At the beginning of February, the Medicines and Healthcare products Regulatory Agency UK launched a public consultation regarding the reclassification of vaginal oestradiol (Gina 10 µg tablets) to make it available from pharmacies1. This announcement was published widely across news outlets in the UK with some reporting that ‘hormone replacement therapy could be available over the counter’2.
'Although in the UK the average age of onset of menopause is 51 years, premature ovarian insufficiency affects approximately 1% of the female population.'
Hormone replacement therapy (HRT) involves the administration of hormones after the menopause, and aims to both relieve symptoms and protect against side effects of hypo-oestrogenism, including increased cardiovascular events and reduced bone mineral density. HRT typically includes the replacement of oestrogen either in isolation (for women without a uterus) or in combination with progesterone and, for some individuals, testosterone supplementation.
Estimates suggest that 85% of women experience at least one menopausal symptom during their lifetime3. Whilst vasomotor symptoms are the most widely reported, genitourinary syndrome of menopause, characterised by vaginal dryness, dyspareunia and recurrent urinary tract infections has been recently been observed in 37% of women aged 40–55 years in a cross-sectional study in Italy 4.
Although in the UK the average age of onset of menopause is 51 years, premature ovarian insufficiency (POI, loss of ovarian function <40 years of age) affects approximately 1% of the female population. Additionally, it should be noted that the menopause may occur due to either loss of intrinsic ovarian function or as a result of medical treatments (including surgical removal of the ovaries, bilateral oophorectomy, or chemotherapeutic agents).
The menopause has recently risen in public awareness following a series of high-profile campaigns and programmes. In a survey of 846 women aged 40–65 conducted by Ipsos MORI in 2020, 47% had experienced 3 or more symptoms whilst at work, and half of these women felt that this had negatively impacted their work5. Additionally an earlier survey undertaken by Ipsos MORI on behalf of the British Menopause Society (BMS) in 2016 revealed that one in two women had not consulted a healthcare professional for their menopausal symptoms, despite 42% saying that they were worse than expected6. It therefore is unsurprising that some have welcomed this news regarding the potential availability of a form of HRT from pharmacists for symptomatic relief.
'For patients experiencing more widespread symptoms, a consultation between the patient and clinician remains important.'
Vaginal oestradiol is typically administered once daily for two weeks on initiation, and then twice weekly thereafter and can provide important relief from genitourinary symptoms. However low-dose vaginal oestradiol has minimal systemic absorption and as such it is not an effective treatment for symptoms including hot flushes, reduced libido and cognitive function. For these, other preparations of HRT, including either oestrogen alone (in women without a uterus) or in combination with progesterone are required, the selection of which requires a careful appraisal of individual patient characteristics and discussion with the patient to determine the most appropriate mode of delivery.
In summary, the potential availability of vaginal oestradiol reflects an increasing awareness of the prevalence of menopausal symptoms and the desire to improve access to treatment. However, for those patients experiencing more widespread symptoms, a consultation between the patient and clinician remains important in evaluating both the symptoms being experienced and the most suitable form of HRT to provide relief.
Sophie Clarke
Consultant Endocrinologist, University College London Hospital
REFERENCES
1. Medicines and Healthcare products Regulatory Authority. 2022 Open consultation: Proposal to make Gina 10 microgram vaginal tablets (Estradiol) available from pharmacies. https://www.gov.uk/government/consultations/consultation-on-proposal-to-make-gina-10-microgram-vaginal-tablets-estradiol-available-from-pharmacies/proposal-to-make-gina-10-microgram-vaginal-tablets-estradiol-available-from-pharmacies. Accessed 16 February 2022.
2. Sky News. 2 Feb 2022 Menopause: Hormone replacement therapy could become available over the counter. Available at: https://news.sky.com.
3. Woods NF and Mitchell ES. 2005 Symptoms during the perimenopause: Prevalence, severity, trajectory, and significance in women’s lives. The American Journal of Medicine 118(12 SUPPL. 2) 14–24.
4. Cagnacci A at al. 2019 Vaginal atrophy across the menopausal age: results from the ANGEL study. Climacteric 22 85–89.
5. Ipsos MORI 2020. Menopause in the workplace. Ipsos MORI. doi:10.12968/denn.2021.17.12.586.
6. BMS 2016 Are women suffering in silence ? New survey puts spotlight on significant impact of menopause despite recent guideline. British Menopause Society. Available at: https://thebms.org.uk/wp-content/uploads/2016/05/FINAL_BMS-2016-Annual-Conference_Press-Release_060516.pdf [Accessed 23 February 2022]
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