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This formulary page covers diagnosis and management of menopause following NICE guideline [NG23] Menopause: diagnosis and management.

The guidance aims to support in the diagnosis and management of menopause including people with premature ovarian insufficiency to support GPs so they can optimise their patient’s treatment choices with them.

Please expand the topics below to see more detail. There are several resources also under Resources below, some of these will be useful to use with patients, but they may also support you in CPD. The HRT formulary is linked, however specific detail is shared as treatment pathways in each of the further pages under transdermal, oral or topical options.

For formulary information on testosterone, see below accordion on this page

See the SPS supply availability page for current stocks

The British Menopause Society (BMS) have provided an HRT preparations and equivalent alternatives document which may be useful when switching preparations or switching to manage out of stock situations.

Long Term Benefits and Risks of HRT

Venous thromboembolism

•the risk of venous thromboembolism (VTE) is increased by oral HRT compared with baseline population risk

•the risk of VTE associated with HRT is greater for oral than transdermal preparations

•the risk associated with transdermal HRT given at standard therapeutic doses is no greater than baseline population risk.

•Consider transdermal rather than oral HRT for menopausal people who are at increased risk of VTE, including those with a BMI over 30 kg/m2

•Consider referring menopausal people at high risk of VTE to a haematologist for assessment before considering HRT.

Cardiovascular disease

•HRT does not increase cardiovascular disease risk when started under 60 years

•HRT does not affect the risk of dying from cardiovascular disease

•the presence of cardiovascular risk factors is not a contraindication to HRT as long as they are optimally managed

•HRT with oestrogen alone is associated with no, or reduced, risk of coronary heart disease

•HRT with oestrogen and progestogen is associated with little or no increase in the risk of coronary heart disease

•Explain that taking oral (but not transdermal) oestrogen is associated with a small increase in the risk of stroke and the baseline population risk of stroke in women aged under 60 years is very low.

Osteoporosis

Give advice on bone health and discuss these issues at review appointments.

Explain that the baseline population risk of fragility fracture for women around menopausal age in the UK is low and varies from one woman to another.

Explain to women that their risk of fragility fracture is decreased while taking HRT and that this benefit:

•is maintained during treatment but decreases once treatment stops

•may continue for longer in women who take HRT for longer.

Review patients for risk of osteoporosis and fragility fractures in line with NICE Clinical Knowledge Summary: Osteoporosis – Prevention of fragility fractures: Assessment. Check FRAX score and consider bisphosphonate treatment if indicated. See formulary chapter 6.6.

Ensure patients are taking vitamin D as self-care in line with [PH56] Vitamin D: supplement use in specific population groups and ensure adequate dietary intake of calcium.

Breast Cancer or High Risk of Breast Cancer

Offer menopausal women and people with, or at high risk of, breast cancer:

-information on all available treatment options

-information that the SSRIs paroxetine and fluoxetine should not be offered to people with breast cancer who are taking tamoxifen

-referral to a healthcare professional with expertise in menopause.

Breast cancer

Using the MHRA risk table, explain to people around the age of natural menopause that:

-the baseline risk of breast cancer for people around menopausal age varies from one person to another according to the presence of underlying risk factors

-HRT with oestrogen alone is associated with little or no change in the risk of breast cancer

-HRT with oestrogen and progestogen can be associated with an increase in the risk of breast cancer

-any increase in the risk of breast cancer is related to treatment duration and reduces after stopping HRT. Stop systemic hormone replacement therapy (HRT) in women who are diagnosed with breast cancer.

Do not offer HRT (including oestrogen/progestogen combination) routinely to women with menopausal symptoms and a history of breast cancer. In exceptional circumstances, offer HRT to women with severe menopausal symptoms and with whom the associated risks have been discussed (unlicensed HRT is contraindicated with a history of breast cancer).

Do not offer soy (isoflavone), red clover, black cohosh, vitamin E or magnetic devices to treat menopausal symptoms in people with breast cancer.

Breastfeeding and Menopause

See CCG webpage Breastfeeding and Medicines for more information on prescribing medicine in breastfeeding patients.

