Combined HRT (oestrogen + progestogen) Pregnancy: §4.6: not indicated during pregnancy. If pregnancy occurs during treatment, withdraw immediately. Data on a limited number of exposed pregnancies indicate no adverse effects of norethisterone acetate on the foetus; at doses higher than normally used in oral contraceptive and HRT formulations, masculinisation of female foetuses was observed. Most epidemiological studies relevant to inadvertent foetal exposure to combinations of oestrogens and progestogens indicate no teratogenic or foetotoxic effect. Not indicated during breast-feeding.

Estradiol with norethisterone

Brand names: Kliovance, Novofem, Elleste Duet, Evorel Conti, Evorel Sequi

A combination of estradiol (oestrogen) with norethisterone (a progestogen) used most commonly as a continuous or sequential hormone replacement therapy preparation for menopausal symptoms in women with a uterus.

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: One white tablet daily for the first 16 days, then one pale green tablet for the next 12 days (Elleste Duet 1 mg — 1 mg estradiol and 1 mg norethisterone acetate)

Route: Oral

Frequency: Once daily on a 28-day cycle — a new cycle then begins without any break

SOURCE PRODUCT: Elleste Duet 1 mg tablets — a continuous sequential HRT. STRENGTHS: Elleste Duet 1 mg contains 1 mg estradiol and 1 mg norethisterone acetate; Elleste Duet 2 mg contains 2 mg estradiol and 1 mg norethisterone acetate. Elleste Duet 2 mg is additionally indicated for prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. For initiation and continuation of treatment of post- and peri-menopausal symptoms the lowest effective dose for the shortest duration should be used. STARTING: therapy may start at any time in patients with established amenorrhoea or 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 another cyclical or continuous sequential preparation should complete the cycle and may then change without a break in therapy; patients changing from a continuous combined preparation may start at any time if amenorrhoea is established, otherwise on the first day of bleeding. MISSED TABLET: take within 12 hours of the usual time, otherwise discard it and take the usual tablet the following day — a missed tablet increases the likelihood of breakthrough bleeding or spotting. ELDERLY: there are no special dosage requirements. PAEDIATRIC: not to be used in children.

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

Side effects

Breast pain and tenderness, breast enlargement (common to uncommon) — among the most commonly reported effects
Dysmenorrhoea, menstrual disorder, irregular vaginal bleeding, menorrhagia, genital discharge, uterine spasms, vaginal infection and endometrial hyperplasia
Headache (common); dizziness and insomnia (common); migraine and vertigo (uncommon); paraesthesia (rare)
Nausea, abdominal distension, diarrhoea, dyspepsia and abdominal pain (common); vomiting (uncommon)
Hypertension and varicose veins (uncommon); venous embolism and thrombophlebitis (rare)
Gallbladder disorder and cholelithiasis (uncommon); cholestatic jaundice (rare); acne, rash, pruritus and dry skin (common to uncommon); weight increased and peripheral oedema

Clinical monograph

How it works

Estradiol replaces declining endogenous oestrogen to relieve vasomotor and urogenital symptoms, while norethisterone provides endometrial protection by opposing oestrogen-driven endometrial proliferation.

Prescribing in practice

HRT is associated with a small increased risk of venous thromboembolism, stroke and breast cancer; discuss individualised benefit-risk and use the lowest effective dose for the shortest appropriate duration.
The progestogen component is essential in women with an intact uterus to prevent endometrial hyperplasia and carcinoma.
Investigate any unscheduled or persistent bleeding, particularly after the initial settling period.

Monitoring

Review symptom control, bleeding pattern, blood pressure and ongoing benefit-risk at least annually.

Counselling the patient

Report any unexpected vaginal bleeding to your clinician.
Continue breast and cervical screening as recommended for your age.
Seek urgent advice for signs of clot such as leg swelling, chest pain or breathlessness.

Evidence & guidelines

NICE NG23 guides menopause management and the individualised discussion of HRT benefits and risks.

Reference: NICE NG23; British Menopause Society; 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

FAST Exam Protocol — Focused Assessment with Sonography in Trauma · Trauma

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