6.4.1 Female sex hormones |
6.4.1.1 Oestrogens and HRT |
Guidance is given below on the type of product required in different situations. The choice of actual preparation (tablet, |
patch, gel) to remain with the prescriber bearing in mind patient preference and the cost differences between the preparations. |
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Note: HRT should only be used for osteoporosis prevention in patients where other therapies are contra-indicated, not tolerated, |
or there is a lack of response. This should ideally be under the direction of a specialist. |
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Women with uterus |
Sequential preparations for patients with an intact uterus & perimenopausal i.e. have not yet had 1 year amenorrhoea. |
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GREEN 1st line Elleste Duet 1mg, 2mg (Estradiol / norethisterone combination) |
GREEN 2nd line Femoston 1/10, 2/10 (Estradiol / dydrogesterone combination) |
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Continuous combined preparations for period free HRT, should only to be used in patients who are amenorrhoeic for 1 year |
or over 54 years if currently on sequential preparation. |
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GREEN 1st line Elleste-Duet Conti (Estradiol/ norethisterone continuous 'no bleed' combination) |
GREEN 2nd line Femoston-Conti (Estradiol/ dydrogesterone continuous 'no bleed' combination) |
GREEN 3rd line Premique (Conj. oestrogens/ medroxyprogesterone continuous 'no bleed' combination) |
BLACK 0.45mg conjugated oestrogens & Bazedoxifene (Duavive®) |
GREEN Micronised Progesterone 100mcg capsules [Utrogestan®] |
GREEN Oestrogel 17β-estradiol Pump Pack 0.06% gel |
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HRT should be trialled for 4 months and reviewed. If progesterone side effects are reported consider switching to Femoston |
products. If oestrogen side effects are reported switch to Prempak-C/ Premique. If side effects of both are severe, consider |
transdermal patches (Evorel Sequi or Evorel Conti). |
HRT patches should be reserved for use in patients with diabetes, liver disease or severe side effects. |
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GREEN Evorel Sequi 50,and 50/170 micrograms in 24 hours (Estradiol/ norethisterone sequential combination) |
GREEN Evorel Conti 50/170 micrograms in 24 hours (Estradiol/ norethisterone continuous 'no bleed' combination) |
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Women without uterus |
Unopposed oestrogen is used for patients with hysterectomy, however in endometriosis, endometrial foci may remain and the use of combination preparations should be considered. |
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GREEN 1st line Elleste Solo 1mg, 2mg (Estradiol) |
GREEN 2nd line Premarin 0.625, 1.25 (Conjugated oestrogens) |
HRT patches should be reserved for use in patients with diabetes, liver disease or severe side effects. |
GREEN Evorel 25, 50, 75, 100 (micrograms in 24 hours) (Estradiol) |
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Where patches are not tolerated but symptoms of menopause require treatment, estradiol gel is an option. |
GREEN Estradiol gel (Sandrena), 500mcg/sachet & 1mg/sachet |
GREEN 17β-estradiol Pump Pack 0.06% gel [Oestrogel® pump pack] |
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Testosterone [transdermal] |
Off-label indication: As Supplementation for Postmenopausal women with low sexual desire if HRT alone is not effective. |
The use of these products is unlicensed for this indication. Tostran 2% gel should be considered before other preparations as |
the dose is measurable. |
> The diagnosis of HSDD must involve a full clinical assessment and other factors contributing to female sexual arousal disorder |
(FSD) must be identified and addressed before testosterone therapy is initiated. |
> Women must be counselled on the absence of long-term safety data for the use of testosterone in women |
> Women must be counselled on the unlicensed nature of the testosterone products available and the implications of this. |
> Tostran should be considered before other preparations as the dose is measurable. We recommend a dose not exceeding |
one full depression of the canister piston (10 mg testosterone) on alternate days. |
> Patients should be monitored for their clinical response to treatment and assessed for signs of androgen excess with a serum |
total testosterone level every 6 months, to screen for overuse. If no benefit is experienced by 6 months, treatment should be |
ceased. |
> In the absence of long-term safety data, women with a history of breast cancer or with a known high risk of breast cancer |
should not be prescribed testosterone. |
> In the absence of long-term safety data, women with cardiovascular disease and/or uncontrolled hypertension should not be |
prescribed testosterone. |
> In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: |
haemoglobin, and haematocrit (to detect polycythaemia), liver function tests, and lipid profile. |
> Improved insulin sensitivity may be observed in patients treated with androgens and may require a decrease in the dose of |
antidiabetic medications. |
Further patient information is available via the RCOG menopause hub: |
https://www.rcog.org.uk/for-the-public/menopause-and-later-life/ |
Link to New Medicine Recommendation |
Please see the Shared Care Guideline here |
AMBER shared care Testosterone transdermal gel |
Tostran® 2% gel [to be considered first], Testim® 50mg/5g gel in tube, Testogel® 50mg/5g gel in sachet |
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Tibolone |
Tibolone increases the risk of breast cancer recurrence in women with a history of breast cancer. Tibolone should not be used |
in women with known or suspected breast cancer, or in those with a history of breast cancer. It should be used for loss of libido only. |
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GREEN Tibolone tablets 2.5mg |
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6.4.1.2 Progestogens and progesterone receptor modulators |
GREEN Medroxyprogesterone tablets 5mg,10mg |
GREEN Norethisterone tablets 5mg |
GREEN Progesterone pessaries 200mg, 400mg |
GREEN Progesterone caps 100mg [Utrogestan®, natural micronised progesterone] |
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Clonidine 25mcg tablets - for vasomotor symptoms associated with menopause |
Where HRT is contraindicated or declined, a trial of clonidine 25mcg tablets may be considered for menopausal VMS. |
Patients should be reviewed after 4 weeks and if no improvement in symptoms is observed or the patient is experiencing |
significant adverse events, treatment should be discontinued. |
GREEN [restricted use] Clonidine 25mcg tablets |
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Moderate to severe symptoms of uterine fibroids |
Relugolix-estradiol-norithisterone acetate - for treating moderate to severe symptoms of uterine fibroids in adults of |
reproductive age is recommended, within its marketing authorisation as an option in NICE TA832 |
AMBER relugolix-estradiol–norethisterone acetate [Ryeqo] |
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MHRA 18th March 2020 - UPDATE |
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ESMYA [Ulipristal acetate]- License suspended to protect public health while a safety review is conducted following a further |
case of liver injury requiring transplant |
[Indications: > Intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age |
> Pre-surgical treatment of moderate to sever symptoms of uterine fibroids in adult women of reproductive age] |
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