Prescribing HRT: A Clinical Guide for UK Independent Prescribers
Key Guidelines
- NICE NG23 (Menopause: diagnosis and management, updated 2023) — primary reference
- British Menopause Society (BMS) consensus statements and tools
- MHRA product-specific guidance
Diagnosis of Menopause / Perimenopause
Clinical Diagnosis
In women aged ≥45 years with typical symptoms, menopause is a clinical diagnosis — no blood tests are needed for diagnosis, per NICE NG23.
Symptoms suggestive of menopause/perimenopause:
- Irregular/absent periods
- Vasomotor symptoms (hot flushes, night sweats)
- Psychological symptoms (mood, cognition, sleep)
- Genitourinary symptoms (GSM)
- Musculoskeletal symptoms
When Blood Tests Are Indicated
| Scenario | Test | Rationale |
|---|
| Age <45 years | FSH, LH, oestradiol | To confirm premature ovarian insufficiency (POI) |
| Hysterectomy / no periods (any age) | FSH | Confirm menopause if diagnostic uncertainty |
| Testosterone consideration | Total testosterone, SHBG | Baseline before prescribing |
FSH is unreliable during perimenopause due to fluctuation. A single normal FSH does not exclude perimenopause.
HRT Formulary — Prescribing Choices
Oestrogen Formulations
Transdermal (preferred over oral — lower VTE, stroke risk):
| Product | Formulation | Dose Range |
|---|
| Oestrogel 0.06% | Pump gel | 1–4 pumps (0.75–3mg E2) daily |
| Sandrena 0.1% | Sachet gel | 0.5–1.5mg daily |
| Lenzetto 1.53mg | Spray | 1–3 sprays daily |
| Evorel 25/50/75/100 | Patch | 25–100mcg/24h, change twice weekly |
| Estradot 25–100 | Patch | 25–100mcg/24h, change twice weekly |
| Product | Dose |
|---|
| Zumenon 1mg / 2mg | 1–2mg daily |
| Elleste Solo 1mg / 2mg | 1–2mg daily |
- Transdermal gel: 2 pumps Oestrogel (1.5mg E2) daily
- Transdermal patch: Evorel 50 (50mcg/24h)
- Oral: Zumenon 2mg / Elleste Solo 2mg daily
Progestogen Formulations
For endometrial protection — all women with intact uterus require progestogen.
Micronised Progesterone (Body-Identical — preferred)
| Product | Dose |
|---|
| Utrogestan 100mg / 200mg capsules (oral or vaginal) | Sequential: 200mg for 12 days/cycle. Continuous: 100mg daily |
Lowest breast cancer risk signal among progestogens; lower cardiovascular risk; improves sleep (neurosteroid effect).
Consideration: Oral use — take at night (sedating). Vaginal use: less sedation, good for women with GI side effects.
Synthetic Progestogens
| Product | Type | Notes |
|---|
| Norethisterone (in Evorel Sequi, Trisequens) | Nortestosterone derivative | Effective; may worsen mood in some women |
| Levonorgestrel IUS (Mirena) | Delivers progestogen locally to uterus | Excellent endometrial protection; systemic absorption minimal; licensed for HRT endometrial protection |
| Medroxyprogesterone acetate (Provera) | Pregnane derivative | Older agent; breast cancer risk signal higher |
| Dydrogesterone (Femoston) | Retroprogesterone | Closer to natural progesterone; lower androgenic activity |
Pre-Combined Products (Convenience)
Sequential:
| Product | Oestrogen | Progestogen |
|---|
| Evorel Sequi | E2 50mcg (patch) | Norethisterone 170mcg patch |
| Femoston 1/10, 2/10 | E2 1mg or 2mg (tablet) | Dydrogesterone 10mg (tablet) for 14 days |
| Elleste Duet 1mg / 2mg | E2 1mg or 2mg | Norethisterone |
| Product | Oestrogen | Progestogen |
|---|
| Evorel Conti | E2 50mcg patch | Norethisterone 170mcg patch |
| Femoston-Conti 1mg/5mg | E2 1mg | Dydrogesterone 5mg |
| Kliofem | E2 2mg | Norethisterone acetate |
Local / Vaginal Oestrogen
For GSM — safe in almost all women including breast cancer survivors (with oncologist input for higher-risk cases). Monitor annually; no systemic HRT risk profile.
| Product | Type | Dose |
|---|
| Vagifem / Vagirux 10mcg pessary | Pessary | 1 pessary daily for 2 weeks, then 2x/week |
| Estring 2mg | Intravaginal ring | Replace every 90 days |
| Ovestin 0.1% cream | Cream | Small amount daily for 2 weeks, then 2x/week |
| Imvaggis 0.03mg | Pessary | 1 pessary daily for 2 weeks, then 2x/week |
Testosterone for Women
Off-label in the UK (no licensed product for women). Supported by BMS guidelines for low libido unresponsive to optimised HRT.
