Menopause – Guidance on management and prescribing
DIAGNOSIS
The following can be diagnosed without laboratory tests in otherwise
healthy women aged over 45 years with appropriate menopausal
symptoms:
Peri-menopause — if the woman has vasomotor symptoms and
irregular periods.
Menopause in women who have:
not had a period for at least 12 months and are not using
hormonal contraception
OR
symptoms without a uterus
The mean age for the menopause is 52
Follicular Stimulating Hormone (FSH) test to diagnose menopause should only be
done in women:
Aged <40 years where menopause is suspected
Aged 40-45 years with menopausal symptoms, including a change in their
menstrual cycle
Aged >45 years exhibiting atypical symptoms (include anything other than
classic menopausal symptoms)
Level greater than 30 mIU/mL indicates post menopause, should be taken on day 2-
5 of cycle
In women taking hormonal contraception causing amenorrhoea (IUS, POP,
nexplanon) take two levels 6 weeks apart to determine whether menopausal, in
which case contraception can be stopped after 1 year if over 50y.
Some women may have normal levels of FSH during the menopausal transition, so
this should not exclude peri-menopause as a cause of their symptoms
Information and advice
Managing symptoms 1st line Address modifiable lifestyle
factors to reduce menopausal symptoms:
Ensure patients (family or carers) are given
information to include: healthy balanced diet, to maintain an appropriate weight
Explanation of the stages of the menopause consume adequate calcium intake (700mg/day)
Common symptoms and diagnosis undertaking regular weight bearing exercise
Lifestyle changes and interventions to help Advise and support women in smoking cessation and reducing
general health and well being alcohol intake
Benefits and risks of the treatments for Ensure other long term conditions are managed appropriately
menopausal symptoms (see page 4) and any treatment is optimised
Long term health implications of the Avoiding triggers for hot flushes if experiencing them (spicy
menopause foods, alcohol etc.)
Good sleep hygiene
Hormone Replacement Therapy (HRT)
Indications: Contraindications:
Short term relief of vasomotor symptoms e.g. hot flushes, Pregnancy
night sweats Undiagnosed abnormal vaginal bleeding
Prevention of osteoporosis (long term) Active thromboembolic disorder or acute MI
Premature ovarian failure Suspected or active breast or endometrial cancer
Relief of other menopausal symptoms e.g. sleep Active liver disease with abnormal LFTs
disturbance, anxiety/depression, sexual function. Porphyria
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Flow chart for Hormone Replacement Therapy (HRT) prescribing
(refer to table overleaf for formulary choices)
Menopausal symptoms Vaginal
symptoms only
Uterus intact Post hysterectomy
Vaginal estradiol,
lubricants &
moisturisers
Oral oestrogen
Transdermal
Last Menstrual oestrogen
Last Menstrual
Tibolone
Period < 1year Period > 1year or
min 1 year on HRT
Oral sequential combined HRT Oral continuous combined HRT
Patch sequential combined HRT Patch continuous combined HRT
Oral/transdermal single Oral/transdermal single oestrogen
oestrogen with IUS or oral with IUS or progesterone
progesterone Tibolone
Prescribing considerations
Oral therapy is usually first choice – most cost effective and acceptable for the majority of patients.
Where HRT is to be used in women over 60 years of age, lower doses should be started, preferably with a transdermal route of
administration.
Consider patches where:
poor control or side effects on oral HRT variable hypertension (control BP before starting hypertriglyceridaemia
history of, or risk of thrombo-embolism (VTE), consider referring to haematologist for advice
bowel disorder which may affect absorption of oral therapy history of migraine (benefit from steady hormonal levels)
on interacting drugs (hepatic enzyme inducer) e.g. anticonvulsants lactose sensitivity history of gallstones.
When to refer: Premature ovarian insufficiency (POI)
•Persistent side effects despite following logical therapy In POI (menopause under 40 years old) it is important to start
changes treatment with either with HRT or a combined oral
• Inadequate control despite logical changes in HRT contraceptive (COC). Treatment should continue until at least
•Complex medical history the age of natural menopause (unless contraindicated) to
•History of hormone dependent cancer protect against increased risks of dementia, cognitive decline,
Premature ovarian insufficiency (see separate box) cardiovascular disease and osteoporosis seen in these
•Bleeding problems: women.
