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6.4.1 Female sex hormones

6.4.1 Female sex hormones


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.
 
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.
 
Women with uterus
Sequential preparations for patients with an  intact uterus &   perimenopausal i.e. have not yet had 1 year amenorrhoea.
 
GREEN       1st line Elleste Duet 1mg, 2mg    (Estradiol / norethisterone combination) 
GREEN       2nd line Femoston 1/10, 2/10     (Estradiol / dydrogesterone combination)
 
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.
 
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
 
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.
 
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)     
 
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. 
 
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)     
 
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]

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   
 
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.
 
GREEN      Tibolone tablets 2.5mg 
 
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]
 
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
 
MHRA 18th March 2020 - UPDATE
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]
 
 
BLACK         Ulipristal acetate tablets 5mg (Esmya®) - SEE MHRA DRUG SAFETY UPDATE
 
 
 
 
 
 
 

All material in this section is aimed at health care professionals, but is information currently held in the public domain, members of the  
public seeking advice on medicine-related matters are advised to speak with their GP, pharmacist, nurse or contact NHS111 Service. 
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