- Testogel 16.2mg/g: 2.5–5mg daily (approx 0.15–0.3ml of gel)
- Apply to thigh — avoid high-absorption areas (inner thigh)
- Monitor total testosterone at 3 months (aim female physiological range: 0.3–1.8 nmol/L; do NOT use male range)
- Monitor for androgenic side effects (acne, hair, clitoromegaly)
- Ensure oestrogen levels are adequate before adding testosterone
Contraindications
Absolute Contraindications to Systemic HRT
- Oestrogen-receptor positive breast cancer (active or recent — liaise with oncology)
- Undiagnosed vaginal bleeding (investigate first)
- Untreated endometrial cancer
- Active VTE unless therapeutic anticoagulated (specialist decision)
- Active severe liver disease with abnormal LFTs
Relative Contraindications (Individual Risk-Benefit Assessment)
- Previous VTE (provoked) — transdermal oestrogen generally safe
- Fibroid uterus — monitor; may enlarge on HRT
- Personal history of breast cancer — may consider vaginal oestrogen only; liaise with oncology
- Migraine with aura — oral oestrogen avoided; transdermal generally acceptable
- Hypertriglyceridaemia — oral oestrogen contraindicated (worsens triglycerides); transdermal safe
Risk Communication and Documentation
VTE Risk Stratification
| Route | VTE Risk |
|---|
| Oral oestrogen | RR ~2x background (absolute risk small: ~2/1000 over 5 yrs) |
| Transdermal oestrogen | No increased risk — use transdermal for women with any VTE risk factors |
obesity (BMI >30), personal/family history VTE, thrombophilia (check Factor V Leiden, antiphospholipid antibodies if relevant), prolonged immobility.
Breast Cancer Risk Communication
Use validated tool: PREDICT Menopause or discuss absolute risks using BMS consensus figures:
- 5 years sequential combined HRT: ~4 extra cases/1000 women vs 23/1000 background risk
- 5 years continuous combined HRT: ~6 extra cases/1000
- Body-identical progesterone (Utrogestan) appears to carry the lowest risk in this category
Document that breast cancer risk has been discussed, quantified, and patient informed.
Monitoring Schedule
| Timepoint | Action |
|---|
| Baseline | BP, weight, FH of breast/endometrial/CVD, symptom assessment |
| 3 months | Symptom response, side effects, compliance, dose adjustment |
| 12 months | BP, breast examination, cervical screening check, symptom review, uterine bleeding pattern |
| Annually | Full review; benefit-risk reassessment; mammogram reminder (NHS program) |
Unexpected bleeding (after 6 months of continuous combined HRT) requires investigation (TVUS, pipelle biopsy referral).
Cervical and Breast Screening
- Ensure patients continue NHS Breast Screening (mammogram every 3 years, 50–70 years)
- Ensure up-to-date cervical smear
- Document breast awareness counselling
Prescribing in Special Populations
Premature Ovarian Insufficiency (POI — <40 years)
- HRT is treatment of necessity, not optional
- Higher doses often needed than standard menopause
- Continue until average age of natural menopause (51 years) at minimum
- NICE NG23 and BMS strongly recommend HRT for POI
Perimenopausal Women
- Sequential HRT first-line (maintains bleed, confirms ovulation suppression)
- Ensure contraception if not certain of infertility (HRT is not contraceptive)
- Can use POP or progestogen IUS alongside HRT for dual purpose
Women with Cardiovascular Disease
- Transdermal oestrogen preferred
- HRT should not be started within 6 months of MI/stroke (specialist decision)
Documentation Best Practice
Your consultation record should include:
- LMP and menstrual history; menopausal status
- Symptom assessment (MRS / Green Climacteric Scale recommended)
- Risk factors for VTE, breast cancer, CVD
- Contraindications excluded and documented
- HRT product chosen and rationale (especially if oral — document why transdermal not chosen)
- Risk discussion (VTE and breast cancer, at minimum) documented with patient consent
- Monitoring plan agreed
- Breast screening and cervical screening checked
Clinical Disclaimer: This guide is intended to support prescribing decisions and does not replace individual clinical judgement or the need to follow current NICE guidelines and BMS recommendations. Always prescribe in accordance with your competency, scope of practice, and available indemnity.