- during sequential therapy – change in pattern of bleeding Counsel women that:
including increased duration, frequency and/or HRT has a negligible effect on blood pressure and
heaviness, and irregular bleeding beneficial effects on metabolic parameters, when
- during continuous combined therapy or tibolone – if still compared with COC
bleeding after 6 months of therapy or if bleeding occurs Both HRT and COC offer bone protection.
after a spell of amenorrhoea HRT is not contraception
- Selective estrogen receptor modulators (SERMs) – any Consider referring women with POI to a specialist for help and
bleeding whilst on therapy should be treated as a post- support in the physical and psychosocial aspects of their
menopausal bleed diagnosis
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HRT formulary
Type of Sequential combined HRT Continuous combined HRT Unopposed oestrogen HRT Progestogen
HRT (See box below for features)
Criteria Intact uterus Intact uterus - amenorrhoeic >1yr Post hysterectomy As adjunct to topical
for use Perimenopausal – under 1 yr or >54 yrs old oestrogen if not had a
amenorrhoea >3 yrs on sequential HRT hysterectomy
Medroxyprogesterone acetate
st Elleste Duet tablets Elleste Duet Conti Elleste Solo
1 line (Provera) 10mg
1mg or 2mg estradiol & 1mg norethisterone 2mg estradiol & 1mg norethisterone 1mg or 2mg estradiol
Days 14-28 or 5mg daily
ORAL Femoston Conti
Femoston 1/10 or 2/10 tablets
TREATMENT 0.5/2.5 = 0.5mg estradiol & 2.5mg
nd 1mg or 2mg estradiol & 10mg Progesterone 100mg daily or
OPTIONS 2 line dydrogesterone
dydrogesterone 200mg days 14-28
OR
1/5 = 1mg estradiol & 5mg dydrogesterone
rd
3 line Tibolone2.5mg tablets Levonorgestrel (Mirena) Coil
Evorel patch
Evorel Sequi patches Evorel conti patch 25, 50, 75, 100mcg estradiol
st
1 line 50micrograms estradiol & 170micrograms 50micrograms estradiol & 170micrograms Change patch TWICE a week
norethisterone norethisterone
TRANSDERMAL Change patch TWICE a week Change patch TWICE a week
FemSeven Sequi patches FemSeven Conti patches Topical gels: option where skin irritation occurs with patch
nd 50micrograms estradiol & 10micrograms 50micrograms estradiol & 7micrograms Oestrogel
2 line levonorgestrel levonorgestrel 0.06% oestradiol gel
Change patch ONCE a week Change patch ONCE a week 2 measures (2.5g) oestradiol daily
Monitoring Vaginal oestrogen urogenital atrophy
Progestogens (features)
Started on HRT or HRT changed— review at Ovestin cream (0.1% estradiol vaginal cream) OR Synthetics
3months Vagifem (10microgram vaginal tablet) C19 Norethisterone, Norgestrel, Better cycle control, androgenic (may be good
Established on HRT—review annually unless there - start early before irreversible changes have occurred. Can be Levonorgestrel for libido). Unfavourable effect on lipids
taken whilst on systemic HRT. Medroxyprogesterone Can be added to oral or transdermal
are clinical indications for earlier review.
- If symptoms not relieved consider dose increase, after seeking acetate oestrogen, androgenic (may be good for
At each review assess efficacy and side effects to advice from specialist
assess ongoing risk/benefit balance. libido). Unfavourable effect on lipids
- Explain that symptoms may come back when treatment is
stopped, adverse effects are rare. C21 Dydrogesterone Non androgenic. Not available as single
- Moisturisers and lubricants (OTC purchase) can be used alone or preparation
Stopping HRT in addition to vaginal oestrogen for vaginal dryness. Levonorgestrel (IUS) Replace after 5 years as per FSRH guidance.
Consider weaning dose down after 5 years of DO NOT offer routine monitoring of endometrial thickness during There is minimal systemic absorption.
HRT (5 years after reaching average menopausal treatment. Report any unscheduled bleeding promptly. Naturally occurring
age in POI). Withdraw HRT slowly to reduce risk Micronised progesterone (Utrogestan) Fewer progestogenic S/e’s, Non androgenic or
of recurrent symptoms. glucocorticoid activity. No lipid effects. Less
If preparation exists at lower dose reduce dose for 4 weeks then stop
If symptoms do recur then recommence effective cycle control
If already on lowest dose or no lower strength exists then stop
treatment.
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Benefits and risks of HRT
Benefits of HRT Cardiovascular disease
HRT does not increase coronary heart disease (CHD) risk when started in women aged under 60 yrs
Reduction in vasomotor symptoms Relief vaginal dryness old, and does not affect the risk of dying from cardiovascular disease.
