Joint safety alert: appropriate doses of oestrogen and progestogen provided to women experiencing symptoms of menopause (3 April 2023).

Summary

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.

Content

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.

There are 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 Practice and the Declaration of Helsinki. 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 licensed. 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 cancer. 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.