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Doses of oestrogen and progestogen safety alert

3 April 2023

Joint BMS FSRH RCGP RCOG SfE and RCN Women's Health Forum safety alert.

Joint safety alert from the British Menopause Society, Faculty of Sexual & Reproductive Healthcare, Royal College of General Practitioners, Royal College of Obstetricians & Gynaecologists, Society for Endocrinology and the Royal College of Nursing Women's Health Forum.

This safety alert has been produced in response to questions raised in relation to appropriate doses of oestrogen and progestogen provided to women experiencing symptoms of menopause.

It is important that women requiring treatment are managed safely within established guidelines set out by the National Institute for Health and Care Excellence (NICE), MHRA and national and international guidance. The guidance is to aim for the lowest effective dose to control symptoms.

We are aware of increasing numbers of women being initiated on high doses of oestrogen which exceed the product licenses, not in line with any clinical guidelines. Oestrogen should not be regularly prescribed in doses higher than the upper limit listed in the individual Summary of Product Characteristics (SmPC) as these limits are informed by the results of clinical trials, to ensure patient safety. If in exceptional circumstances a higher than licensed dose is deemed necessary for symptom control, informed consent should be obtained according to good medical practice guidance and patients must be made aware that treatment falls outside of reassuring safety evidence. In addition, the dose of progestogen should be increased proportionately.

Dose finding studies assure that symptom control is achieved within robust safety parameters and all clinical research is bound by Good Clinical Practice1 and the Declaration of Helsinki2. This is to ensure that patient safety remains paramount, and this ethical consideration must continue to influence prescribing of products, including oestrogen, once they are licensed3-5. There is good clinical evidence in relation to the dose of progestogen required, alongside licensed doses of oestrogen, to adequately protect the endometrium against hyperplasia with atypia, a risk factor for endometrial cancer4,6-8. Endometrial cancer is becoming more common in association with rising obesity and effective endometrial protection is more important now than ever. Routine use of minimal/insufficient doses of progestogen should therefore be avoided. Progestogen intolerant patients receiving lower doses of progestogen (with informed consent) require regular endometrial surveillance in specialist centres with direct access to ultrasound, endometrial biopsy, and hysteroscopy if required.

1 Mentz, R.J. et al. (2016) 'Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds', Circulation (New York, N.Y.), 133(9), pp. 872-880.
2 'World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects' (2013) JAMA : the journal of the American Medical Association, 310(20), pp. 2191-2194.
3 Ruan, X. and Mueck, A.O. (2022) 'Primary choice of estrogen and progestogen as components for HRT: a clinical pharmacological view', Climacteric : the journal of the International Menopause Society, 25(5), pp. 443-452
4 Furness, S., Marjoribanks, J., Lethaby, A., Cochrane Library. Hormone therapy in postmenopausal women and risk of endometrial hyperplasia (Review) 2012
5 Feeley, K.M. and Wells, M. (2001) 'Hormone replacement therapy and the endometrium', Journal of clinical pathology, 54(6), pp. 435-440.
6 Sriprasert, I. et al. (2021) 'Use of oral estradiol plus vaginal progesterone in healthy postmenopausal women', Maturitas, 154, pp. 13-19.
7 Hamoda, H. Progestogens and endometrial protection. Tools for clinicians. British Menopause Society
8 Stevenson, J.C. et al. (2020) 'Progestogens as a component of menopausal hormone therapy: the right molecule makes the difference', Drugs in Context, 9, pp. 1-12.

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