Improved sleep, joint pain & QOL Improved sexual function
Cardiovascular co-morbidities are not a contra-indication to HRT as long as they are optimally
Potential improvement in psychological Improved bone mineral density, reduced
managed.
symptoms e.g. depression & anxiety fracture risk
Monotherapy oestrogen HRT is associated with no, or reduced, risk of CHD.
Combined HRT is associated with minimal or no increase in the risk of CHD.
Oral oestrogen is associated with small increase in risk of stroke. As the baseline risk of stroke in
women under 60 yrs is very low the increased risk is insignificant
Venous thromboembolism (VTE)
Managing side effects Risk is increased (RR =2) by oral HRT compared to baseline population risk. (low risk)
Encourage women to persist with treatment for 3 months (as adverse effects may resolve) Risk associated with transdermal HRT given at standard therapeutic doses (under 50mcg/24hr) is no
Oestrogen-related Progestogen related greater than baseline population risk.
Fluid retention, bloating, breast tenderness or Fluid retention, breast tenderness, headaches or Consider transdermal rather than oral HRT in women with an increased risk of VTE, e.g. BMI over 30.
enlargement, nausea, headaches, leg cramps, migraine, mood swings, depression, acne, lower Consider referring women with high risk of VTE to haematologist for assessment before considering
and dyspepsia. abdominal pain, and back pain. HRT.
They may occur continuously or randomly They tend to occur in a cyclical pattern during the
Type 2 diabetes
throughout the cycle. progestogen phase of cyclical hormone
There is no increased risk of developing type 2 diabetes with any type of HRT.
replacement therapy (HRT).
HRT is not associated with an adverse effect on blood glucose control in diabetics.
Management strategies
◦Change route of delivery ◦Changing the progestogen type(see Progestogens Osteoporosis
◦Dose reduction features table) Give women advice on bone health and discuss any risk factors for osteoporosis.
◦Leg cramps may improve with lifestyle changes ◦Change route of delivery Risk of fragility fractures is decreased whilst taking HRT but increases once treatment is stopped,
e.g. exercise, stretching calf muscles. ◦Dose reduction although may persist for a while in women who take HRT for longer.
◦Nausea adjust the timing of the oestrogen dose ◦Reducing the regimen of progestogen
or taking with food. administration. Progestogens can be taken for 10– Loss of muscle mass and strength
◦Breast tenderness may be alleviated by a low- 14 days of each monthly sequential regimen, so There is limited evidence suggesting that HRT may improve muscle mass and strength, which would
fat, high-carbohydrate diet. swapping from a 14-day to a 10-day product may otherwise decrease after the menopause. Muscle mass and strength is also maintained through daily
◦Migraine – switch to transdermal provide benefit. activities and weight bearing exercise.
◦Changing to a product with a lower dose of
Breast cancer
progestogen (doses are preparation dependent).
Oestrogen only HRT is associated with little or no increase in the risk of breast cancer
◦Reducing the frequency of progestogen dosing.
Combined HRT can be associated with an increase in the risk of breast cancer , however this increase is
This can be achieved by switching to a long-cycle
small and is related to HRT duration and reduces after stopping.
regimen of administering progestogen for 14 days
The baseline risk of getting breast cancer is 15 cases per 1000 women over 5 years.
every 3 months (but only in women without
The Women Health Institute study suggests that if 1000 women used HRT for 5 years there would be 4
natural regular periods).
extra cases of breast cancer with combined HRT and 4 fewer cases with oestrogen only HRT.
• Changing to continuous combined therapy or
tibolone often reduces progestogenic adverse
Ovarian cancer
effects with established use. However, this option
A 2015 meta-analysis of 52 epidemiological studies has shown an increased risk of ovarian cancer with all
is only suitable for postmenopausal women.
types of HRT. Whilst this study provides evidence of an association between HRT use and some tumour
subtypes, there is insufficient evidence to claim HRT causes ovarian cancer. When counselling patients it
is important to discuss these findings in terms of absolute risk.
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After 5 years of HRT there is only 0.1% increase in ovarian cancer and less than 0.6% additional deaths.
Title Menopause – Guidance on management and prescribing
Document reference MenopauseGUI201606V1.0FINAL
References NICE guidelines [NG23] Menopause: diagnosis and management, November 2015
[Link]
NICE Clinical Knowledge Summaries Menopause last revised October 2015
[Link]
Menopause matters guidelines. Hormone replacement therapy. Updated January 2011.
[Link]
Author Dr Imogen Shaw, GPwSI
Natalie Leong, Senior Pharmacist MECCG
Approved by Area Prescribing Committee
Date approved July 2016
Next review date July 2018
Previous version Key Changes
N/A New guidance
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