Developmental Clinical Studies - Reversing endometrial glucocorticoid deficiency in heavy menstrual bleeding

Heavy periods are literally a monthly 'curse' for millions of women. Menstrual complaints have a broad negative impact on the lives of women - affecting their everyday activities, including work, family life and relationships. Menstrual problems can occur any time between 12 and 55 years of age, but heavy menstrual bleeding (HMB) is most common between 30 and 50 years of age, which is also the stage when women have numerous aspirations, roles and responsibilities, which would be severely curtailed by menstrual complaints. The regular impact of menstruation (about a quarter of a woman's life - 7 days out of 28) can lead to low mood, which can in turn impact further on quality of life and fulfilment of roles. For those in families with low income, the cost of sanitary protection for HMB can also be a recurring burden on the family budget. A million women a year seek medical help for their condition, consuming considerable NHS resource, in terms of consultations with GPs (or attendances at hospital clinics) and tests and prescriptions. Unfortunately the treatments on offer are often ineffective and many women complain of unacceptable side effects. Although hysterectomy can solve the problem of heavy bleeding most women would rather avoid taking this 'irreversible' step which is not surprising as close to half of all babies born in the UK have mothers aged 30 or older . There is therefore an urgent requirement for development of novel, effective, medical treatments for heavy periods. Our plan builds on previous research comparing the lining of the womb in women with and without heavy bleeding. This has provided compelling evidence that the activity of glucocorticoids in the endometrium of women with HMB is deficient..We believe this deficiency results in altered structure of the blood vessels of the womb, which could lead to increased menstrual bleeding. We hope to demonstrate that a glucocorticoid (dexamethasone; Dex), already in common use for other conditions, will reverse the observed endometrial glucocorticoid deficiency, and hence be beneficial in women requesting treatment for HMB. Dex will be given to women in the second half of their menstrual cycle, in the week prior to their expected period (menses) and we expect Dex given over this time period will improve the ability of blood vessels in the endometrium to efficiently constrict when menses commences, and hence reduce menstrual bleeding. While this is a novel use of Dex, it is in wide-spread use eg .glucocorticoids are used to treat medical conditions in early pregnancy including asthma and rheumatoid arthritis. A lot is already known about the side-effects that can occur with Dex and that they depend upon the duration of treatment as well as the dose. This leads us to expect that Dex will be unlikely to be cause problems during the short courses of treatment we plan to use in this study. We hope this new medical treatment will benefit women of reproductive age suffering from heavy bleeding by reducing their blood loss improving their quality of life, allowing them to participate in family activities and avoid time off work. Our beneficiaries will thus be the women, their families and employers, and in terms of costs saved, society and the economy.