relatively ineffective compared with tranexamic acid p. 110
or, particularly where dysmenorrhoea is also a factor,
requiring contraception. Oral progestogens have also been
used for severe dysmenorrhoea, but where contraception is
also required in younger women the best choice is a
Progestogens have also been advocated for the alleviation
of premenstrual symptoms, but no convincing physiological
basis for such treatment has been shown.
Progestogens have been used for the prevention of
miscarriage in women with a history of recurrent miscarriage
but there is no evidence of benefit and they are not
recommended for this purpose. In pregnant women with
antiphospholipid antibody syndrome who have suffered
recurrent miscarriage, administration of low-dose aspirin
p. 121 and a prophylactic dose of a low molecular weight
heparin may decrease the risk of fetal loss (use under
In women with a uterus a progestogen needs to be added to
long-term oestrogen therapy for hormone replacement, to
prevent cystic hyperplasia of the endometrium and possible
transformation to cancer; it can be added on a cyclical or a
continuous basis. Combined packs incorporating suitable
progestogen tablets are available.
Desogestrel, gestodene, levonorgestrel, norethisterone, and
norgestimate are used in combined oral contraceptives and
in progestogen-only contraceptives.
Progestogens also have a role in neoplastic disease.
Progesterone receptor modulators
Ulipristal acetate p. 804 is a progesterone receptor
modulator with a partial progesterone antagonist effect.
Ulipristal acetate is used in the pre-operative treatment of
moderate to severe symptoms of uterine fibroids (see
important safety information in ulipristal acetate). Ulipristal
acetate is also used as an hormonal emergency
Endometriosis is the growth of endometrial-like tissue
outside the uterus. Endometriosis is a condition affecting
women mainly of reproductive age and, although its exact
cause is unknown, it is an oestrogen-dependent condition
and is associated with menstruation. Endometriosis is
typically associated with symptoms such as pelvic pain,
painful periods and subfertility. Women with endometriosis
report pain, which can be frequent, chronic and severe, as
well as tiredness, more sick days, and a significant physical,
sexual, psychological and social impact. Endometriosis is an
important cause of subfertility and this can also have a
significant effect on quality of life.
Women may also have endometriosis without symptoms,
so it is difficult to know how common the disease is in the
population. It is also unclear whether endometriosis is
Breast cancer1 50–59 10 20 2 6 6 24
Endometrial cancer2,3 50–59 2 4 4 32 NS NS
Ovarian cancer 50–59 2 4 <1 1 <1 1
thromboembolism4,5 50–59 5 — 2 — 7 —
Coronary heart disease7,8 70–79 29-44 — NS — 15 —
1 Tibolone increases the risk of breast cancer but to a lesser extent than with combined HRT.
stroke with tibolone increases with age.
752 Sex hormone responsive conditions BNF 78
always progressive or can remain stable or improve with
The aim of treatment is to reduce the severity of symptoms,
improve the quality of life, and to improve fertility if this is
Management options for endometriosis include drug
treatment and surgery. Most drug treatments for
endometriosis work by suppressing ovarian function and are
contraceptive. Surgical treatment aims to remove or destroy
endometriotic lesions. The choice of treatment depends on
the woman’s preferences and priorities in terms of pain
g A short trial (such as 3 months) of paracetamol or an
NSAID alone or in combination should be considered for
first-line management of endometriosis-related pain. If pain
relief is inadequate, consider other forms of pain
management and referral for further assessment.
Hormonal treatment (with a combined oral contraceptive
or a progestogen) should be offered to women with
suspected, confirmed or recurrent endometriosis. The
patient should be informed that hormonal treatment for
endometriosis can reduce pain and has no permanent
negative effect on subsequent fertility. If initial hormonal
treatment for endometriosis is not effective, not tolerated or
is contra-indicated, the woman should be referred to a
gynaecologist or specialist endometriosis service for possible
further treatment, which could include other hormonal
treatments or surgery. hFor use of drugs to treat
neuropathic pain, see Neuropathic pain.
g Women with suspected or confirmed endometriosis
should be asked about their symptoms, preferences and
priorities with respect to pain and fertility, to guide surgical
decision-making. For deep endometriosis involving the
bowel, bladder or ureter, gonadotropin-releasing hormones
given for 3 months before surgery should be considered.
