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Oestrogen (Hormone Replacement Therapy)

Estradiol (HRT)

Brand names: Estradot (patch), Oestrogel (gel), Elleste Solo (tablet), Evorel (patch)

Estradiol (HRT) is natural oestrogen used as hormone replacement therapy to relieve menopausal symptoms such as vasomotor flushes and urogenital atrophy.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 1 mg estradiol once daily by mouth (one Elleste Solo 1 mg tablet) — ORAL TABLET ROUTE ONLY
Route: Oral. SPC §4.2 verbatim: 'Method of administration For oral use.' ⚠️ SCOPE: the figure above covers the oral tablet presentation only. The transdermal patch and transdermal gel doses shown on this page are NOT sourced by this bundle and are not asserted here.
Frequency: Once daily. SPC §4.2 verbatim: 'One tablet daily to be taken orally.' and 'Elleste Solo 1 mg may be taken continuously in hysterectomised women.'
INDICATION (matches this page): 'For initiation and continuation of treatment of post-and peri-menopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4) should be used.' STRENGTH PINNED BY THE SOURCE (§4.2 verbatim): 'Elleste Solo tablets are available in two strengths: Elleste Solo 1 mg (containing 1 mg estradiol) and Elleste Solo 2 mg (containing 2 mg estradiol).' The fetched SPC is the 1 mg product and its posology is one tablet daily, so 1 mg once daily is the figure published; the 2 mg strength is recorded here but is NOT asserted as a titration step, because this SPC gives no instruction to increase from 1 mg to 2 mg. The 2 mg strength carries an EXTRA indication (verbatim): 'Elleste Solo 2 mg is additionally indicated for prevention of osteoporosis in postmenopausal women at high risk of future fractures and who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.' NO MAXIMUM DOSE is stated anywhere in the fetched SPC — there is no 'maximum'/'up to' ceiling cue in §4.2 — so maxDose is deliberately left empty rather than inferred from the 2 mg strength. PROGESTOGEN OPPOSITION (verbatim): 'In women with a uterus, a progestogen should be added for 12 - 14 days each cycle to oppose the production of an oestrogen-stimulated hyperplasia of the endometrium. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.' WHEN TO START (verbatim): 'Therapy may start at any time in women with established amenorrhoea or who are experiencing long intervals between spontaneous menses. In patients who are menstruating, it is advised that therapy starts on the first day of bleeding. Patients changing from a cyclical or continuous sequential preparation should complete the cycle and may then change to Elleste Solo 1 mg without a break in therapy. Patients changing from a continuous combined preparation may start therapy at any time if amenorrhoea is established, or otherwise start on the first day of bleeding.' MISSED/EXTRA TABLET (verbatim): 'If a tablet is missed it should be taken within 12 hours of when normally taken; otherwise the tablet should be discarded, and the usual tablet should be taken the following day. A missed dose may lead to break-through bleeding or spotting in non-hysterectomised women. If one extra tablet is taken inadvertently, the usual tablet should be taken the following day.' ELDERLY (verbatim): 'There are no special dosage requirements for elderly patients.' PAEDIATRIC (verbatim): 'Not to be used in children.' — hence paedDose is null.

Dose adjustments

Renal

Not stated — no renal-impairment dosing statement appears in any fetched section of this SPC. §4.2 'Special populations' addresses only the elderly ('There are no special dosage requirements for elderly patients') and the paediatric population ('Not to be used in children').

Hepatic

No dose adjustment is given; the SPC instead makes liver disease a CONTRAINDICATION (§4.3 verbatim): 'Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal.' §4.4 lists 'Liver disorders (e.g. liver adenoma)' among conditions requiring close supervision, and gives 'Jaundice or deterioration in liver function' as a reason for immediate withdrawal of therapy.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Known, past or suspected breast cancer (§4.3)
  • Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer) (§4.3)
  • Undiagnosed genital bleeding (§4.3)
  • Untreated endometrial hyperplasia (§4.3)
  • Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) (§4.3)
  • Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency) (§4.3)
  • Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) (§4.3)
  • Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal (§4.3)
  • Known hypersensitivity to the active substances or to any of the excipients listed in Section 6.1 (§4.3)
  • Porphyria (§4.3)

