taking another HRT product, treatment can begin on any convenient day.

Women switching from a different HRT preparation should follow the guidance provided by their prescriber regarding the transition.

Dose adjustment

If menopausal symptoms are not adequately controlled after 4 to 8 weeks on the 1 mg dose, the prescriber may increase the dose to 2 mg daily.

Conversely, if symptoms are well controlled on the 2 mg dose, a trial of dose reduction to 1 mg may be appropriate to minimise oestrogen exposure.

The goal is to use the lowest dose that provides adequate symptom relief.

Duration of treatment

There is no arbitrary maximum duration for HRT. NICE NG23 recommends reviewing the need for treatment at least annually, discussing the ongoing benefits and any evolving risks.

For many women, the benefits of continued HRT outweigh the risks for 5 years or more.

Some women may choose to continue HRT long-term after informed discussion with their prescriber.

Gradual dose reduction may help identify whether symptoms have resolved, but there is no requirement to taper rather than stop abruptly.

Side effects of Elleste Solo

Common side effects

The most frequently reported side effects of oral estradiol include breast tenderness or swelling, headache, nausea, abdominal bloating and discomfort, and irregular vaginal bleeding or spotting during the first few months of treatment.

These effects are often transient and improve with continued use. If breast tenderness is troublesome, reducing the dose may help.

Uncommon side effects

Fluid retention, weight fluctuation, mood changes (including low mood and irritability), migraine or worsening of existing migraine, leg cramps, skin rash, pruritus, and changes in vaginal discharge may occur.

Alterations in liver function tests, gallstone formation, and changes in lipid profiles have been reported with oral oestrogen therapy.

Rare but serious side effects

Venous thromboembolism (deep vein thrombosis and pulmonary embolism) is the most clinically significant vascular risk associated with oral HRT.

The relative risk is approximately 1.5 to 3 times that of non-users, with the highest risk during the first year of treatment.

The absolute risk remains low, particularly in women under 60: approximately 1 to 2 additional cases per 1,000 women per year.

Transdermal oestrogen does not appear to increase VTE risk and is recommended for women with additional risk factors.

Ischaemic stroke risk is slightly elevated with oral oestrogen, particularly in women over 60.

There is a small increased risk of ovarian cancer with long-term HRT use (more than 5 years).

Breast cancer risk

The relationship between HRT and breast cancer risk is nuanced.

For oestrogen-only HRT in women who have had a hysterectomy, the Women's Health Initiative (WHI) trial showed no statistically significant increase in breast cancer risk during approximately 7 years of use, and a subsequent follow-up suggested a possible reduction.

For combined HRT (oestrogen plus progestogen), the risk of breast cancer increases modestly with duration of use beyond 5 years.

The absolute excess risk attributable to combined HRT is approximately 4 to 5 additional cases per 1,000 women over 5 years.

This risk should be weighed against the substantial quality-of-life benefits and the reduction in other health risks such as osteoporotic fractures.

When to seek urgent medical advice

Seek emergency help by calling 999 if you experience sudden severe chest pain, sudden breathlessness, painful swelling of one calf, sudden severe headache, sudden visual disturbance, facial drooping, arm weakness, or speech difficulty.

These may be signs of a blood clot, pulmonary embolism, or stroke.

Contact your GP or NHS 111 for persistent headaches, breast lumps, unexplained vaginal bleeding after the first few months of treatment, or any symptoms that concern you.

Warnings and precautions

Endometrial protection

Women with an intact uterus must take a progestogen alongside Elleste Solo.

Unopposed oestrogen use for more than one year increases the risk of endometrial cancer by 2 to 12 times compared with non-users.

The addition of adequate progestogen eliminates this excess risk.

Any unscheduled vaginal bleeding after the first 6 months of treatment, or any bleeding that persists beyond the expected withdrawal bleed in a sequential regimen, should be investigated to exclude endometrial pathology.

Venous thromboembolism

Oral oestrogen HRT increases VTE risk, particularly during the first year and in women with additional risk factors (obesity, immobilisation, previous VTE, thrombophilia, older age).

Transdermal oestrogen (patches or gel) does not appear to increase VTE risk and should be preferentially prescribed for women with a BMI over 30 or other VTE risk factors.

Elleste Solo should be stopped at least 4 to 6 weeks before major elective surgery or prolonged immobilisation.

Cardiovascular disease

The cardiovascular effects of HRT depend on the timing of initiation relative to menopause onset.

The WHI and subsequent analyses support the "timing hypothesis": women who start HRT within 10 years of the menopause or before age 60 may derive cardiovascular benefit, while those who start later face a net increase in cardiovascular risk.

NICE NG23 acknowledges this evidence and advises that HRT should not be withheld for cardiovascular reasons in women under 60.

Breast screening

Women taking HRT should attend all scheduled NHS Breast Screening Programme appointments (every 3 years for women aged 50 to 71 in England).

HRT may increase mammographic breast density, which can make mammograms harder to interpret and may reduce the sensitivity of screening.

Any new breast lump, skin change, or nipple discharge should be reported promptly to a GP.

How to get an Elleste Solo prescription in the UK

Elleste Solo is a prescription-only medicine (POM) in the UK.

Prescriptions can be obtained from your GP, a specialist menopause clinic, or an authorised online prescriber registered with the GPhC.

Before prescribing, the clinician will review your symptoms, medical history, cardiovascular and thrombotic risk factors, breast screening status, and current medications.

NICE NG23 recommends that women over 45 with typical menopausal symptoms can be diagnosed and treated without routine blood tests.

The standard NHS prescription charge in England is currently 9.90 pounds per item. A prepayment certificate (PPC) may be cost-effective for women taking multiple HRT prescriptions.

Prescriptions are free for all patients in Scotland, Wales, and Northern Ireland.

The NHS HRT prepayment certificate, introduced in 2023, allows women in England to pay a single annual charge to cover all their HRT prescriptions for 12 months.

Living with menopause: practical management

In addition to HRT, the following strategies can help manage menopausal symptoms and maintain long-term health.

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

Limiting caffeine and alcohol intake, particularly in the evening, may reduce hot flushes and improve sleep quality.

Wearing layered clothing and using a fan or cooling pillow can help manage hot flushes. Vaginal moisturisers and lubricants can supplement systemic HRT for genitourinary symptoms.

Cognitive behavioural therapy (CBT) has been shown to help with mood symptoms, sleep difficulties, and the impact of hot flushes. Pelvic floor exercises can help prevent urinary incontinence.

When to seek urgent medical advice

Seek emergency medical help by calling 999 if you experience sudden severe chest pain, sudden breathlessness, a painful swollen leg, sudden severe headache, sudden loss of vision, facial drooping, arm weakness, or slurred speech.

These may be signs of a blood clot, pulmonary embolism, or stroke. For non-urgent concerns, contact your GP or NHS 111.

Report any suspected adverse reactions to Elleste Solo via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Sources

• Elleste Solo 1 mg tablets, Summary of Product Characteristics (EMC)
• Estradiol, British National Formulary (BNF)
• NICE NG23: Menopause: diagnosis and management
• British Menopause Society practice guidance
• Hormone replacement therapy (HRT), NHS
• MHRA Yellow Card Scheme