Breastfeeding and HRT – Oestrogen:

Breastfeeding and Oestrogen cream or pessary

Breastfeeding and HRT – Progesterone:

Mirena® 20 micrograms/24 hours intrauterine delivery system can be used as protection from endometrial hyperplasia during oestrogen replacement therapy. See SPC for detail on length of treatment. Mirena is effective for 5 years in the indication of contraception, but 4 years for the progesterone component of HRT.

Breastfeeding and Medication – The Menopause and Breastfeeding

Contraception and Menopause

See CCG contraception webpage

FSRH Clinical Guideline: Contraception for Women Aged over 40 Years

People with premature ovarian insufficiency will be offered sex steroid replacement with a choice of HRT or a combined hormonal contraceptive (CHC). CHC (unless contraindicated) has the added benefit of providing contraceptive cover to people with premature ovarian insufficiency.

For people with a uterus requiring protection from endometrial hyperplasia during oestrogen replacement therapy as well as contraception, Mirena® 20 micrograms/24 hours intrauterine delivery system can be used. See SPC for detail on length of treatment. Mirena is effective for 5 years in the indication of contraception, but 4 years for the progesterone component of HRT.

For people who are perimenopausal, or menopausal, see the FSRH guidance above.

Diagnosis of Menopause

Diagnose the following without laboratory tests in otherwise healthy women or people assigned female at birth (AFAB), aged over 45 years with menopausal symptoms:

-perimenopause based on vasomotor symptoms and irregular periods

-menopause in women and people AFAB who have not had a period for at least 12 months and are not using hormonal contraception

-menopause based on symptoms in women and people AFAB without a uterus.

Follow NICE guidance for further information

Consider using a FSH test to diagnose menopause only:

-in women aged 40 to 45 years with menopausal symptoms, including a change in their menstrual cycle

-in women aged under 40 years in whom menopause is suspected

Information and advice

-explain the stages of menopause

-common symptoms and diagnosis

-lifestyle changes and interventions that could help general health and wellbeing

-benefits and risks of treatments

-long-term health implications of menopause.

Education

Explain as well as changes in menstrual cycle, other symptoms may include:

-vasomotor symptoms (for example, hot flushes and sweats)

-musculoskeletal symptoms (for example, joint and muscle pain)

-effects on mood (for example, low mood)

-urogenital symptoms (for example, vaginal dryness)

-sexual difficulties (for example, low sexual desire).

Information on treatments

-hormonal, for example hormone replacement therapy (HRT). See formulary and above for further information.

-non-hormonal, for example clonidine

-non-pharmaceutical, for example cognitive behavioural therapy (CBT).

– Give information on contraception

Diagnosing Premature Ovarian Insufficiency

Diagnose premature ovarian insufficiency in women aged under 40 years based on:

  • menopausal symptoms, including no or infrequent periods (taking into account whether the woman has a uterus) and
  • elevated FSH levels on 2 blood samples taken 4–6 weeks apart.

If there is doubt about the diagnosis of premature ovarian insufficiency, refer the woman to a specialist with expertise in menopause or reproductive medicine.

Do not diagnose premature ovarian insufficiency on the basis of a single blood test.

Do not routinely use anti-Müllerian hormone testing to diagnose premature ovarian insufficiency.

NICE Clinical Knowledge Summary: Diagnosis of premature ovarian insufficiency

See below for information on managing premature ovarian insufficiency.

Managing Premature Ovarian Insufficiency

Offer sex steroid replacement with a choice of HRT or a combined hormonal contraceptive to women with premature ovarian insufficiency, unless contraindicated (for example, in women with hormone-sensitive cancer).

Give women with premature ovarian insufficiency and contraindications to hormonal treatments advice, including on bone and cardiovascular health, and symptom management.

Consider referring women with premature ovarian insufficiency to healthcare professionals who have the relevant experience to help them manage all aspects of physical and psychosocial health related to their condition.

Explain to women with premature ovarian insufficiency:

  • the importance of starting hormonal treatment either with HRT or a combined hormonal contraceptive and continuing treatment until at least the age of natural menopause (unless contraindicated)
  • that the baseline population risk of diseases such as breast cancer and cardiovascular disease increases with age and is very low in women aged under 40
  • that HRT may have a beneficial effect on blood pressure when compared with a combined oral contraceptive
  • that both HRT and combined oral contraceptives offer bone protection
  • that HRT is not a contraceptive.

