Drug reference
Anti-oestrogen which induces Endocrine system gonadotrophin release by occupying oestrogen receptors in the hypothalamus, thereby interfering with feedback mechanisms; chorionic gonadotrophin is sometimes used as an adjunct.
PDF page 831
Female infertility due to ovulatory dysfunction ▶BY MOUTH ▶Adult (female): 50 mg once daily for 5 days, to be started at any time if no recent uterine bleeding or on or around the fifth day of cycle if progestogen-induced bleeding is planned or if spontaneous uterine bleeding occurs, then 100 mg once daily if required for 5 days, this second course to be given at least 30 days after the first course, only in the absence of ovulation; most patients who are going to respond will do so to first course, 3 courses should constitute adequate therapeutic trial; long-term cyclical therapy not recommended (beyond a total of 6 cycles).
PDF page 831
Abnormal uterine bleeding of undetermined cause. hormone-dependent tumours. ovarian cysts Breast cancer in males. history of liver tumours. hypercalcaemia. prostate cancer
PDF pages 831, 832
Ectopic pregnancy. incidence of multiple births increased (consider ultrasound monitoring). ovarian hyperstimulation syndrome. polycystic ovary syndrome (cysts may enlarge during treatment, also risk of exaggerated response to usual doses). uterine fibroids Cardiac impairment. diabetes mellitus. elderly . epilepsy. hypertension. ischaemic heart disease. migraine. pre-pubertal boys (fusion of epiphyses is hastened and may result in short stature)—statural growth and sexual development should be monitored. risk factors for venous thromboembolism. skeletal metastases—risk of hypercalcaemia or hypercalciuria (if this occurs, treat appropriately and restart treatment once normal serum calcium concentration restored). sleep apnoea. stop treatment or reduce dose if severe polycythaemia occurs. thrombophilia—increased risk of thrombosis. tumours— risk of hypercalcaemia or hypercalciuria (if this occurs, treat appropriately and restart treatment once normal serum calcium concentration restored) CAUTIONS, FURTHER INFORMATION ▶Elderly Prescription potentially inappropriate (STOPP criteria) in the absence of primary or secondary hypogonadism (risk of androgen toxicity; no proven benefit outside of the hypogonadism indication). See also Prescribing in the elderly p. 33.
PDF pages 831, 832
Manufacturer advises clomifene should not normally be used for longer than 6 cycles (possible increased risk of ovarian cancer).
PDF page 831
Abdominal distension. alopecia. angioedema. anxiety. breast tenderness. cataract. cerebral thrombosis. depression. disorientation. dizziness . fatigue. headache. hot flush. hypertriglyceridaemia. insomnia. jaundice cholestatic. menstrual cycle irregularities. mood altered. nausea. neoplasms. nervous system disorders. optic neuritis. ovarian and fallopian tube disorders. palpitations. pancreatitis. paraesthesia. psychosis. seizure. skin reactions. speech disorder. stroke . syncope. tachycardia. uterine disorders. vertigo. vision disorders. visual impairment (discontinue and initiate ophthalmological examination). vomiting ▶Common or very common Hot flush. hypertension. polycythaemia. prostate abnormalities. skin reactions. weight increased ▶Uncommon Alopecia. asthenia. behaviour abnormal. depression. dizziness. dyspnoea. dysuria. gynaecomastia . headache. hyperhidrosis. insomnia. nausea. sexual dysfunction ▶Rare or very rare Pulmonary oil microembolism ▶Frequency not known Anxiety. epiphyses premature fusion . fluid retention. jaundice. oedema. oligozoospermia. paraesthesia. precocious puberty. prostate cancer. seborrhoea. sleep apnoea. urinary tract obstruction SIDE-EFFECTS, FURTHER INFORMATION Stop treatment or reduce dose if severe polycythaemia occurs.
PDF pages 831, 832
Exclude pregnancy before treatment.
PDF page 831
Possible effects on fetal development. Avoid—causes masculinisation of female fetus.
PDF pages 831, 832
May inhibit lactation. Avoid.
PDF pages 831, 832
Manufacturer advises avoid in liver disease or history of liver dysfunction. In general, manufacturers advise caution (increased risk of fluid retention and heart failure).
PDF pages 831, 832
Caution—potential for fluid retention.
PDF page 832
▶Monitor haematocrit and haemoglobulin before treatment, every three months for the first year, and yearly thereafter. ▶Monitor prostate and PSA in men over 45 years.
PDF page 832
There can be variation in the licensing of different medicines containing the same drug. Tablet ▶Clomifene citrate (Non-proprietary) Clomifene citrate 50 mg Clomifene 50mg tablets | 30 tablet P £13.33 DT = £10.15 ▶Clomid (Sanofi) Clomifene citrate 50 mg Clomid 50mg tablets | 30 tablet P £10.15 DT = £10.15 Endocrine system 8.2 Male sex hormone responsive conditions Androgens, anti-androgens and anabolic steroids Androgens Androgens cause masculinisation; they may be used as replacement therapy in castrated adults and in those who are hypogonadal due to either pituitary or testicular disease. In the normal male they inhibit pituitary gonadotrophin secretion and depress spermatogenesis. Androgens also have an anabolic action which led to the development of anabolic steroids. Androgens are useless as a treatment of impotence and impaired spermatogenesis unless there is associated hypogonadism; they should not be given until the hypogonadism has been properly investigated. Treatment should be under expert supervision. When given to patients with hypopituitarism they can lead to normal sexual development and potency but not to fertility. If fertility is desired, the usual treatment is with gonadotrophins or pulsatile gonadotrophin-releasing hormone which will stimulate spermatogenesis as well as androgen production. Intramuscular depot preparations of testosterone esters are preferred for replacement therapy. Testosterone enantate, propionate or undecanoate, or alternatively Sustanon ®, which consists of a mixture of testosterone esters and has a longer duration of action, may be used. Anti-androgens Cyproterone acetate Cyproterone acetate p. 812 is an anti-androgen used in the treatment of severe hypersexuality and sexual deviation in the male. It inhibits spermatogenesis and produces reversible infertility (but is not a male contraceptive); abnormal sperm forms are produced. Fully informed consent is recommended and an initial spermatogram. As hepatic tumours have been produced in animal studies, careful consideration should be given to the risk/benefit ratio before treatment. Cyproterone acetate is also licensed for use alone in patients with metastatic prostate cancer refractory to gonadorelin analogue therapy and has been used as an adjunct in prostatic cancer and in the treatment of acne and hirsutism in women. Dutasteride and finasteride Dutasteride p. 830 and finasteride p. 831 are alternatives to alpha-blockers particularly in men with a significantly enlarged prostate. Finasteride is also licensed for use with doxazosin p. 826 in the management of benign prostatic hyperplasia. A low strength of finasteride is licensed for treating male- pattern baldness in men. Anabolic steroids Anabolic steroids have some androgenic activity but they cause less virilisation than androgens in women. They are used in the treatment of some aplastic anaemias. Anabolic steroids have been given for osteoporosis in women but they are no longer advocated for this purpose. The protein-building properties of anabolic steroids have not proved beneficial in the clinical setting. Their use as body builders or tonics is unjustified; some athletes abuse them. ANDROGENS Androgens f
PDF page 832
Conception and contraception Patients planning to conceive should be warned that there is a risk of multiple pregnancy (rarely more than twins). Androgenic effects in women Women should be advised to report any signs of virilisation e.g. deepening of the voice or hirsutism. eiiii F 810
PDF pages 831, 832, 833
50 mg once daily for 5 days, to be started
First-line fragment. Read the complete Indications and Dose section above.
PDF page 831