Side effects

  • Reproductive system and breast disorders (§4.8): metrorrhagia, breast tenderness, breast enlargement, uterine/vaginal bleeding including spotting, breast pain, dysmenorrhoea, vaginal discharge, premenstrual syndrome, fibrocystic breast disease
  • Gastrointestinal disorders (§4.8): nausea, abdominal pain, dyspepsia, vomiting, flatulence, gastroesophageal reflux disease; pancreatitis in women with pre-existing hypertriglyceridaemia
  • Nervous system disorders (§4.8): headache, dizziness, migraine; probable dementia over the age of 65, chorea, exacerbation of epilepsy
  • Hepatobiliary disorders (§4.8): gallbladder disorder, cholelithiasis, hepatic function abnormal — sometimes with jaundice
  • Vascular and cardiac disorders (§4.8): venous thromboembolism (deep leg or pelvic venous thrombosis and pulmonary embolism), stroke, arterial thromboembolism (angina and myocardial infarction), palpitations
  • Neoplasms (§4.8): breast cancer; oestrogen-dependent neoplasms benign and malignant, e.g. endometrial cancer, ovarian cancer; increase in size of leiomyoma
  • Skin and subcutaneous tissue disorders (§4.8): rash, pruritus, erythema nodosum, urticaria, hirsutism, acne, angioedema, erythema multiforme, vascular purpura, chloasma
  • Psychiatric disorders (§4.8): mood alterations including anxiety and depressed mood, libido disorder
  • Metabolism and nutrition (§4.8): weight increased, weight decreased. Infections: vaginal candidiasis. Immune: hypersensitivity. Eye: visual disturbances, contact lens intolerance. Musculoskeletal: muscle cramps. General: oedema. Renal and urinary: urinary incontinence
  • Breast cancer risk quantification (§4.8 verbatim): 'An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestogen therapy for more than 5 years. The increased risk in users of oestrogen-only therapy is lower than that seen in users of oestrogen-progestogen combinations. The level of risk is dependent on the duration of use.'
  • ⚠️ Frequency categories are NOT asserted per item: the §4.8 frequency table was flattened during the source fetch and truncated part-way through the breast-cancer risk tables, so the column each term belonged to (common / uncommon / rare / frequency unknown) cannot be reconstructed reliably. Check frequencies against the SPC itself.

Monitoring

  • §4.4 verbatim: 'In all cases a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.'
  • §4.4 verbatim: 'Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use.'
  • §4.4 verbatim: 'During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.'
  • §4.4 verbatim: 'Investigations, including mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.'
  • §4.4 verbatim: 'Women should be advised what changes in their breasts should be reported to their doctor or nurse.'
  • Close supervision if present, previously occurred, or aggravated in pregnancy/previous hormone treatment (§4.4): leiomyoma (uterine fibroids) or endometriosis; risk factors for thromboembolic disorders; risk factors for oestrogen-dependent tumours (e.g. first-degree heredity for breast cancer); hypertension; liver disorders; diabetes mellitus with or without vascular involvement; cholelithiasis; migraine or severe headache; systemic lupus erythematosus; a history of endometrial hyperplasia; epilepsy; asthma; otosclerosis
  • Immediate withdrawal of therapy (§4.4 verbatim): 'Jaundice or deterioration in liver function; Significant increase in blood pressure; New onset of migraine-type headache; Pregnancy.'
  • Endometrial safety (§4.4): in women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are given alone for prolonged periods; 'After stopping treatment, risk may remain elevated for at least 10 years.'

Clinical monograph

How it works

Activates oestrogen receptors to replace declining endogenous oestrogen, easing vasomotor and urogenital symptoms and supporting bone density.

Prescribing in practice

  • Unopposed systemic oestrogen must be avoided in women with a uterus; pair it with a progestogen to protect the endometrium.
  • Choose the transdermal route preferentially where venous thromboembolism risk is a concern, as it avoids the first-pass increase in clotting risk.
  • Individualise the decision around breast cancer, stroke and thrombosis risk and review at least annually.

Monitoring

Reassess symptoms, blood pressure and treatment benefit-risk at least annually, and investigate unscheduled bleeding promptly.

Counselling the patient

  • Seek advice for unexpected bleeding, breast changes, or symptoms suggesting a clot.
  • Continue breast and cervical screening when invited.
  • Take any accompanying progestogen exactly as prescribed if you still have a womb.

Evidence & guidelines

NICE menopause guidance supports hormone replacement therapy for menopausal symptom relief with individualised risk assessment.

Reference: WHI trial (Rossouw et al. JAMA 2002); Million Women Study (Lancet 2003); MHRA HRT Update 2023; NICE NG23 (Menopause 2015, updated 2024); SPC Estradot; Collaborative MNSG Lancet 2019; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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