NICE Clinical Knowledge Summary: Osteoporosis – Prevention of fragility fractures: Assessment

Review patients with premature ovarian insufficiency for risk of osteoporosis and fragility fractures. Check FRAX score and consider bisphosphonate treatment if indicated. See formulary chapter 6.6.

Ensure patients are taking vitamin D as self-care in line with [PH56] Vitamin D: supplement use in specific population groups and ensure adequate dietary intake of calcium.

Gender Language and Definitions

The Equality Act 2010 gives legal protection to people who reassign their gender away from the sex they were assigned at birth. Trans people legally are to be treated in accordance with their legal gender identity.   The Equality Act describes gender reassignment as those who ‘propose to undergo, are undergoing or have undergone a process or a part of a process’ to reassign their gender away from the sex assigned at birth.

Not all Trans people will have surgery, not all Trans people will be under the care of the Gender identity clinic (GIC) and not all Trans people will be taking hormones to affirm their gender.

The Gender Recognition Act 2005 provides Trans people with the option to apply for a Gender Recognition Certificate (GRC).  This enables a person to legally change the sex detailed on their birth certificate and other legal documents.   It is not a requirement to change the sex recorded on other records, such as NHS records, bank accounts, etc.  Not all Trans people will choose to apply for a GRC.  A GRC is not required in order to live and be afforded the protection under the Equality Act 2010, as detailed above.  It is neither appropriate nor lawful to ask a person if they have a GRC.

Gender Identity Research and Education Society has information on terminology which you may find useful and more in depth than this short section.

For the purposes of the menopause page, we include women and people assigned female at birth (AFAB) who are perimenopausal or menopausal.

For more resources, please see the Equality and Diversity page.

Osteoporosis

Give advice on bone health and discuss these issues at review appointments.

Explain that the baseline population risk of fragility fracture for women around menopausal age in the UK is low and varies from one woman to another.

Explain to women that their risk of fragility fracture is decreased while taking HRT and that this benefit:

•is maintained during treatment but decreases once treatment stops

•may continue for longer in women who take HRT for longer.

Review patients for risk of osteoporosis and fragility fractures in line with NICE Clinical Knowledge Summary: Osteoporosis – Prevention of fragility fractures: Assessment. Check FRAX score and consider bisphosphonate treatment if indicated. See formulary chapter 6.6.

Ensure patients are taking vitamin D as self-care in line with [PH56] Vitamin D: supplement use in specific population groups and ensure adequate dietary intake of calcium.

Psychological Symptoms and Mental Health in Menopause

Consider HRT for low mood associated with menopause.

Consider CBT for low mood or anxiety associated with menopause.

There is no clear evidence for SSRIs or SNRIs.

See our mental health prescribing page for further mental health resources.

Starting and Stopping HRT

Explain to women and people with a uterus that unscheduled vaginal bleeding is a common side effect of HRT within the first 3 months of treatment but should be reported at the 3-month review appointment, or promptly if it occurs after the first 3 months

Offer women and people who are stopping HRT a choice of gradually reducing or immediately stopping treatment.

Explain that:

-gradually reducing HRT may limit recurrence of symptoms in the short term

-gradually reducing or immediately stopping HRT makes no difference to their symptoms in the longer term.

Summary of HRT Risks

Summary of HRT risks and benefits* during current use and current use plus post-treatment from age of menopause up to age 69 years, per 1000 women with 5 years or 10 years use of HRT

Testosterone

NICE indicates the use of testosterone supplementation for menopausal women with low sexual desire if HRT alone is not effective. Currently this is an off-licence indication. PAMM approved the use of testosterone within guidelines in October 2021, agreeing the Traffic Light Status as GREEN ‘on the advice of a GP with additional training in menopause and hormone replacement therapy or a suitable specialist’.

For detailed information see British Menopause Society – Tools for Clinicians: Testosterone replacement in menopause

BMS Testosterone Patient Information Leaflet

Joint First lineTestim tubes (1% testosterone gel) – 5g tube containing 50mg testosterone. Preferred choice as lid can be replaced between uses.

Apply 1/10th of a tube once daily (5mg daily dose), replace screw lid between uses.

Apply a small pea sized amount once daily to lower abdomen, buttock, or outer thigh. Rotate site of application daily. Use at the same time each day. Replace lid between uses. One tube should last for 10 days.