Excision rather than ablation should be considered to treat
endometriomas, taking into account the woman’s desire for
fertility and her ovarian reserve. After laparoscopic excision
or ablation of endometriosis, consider hormonal treatment
(with, for example, a combined hormonal contraceptive), to
prolong the benefits of surgery and manage symptoms.
A hysterectomy may be indicated if, for example, the
woman has adenomyosis or heavy menstrual bleeding that
has not responded to other treatments. h
Surgical management if fertility is a priority
g If fertility is a priority, the management of
endometriosis-related subfertility should have
multidisciplinary involvement with input from a fertility
specialist. Women with endometriosis who are trying to
conceive should not be offered hormonal treatment, because
it does not improve spontaneous pregnancy rates. h
Endometriosis: diagnosis and management. National
Institute for Health and Care Excellence. NICE guidance 73.
Heavy menstrual bleeding 04-Jan-2019
Heavy menstrual bleeding, also known as menorrhagia, is
excessive menstrual blood loss of 80 mL or more, or for a
duration of more than 7 days, which results in the need to
change menstrual products every 1–2 hours. Heavy
menstrual bleeding occurs regularly, every 24–35 days.
g The choice of treatment should be guided by the
presence or absence of fibroids (including size, number and
location), polyps, endometrial pathology or adenomyosis,
other symptoms (such as pressure or pain), co-morbidities,
In females with heavy menstrual bleeding and unidentified
pathology, fibroids less than 3 cm in diameter causing no
distortion of the uterine cavity, or suspected or diagnosed
adenomyosis, a levonorgestrel-releasing intra-uterine
system p. 806 is the first-line treatment option. Patients
should be advised that irregular menstrual bleeding can
occur particularly during the first months of use and that the
full benefit of treatment may take at least 6 months.
If a levonorgestrel-releasing intra-uterine system p. 806 is
unsuitable, either tranexamic acid p. 110, an NSAID, a
combined hormonal contraceptive, or a cyclical oral
progestogen should be considered. Progestogen-only
contraceptives may suppress menstruation and be beneficial
to females with heavy menstrual bleeding. A non-hormonal
treatment is recommended in patients actively trying to
If drug treatment is unsuccessful or declined by the
patient, or if symptoms are severe, referral to a specialist for
alternative drug treatment or surgery should be considered.
In females with fibroids of 3 cm or more in diameter,
referral to a specialist should be considered. Treatment
options include tranexamic acid, an NSAID, ulipristal acetate
p. 804, a levonorgestrel-releasing intra-uterine system
p. 806, a combined hormonal contraceptive, a cyclical oral
progestogen, uterine artery embolisation, or surgery.
Treatment choice depends on the size, number and location
of the fibroids, and severity of symptoms. If drug treatment
is required while investigations and definitive treatment is
being organised, either tranexamic acid, or an NSAID, or
Intermittent ulipristal acetate can be offered to females
who are not eligible for surgery and have a haemoglobin
concentration of 10.2 g/100 mL (102 g/litre) or less. If the
haemoglobin concentration is more than 10.2 g/100 mL
(102 g/litre), ulipristal acetate may be considered. The use of
ulipristal acetate is associated with a risk of rare but serious
liver injury; liver function should be monitored during
treatment, see Important safety information, and Monitoring
requirements in ulipristal acetate. h
The effectiveness of drug treatment (excluding ulipristal
acetate) for heavy menstrual bleeding may be limited in
females with fibroids that are substantially greater than 3 cm
in diameter.g Treatment with a gonadotrophin-releasing
hormone analogue or ulipristal acetate before hysterectomy
and myomectomy should be considered if uterine fibroids
are causing an enlarged or distorted uterus. h
Heavy menstrual bleeding: assessment and management.
