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6.4 Sex hormones 

Refer to HRT algorithm for further guidance on product selection. 

Hormone Replacement Therapy (HRT) may be used in women for the short-term treatment of menopausal symptoms.  The benefits are considered to outweigh the risks for the majority of women, particularly in those aged less than 60 years.  The lowest effective dose should be used for the shortest duration; each decision to start HRT should be made on an individual basis with a fully informed woman and after assessment of overall risk.  Treatment should be reviewed at least annually to discuss any new knowledge and any changes in a woman’s risk factors. For the background to this advice and more detailed advice and information on the potential risks of long-term HRT go to the  MHRA website  For further information on tibolone and breast cancer recurrence Click here (page 2).

For further information on prescribing HRT including benefits and risks of treatment see the Tayside Menopause Guidelines

HRT: The CSM advises that HRT should not be considered first-line therapy for the long-term prevention of osteoporosis in women who are over 50 years of age and at an increased risk of fractures. HRT remains an option for those who are intolerant of other osteoporosis prevention therapies, for whom these are contra-indicated, or for whom there is evidence of a lack of response to other therapies. In such cases the individual risk:benefit balance should be carefully assessed. HRT may be used in younger women who have experienced a premature menopause (due to ovarian failure, surgery or other causes) for treating their menopausal symptoms and for preventing osteoporosis until the age of 50 years. After this age, therapy for preventing osteoporosis should be reviewed and HRT considered a second-line choice.

Oestrogens and hormone replacement therapy 

·   Oestrogen may be given orally, transcutaneously as a patch or gel, or as in implant. 

·   There can be considerable variation in response to different HRT preparations.  Each woman should be encouraged to persevere with a preparation for 2-3months (as side-effects may settle in this time) before considering changing.  However, often 2 or 3 preparations need to be tried before a suitable one is found. 

·   HRT is not a method of contraception. 

For women without a uterus

Elleste-Solo® tablets estradiol 1mg, 2mg
Dose:
Menopausal symptoms, (including second-line osteoporosis prophylaxis in the case of Elleste-Solo® 2mg only), 1-2mg daily.

Evorel® transdermal matrix patches estradiol 25, 50, 75, 100micrograms/24hrs
Dose:
Menopausal symptoms (including second-line osteoporosis prophylaxis in the case of Evorel® 50, 75, 100 only), 1 patch to be applied twice weekly on a continuous basis, therapy should be initiated with “50” patch for first month, subsequently adjusted to lowest effective dose.

FemSeven® transdermal matrix patches estradiol 50, 75, 100micrograms/24 hrs
Dose:
Menopausal symptoms and second-line osteoporosis prophylaxis, 1 patch to be applied once a week continuously, therapy should be initiated with “50” patch for the first few months, subsequently adjusted according to response.

Estraderm MX® transdermal matrix patches estradiol 25, 50, 75,100 micrograms/24hrs
Dose:
Menopausal symptoms, (and second-line osteoporosis prophylaxis in the case of Estraderm MX® 50 and 75 only), as Evorel®

Women without a uterus, post hysterectomy require only oestrogens.   FemSeven® patch may be preferred by some women as it requires to be changed only once weekly. 

For women with a uterus 

Women with a uterus require progestogen in addition to oestrogen to protect the endometrium. Progestogens can be given cyclically or continuously.

·      Women under 54 years or within 12 months of last menstrual period should receive cyclical combined therapy whereas,

·      Women over 54 years or one year post menopause (i.e. 12 months since last menstrual period) should receive a continuous combined oestrogen and progestogen preparation.

Prolonged use of cyclical HRT can increase the risk of endometrial cancer. Women should not be kept on cyclical therapy for longer than 2 years, unless it is necessary to change back for a short time if bleeding problems occur.

·     If under 54 years, cyclical therapy should be given for 2 years then changed to a continuous combined regimen. 

Progestogens can be divided into two groups:

·     C19 (testosterone derivatives) e.g. norethisterone, levonorgestrel, norgestrel and

·     C21 (progesterone derivatives) e.g. medroxyprogesterone acetate (MPA).
 If side-effects experienced with C19 progestogen, change to C21 and vice-versa.
 

Oestrogen with cyclical progestogen

Elleste-Duet® tablets estradiol 1mg/norethisterone 1mg, estradiol 2mg/norethisterone 1mg
Dose:
Elleste-Duet® 1mg, menopausal symptoms, 1 white tablet daily for 16 days, starting on day 1 of menstruation (or any time if cycles have ceased or are infrequent) then 1 green tablet for 12 days; subsequent courses are repeated without interval. Elleste-Duet® 2mg, menopausal symptoms and second-line osteoporosis prophylaxis, see under 1mg dose but taking 1 orange tablet for 16 days then 1 grey tablet for 12 days.