Joint First lineTestogel sachets 2.5g sachets contain 40.5mg testosterone.

The 5g Sachets containing 50mg testosterone are now no longer being made. Switch patients to the new 2.5g sachets containing 40.5mg and follow directions below – 

Testogel Sachets have changed. The new formulation will be 2.5g sachets containing 40.5mg Testosterone. These sachets should last 8 days and will need to be prescribed with new instructions:

Apply 1/8th of a sachet daily. Apply a small pea sized amount once daily to lower abdomen, buttock or outer thigh. Rotate site of application daily. Use at the same time each day. One 2.5g sachet should last 8 days, seal with a clip between uses.

Second lineTostran pump (2% testosterone gel) – (60g metered dose pump) Apply one metered dose (10mg) three times a week or on alternate days to lower abdomen, buttock, or outer thigh. Rotate site of application daily. Use at the same time each day. 60g pump container delivers 120 metered doses, each cannister should last 240 days. Check stock availability before prescribing.

Do not prescribe the pump version of Testogel or the Testavan Pump as they are unsuitable for HRT in menopause

PRACTICAL TIPS ON PRESCRIBING AND USING TESTOSTERONE

  1. Testosterone gel should be applied to clean, dry skin of the lower abdomen, buttock, or outer thigh, rotating the site of application to avoid hair growth in one area. It should be allowed to dry before dressing. Skin contact with partners and children should be avoided until dry and hands should be washed immediately after application. The area should not be washed for 3 hours after application.
  2. The patient should be on transdermal oestrogen at a sufficient dose to relieve most symptoms before considering if testosterone supplementation is needed.
  3. Blood tests for oestradiol, testosterone, and sex hormone binding globulin (SHBG) levels are now suggested before starting testosterone.
  4. Blood tests are also needed 2 – 3 months after initiation or any dose change and then at least annually once stable. This is to make sure the levels are still within the female physiological range.
  5. It can take at least 3 months to notice any difference in symptoms. If no improvement after 6 months of use, then we would suggest stopping it.
  6. Common side-effects when starting testosterone are greasier hair and skin, spots, increased irritability, frontal hair thinning and weight gain. If these symptoms don’t settle the dose can be reduced before the 3-month review (but patients must never increase the dose without medical advice).
  7. Serious and possibly irreversible side-effects can develop if the dose is too high. These include male pattern hair loss, deepening of the voice, increased body and facial hair, and very rarely an enlarged clitoris.
  8. Please warn patients that the patient information leaflet only relates to male use and give them the patient information leaflet from either the British Menopause Society or Women’s Health Concern.

Patient information

With the Testim gel and Testogel sachets it can take a while for the patient to work out how much to apply each day – suggest starting with a (small) pea-sized amount and then they can adjust up or down depending on how long the first tube/sachet lasts.

The gel should be applied to clean, dry skin and allowed to dry before dressing. Skin contact with partners and children should be avoided until dry and hands should be washed immediately after application. The area should not be washed for 3 hours after application.

Please warn the patients that the patient information leaflet only relates to male use and give them the BMS information leaflet as above.

BLOOD TESTS

Blood tests for oestradiol, testosterone and sex hormone binding globulin are now suggested before starting testosterone.

Any gels normally applied in the morning should be omitted until after the blood test. If using an oestrogen patch, the blood test is best done on day 2.

Please make sure the patient has the blood results at her appointment if not available at the time of the referral.

Calculating the Free Androgen Index is no longer considered helpful.

Unscheduled and Vaginal Bleeding Problems

Explain to women and people with a uterus that unscheduled vaginal bleeding is a common side effect of HRT within the first 3 months of treatment but should be reported at the 3-month review appointment, or promptly if it occurs after the first 3 months (see recommendations on endometrial cancer in the NICE guideline on suspected cancer).

Unscheduled bleeding after 6 months of starting HRT should be reviewed by a GP, with examination where suitable.

Patients may be reluctant to stop HRT to see if bleeding settles due to the benefits of treatment for menopause symptoms which previously affected quality of life.

Topical oestrogen may be useful in patients with vaginal atrophy, see formulary guidance below on vaginal atrophy.