National Institute for Health and Care Excellence. NICE
Other drugs used for Female sex hormone responsive
conditions Clonidine hydrochloride, p. 145 . Ulipristal acetate,
BNF 78 Female sex hormone responsive conditions 753
CALCIUM REGULATING DRUGS › BONE
Raloxifene hydrochloride 20-Feb-2019
Treatment and prevention of postmenopausal
Breast cancer [chemoprevention in postmenopausal
women at moderate to high risk] (initiated under
▶ Adult: 60 mg once daily for 5 years
l UNLICENSED USE Not licensed for chemoprevention of
breast cancer in the UK. Licensed for this indication in
l CAUTIONS Avoid in Acute porphyrias p. 1058 . breast
cancer (manufacturer advises avoid during treatment for
breast cancer). history of oestrogen-induced
hypertriglyceridaemia (monitor serum triglycerides).risk
factors for stroke .risk factors for venous
thromboembolism (discontinue if prolonged
l INTERACTIONS → Appendix 1: raloxifene
▶ Common or very common Influenza . leg cramps . peripheral oedema . vasodilation
▶ Uncommon Embolism and thrombosis
▶ Rare or very rare Breast abnormalities . gastrointestinal
discomfort. gastrointestinal disorder. headaches . nausea . rash .thrombocytopenia . vomiting
l HEPATIC IMPAIRMENT Manufacturer advises avoid (risk of
l RENAL IMPAIRMENT Caution in mild to moderate
impairment. Avoid in severe impairment.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Raloxifene for the primary prevention of osteoporotic fragility
fractures in postmenopausal women (updated February 2018)
Raloxifene is not recommended as a treatment option for
the primary prevention of osteoporotic fragility fractures
Women who are currently receiving treatment, but for
whom treatment would not have been recommended,
should have the option to continue treatment until they
and their NHS clinician consider it appropriate to stop.
www.nice.org.uk/guidance/ta160
▶ Raloxifene and teriparatide for the secondary prevention of
osteoporotic fragility fractures in postmenopausal women
(updated February 2018) NICE TA161
Raloxifene is recommended as an alternative treatment
option for the secondary prevention of osteoporotic
fragility fractures in postmenopausal women:
. who are unable to comply with the special instructions
for the administration of alendronate and risedronate, or
have a contra-indication to or are intolerant of
alendronate and risedronate, and
. have a combination of T-score, age and number of
independent clinical risk factors for fracture, as
indicated in the full NICE guidance.
Women who are currently receiving treatment, but for
whom treatment would not have been recommended,
should have the option to continue treatment until they
and their NHS clinician consider it appropriate to stop.
www.nice.org.uk/guidance/ta161
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Raloxifene hydrochloride (Non-proprietary)
Raloxifene hydrochloride 60 mg Raloxifene 60mg tablets |
28 tablet P £17.06 DT = £3.49 | 84 tablet P £10.47–£43.50
Raloxifene hydrochloride 60 mg Evirex 60mg tablets | 28 tablet P £5.10 DT = £3.49
▶ Evista (Daiichi Sankyo UK Ltd)
Raloxifene hydrochloride 60 mg Evista 60mg tablets | 28 tablet P £17.06 DT = £3.49
Raloxifene hydrochloride 60 mg Razylan 60mg tablets | 28 tablet P £17.06 DT = £3.49
Conjugated oestrogens (equine)
▶ Adult: 0.3–1.25 mg daily continuously; with cyclical
progestogen for 12–14 days of each cycle in women
Postmenopausal osteoporosis prophylaxis
▶ Adult: 0.625–1.25 mg daily continuously; with cyclical
progestogen for 12–14 days of each cycle in women
l CONTRA-INDICATIONS Active arterial thromboembolic
disease (e.g. angina or myocardial infarction). active
thrombophlebitis .Dubin-Johnson syndromes (or monitor
closely). history of breast cancer. history of recurrent
venous thromboembolism (unless already on
anticoagulant treatment). liver disease (where liver
(e.g. angina or myocardial infarction). Rotor syndromes
(or monitor closely).thrombophilic disorder. undiagnosed
vaginal bleeding . untreated endometrial hyperplasia . venous thromboembolism
l CAUTIONS Acute porphyrias p. 1058 . diabetes (increased
risk of heart disease). factors predisposing to
thromboembolism . history of breast nodules (closely
monitor breast status—risk of breast cancer). history of
endometrial hyperplasia . history of fibrocystic disease
thrombotic events).risk factors for oestrogen-dependent
tumours (e.g. breast cancer in first-degree relative).risk of
▶ Risk of breast cancer It is estimated that using all types of
HRT, including tibolone, increases the risk of breast cancer
within 1–2 years of initiating treatment. The increased risk
is related to the duration of HRT use (but not to the age at
which HRT is started) and this excess risk disappears
Radiological detection of breast cancer can be made
more difficult as mammographic density can increase with
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