Femoston® tablets estradiol 1mg/dydrogesterone 10mg, estradiol 2mg/dydrogesterone 10mg.
 Dose: Femoston® 1/10, menopausal symptoms and second-line osteoporosis prophylaxis, 1 white tablet daily for 14 days, starting within 5 days of onset of menstruation (or any time if cycles have ceased or are infrequent), then 1 grey tablet for 14 days; subsequent courses are repeated without interval. Femoston® 2/10, see under Femoston® 1/10, but taking 1 red tablet for 14 days, then 1 yellow tablet for 14 days.

Evorel Sequi® transdermal matrix patches estradiol 50micrograms/24 hrs, norethisterone 170micrograms/24 hrs
Dose:
Menopausal symptoms and second-line osteoporosis prophylaxis, 1 Evorel® 50 patch to be applied twice weekly for 2 weeks followed by 1 Evorel Conti® patch twice weekly for 2 weeks; subsequent courses are repeated without interval.
 

Oestrogen with continuous progestogen  

Kliovance® tablets estradiol 1mg/norethisterone acetate 500micrograms
Dose:
Menopausal symptoms and second-line osteoporosis prophylaxis, 1 tablet daily continuously.

Elleste-Duet Conti® tablets estradiol 2mg/norethisterone acetate 1mg.
Dose:
Menopausal symptoms and second-line osteoporosis prophylaxis, 1 tablet daily on a continuous basis.

Femoston Conti® tablets estradiol 1mg/dydrogesterone 5mg
Dose:
Menopausal symptoms and second-line osteoporosis prophylaxis, 1 tablet daily continuously.

Evorel Conti® transdermal matrix patches estradiol 50micrograms/24 hrs, norethisterone acetate 170micrograms/24 hrs.
Dose:
Menopausal symptoms and second-line osteoporosis prophylaxis, 1 patch to be applied twice weekly continuously. 

Kliovance® and Femoston Conti® are low dose continuous combined preparations, whereas, Elleste-Duet® preparations are higher dose preparations required if symptoms not fully controlled with lower strength.  FemSeven Sequi® and FemSeven Conti® are estradiol HRT patches with sequential and continuous levonorgestrel that require once weekly changes which may be preferred by some women.  They are not licensed for osteoporosis. Refer to HRT algorithm for further guidance on product selection. 

Other 

Raloxifene tablets 60mg
Dose:
treatment and prevention of osteoporosis in postmenopausal women, 60mg once daily.

Raloxifene does not reduce menopausal vasomotor symptoms.

Tibolone tablets 2.5mg
Dose:
Menopausal symptoms and second-line osteoporosis prophylaxis, 2.5mg daily.
       

Tibolone is an alternative to HRT for the treatment of menopausal symptoms and is also indicated as second-line osteoporosis prophylaxis.  However in women over approximately 60 years the risks associated with tibolone start to outweigh the benefits because of the increased risk of stroke.  This increased risk of stroke with tibolone should be weighed against the increased risk of breast cancer with combined HRT for women with a uterus.  See MHRA Drug Safety Update for further information. 

Progestogens

Norethisterone tablets 5mg
Dose:
Endometriosis, 10-15mg daily for 4-6 months or longer, starting on 5th day of cycle (increased if spotting occurs to 20-25mg daily, reduced once bleeding has stopped). Menorrhagia, 5mg 3 times daily for 10 days to arrest bleeding; to prevent bleeding, 5mg twice daily from 19th to 26th day. Dysmenorrhoea, 5mg 3 times daily from 5th to 24th day for 3 to 4 cycles. Postponement of menstruation, 5mg 3 times daily starting 3 days before anticipated onset (menstruation occurs 2 to 3 days after stopping).

The progestogen norethisterone is used in menstrual disorders and endometriosis.  In menorrhagia, oral progestogens are relatively ineffective compared with other therapies, see BNF for further information.  The progestogen-only intra-uterine system, Mirena®, releases levonorgestrel directly into the uterine cavity. It is licensed for use as a contraceptive and for the treatment of primary (idiopathic) menorrhagia. This may therefore be a contraceptive method of choice for women who have excessively heavy menses. Return of fertility after removal is rapid and appears to be complete. Mirena® is also licensed for four years as the progestogen component of an HRT regimen.

Male sex hormone antagonists
Drugs for benign prostatic enlargement
 

See section 7.4 for information on finasteride and dutasteride.

6.1   Drugs used in diabetes
6.2   Thyroid and antithyroid drugs
6.3   Corticosteroids
6.5   Pituitary hormones
6.6   Drugs affecting bone metabolism
6.7 Other endocrine drugs
Guidance on HRT Product Selection

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© 2010 NHS Tayside