Vaginal bleeding problems– A detailed history:

  • Unscheduled vaginal bleeding is a common adverse effect of HRT within the first 3 months of treatment.
  • Monthly cyclical regimens should produce regular withdrawal bleeding towards the end of the progestogen phase.
  • Continuous combined HRT commonly produces irregular breakthrough bleeding or spotting in the first 4–6 months of treatment. If bleeding persists beyond 6 months, becomes heavier, or occurs after a spell of amenorrhoea, endometrial pathology should be excluded. See the CKS topic on Gynaecological cancers – recognition and referral for more information.
    • Unpredictable or unexpected bleeding may also be due to non-adherence with treatment, drug interactions, or a gastrointestinal disorder (which may affect drug absorption).
  • If serious gynaecological pathology has been excluded, altering the progestogen part of the regimen may improve bleeding problems. Options include:
    • Increasing the duration or dose of the progestogen, or changing the type of progestogen, for example switching to the levonorgestrel-releasing intrauterine system (LNG-IUS, Mirena®) combined with an oral or transdermal oestrogen preparation.

Hormone replacement therapy (HRT) | Prescribing information | Menopause | CKS | NICE

Lichen sclerosis is a chronic inflammatory skin condition which can affect any part of the skin, but it most often affects the genital skin (vulva) and the skin around the anus. It can start in childhood or adulthood, most commonly after menopause. For more information see the NHS Somerset Dermatology formulary page.

For more information, see:

Hormone replacement therapy (HRT) | Prescribing information | Menopause | CKS | NICE

Recommendations | Menopause: diagnosis and management | Guidance | NICE

Gynaecological cancers – recognition and referral | Health topics A to Z | CKS | NICE

Progestogens and endometrial protection- From the British Menopause Society October 2021

Urogenital Atrophy

Offer vaginal oestrogen for urogenital atrophy (including those on systemic HRT) and continue treatment for as long as needed to relieve symptoms.

Consider vaginal oestrogen for urogenital atrophy when systemic HRT is contraindicated (under specialist advice).

Consider increasing dose in inadequate response after seeking specialist advice.

Explain that symptoms may return when treatment ends.

Side effects from vaginal oestrogen are rare.

Urogenital Symptoms:

•Painful intercourse

•Vaginal bleeding – Must be investigated

•Vulvo-vaginal Discomfort

•Infection and discharge

•Itch – the skin around the vulva is more sensitive and more likely to itch in some women. This produces a tendency to scratch which then makes the skin more likely to itch. An itch/scratch cycle follows which can be both difficult to break and quite distressing.

•Urinary problems (frequency/urgency to pass urine)

Urinary symptoms that may occur include one or more of the following: –

Passing water too often (frequency)

Not being able to hold on (urgency)

Pain when passing urine (dysuria)

See formulary chapter 7.4.2 for more information on drugs for urinary frequency.

INVESTIGATE unexplained bleeding

DO NOT offer routine monitoring of endometrial thickness during treatment for urogenital atrophy.

People suffering from vaginal dryness can use genital moisturisers and lubricants, these can be used alone or in addition to vaginal oestrogen. Genital moisturisers and lubricants are suitable for self-care.

Vasomotor symptoms

Offer HRT for vasomotor symptoms after discussing with the patient the short-term (up to 5 years) and longer-term benefits and risks.

Offer a choice of preparations:

  • oestrogen and progestogen to women with a uterus
  • oestrogen alone to women without a uterus.

There is some evidence that isoflavones or black cohosh may relieve vasomotor symptoms (suitable for self-care).

NOTE: Health food supplements may vary, their safety isn’t regulated as medicines are and interactions may be possible.

Healthcare professionals are reminded to be vigilant for suspected adverse reactions associated with the use of herbal and homeopathic medicines and interactions with other medicines and report suspicions to the MHRA’s Yellow Card scheme.

Do not routinely offer selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs) or clonidine as first-line treatment for vasomotor symptoms alone. Clonidine is licensed for and may be considered for hot flushes in people where HRT is not suitable or compatible. Consideration should be taken for side effects and review efficacy after initiation.

Working with Menopause

Menopause and work: why it’s so important

CIPD provides printable resources to help break the stigma around the menopause in workplaces: The menopause at work: printable resources

NHS Employers: Menopause and the workplace