These studies have finished recruiting. The main findings can be found below.
The DexFEM study (Dexamethasone for Excessive Menstruation)
WHY was it done? This study built on previous research which has provided evidence that deficient activity of glucocorticoids in the endometrium may contribute to an increase in menstrual bleeding. This study aimed to demonstrate that a glucocorticoid (dexamethasone), already in common use for other conditions, (eg to treat medical conditions such as asthma and rheumatoid arthritis in early pregnancy), will reverse the endometrial glucocorticoid deficiency and as a result reduce menstrual blood loss.
WHAT was involved? The study was in two stages, a 12 month workup stage and a 3 year, response adaptive, dose-finding randomised controlled trial. The first stage involved two workup clinical studies to gather preliminary safety and efficacy data from first-in-Heavy Menstrual Bleeding (HMB) use of oral dexamethasone. It also provided methodological data for a series of simulation studies to determine a robust adaptive trial design specification.
Main findings: Results are being analysed and should be published soon. Watch this space for links to the scientific paper and any media coverage.
The HEALTH study
WHY was it done? Heavy menstrual bleeding (HMB) is a very common and distressing condition which affects over 1.5 million women in the UK. Initial treatment usually involves the use of drugs, including the combined oral contraceptive pill, as well as a hormonal intrauterine contraceptive device. However, many women find these types of treatments unsuitable or unsuccessful and will need surgical treatment.
The aim of the HEALTH study was to provide information on the best surgical treatment for women with HMB in the future. The two procedures being compared were endometrial ablation and laparoscopic supra-cervical hysterectomy. These procedures were compared in over 600 women from NHS hospitals throughout the UK to find out which one offered better relief of their symptoms.
Main findings: Patients who had a keyhole hysterectomy (without removal of the cervix) were more satisfied with their treatment compared to those who had an endometrial ablation procedure. The number of complications was similar for the two procedures, but the hysterectomy surgery took longer to perform and was associated with a longer recovery for the patient.
The PEARL III Study
WHY was it done? To assess the effectiveness and safety of ulipristal acetate as a treatment in women with fibroids.
Main findings: after one 3 month course of ulipristal acetate, approximately 80% of women had no menstrual bleeding. Shrinkage of fibroids was variable in individual women but was down by approximately 45% if women in the middle of the response curve were examined. The lining of the womb did not show any worrying changes when examined during or after treatment.
The WOMB study (Womb Oxygen levels determined by Magnetic resonance imaging and impact on Bleeding)
WHY was it done? Heavy menstrual bleeding (HMB) is a common, debilitating condition. Understanding the process of menstruation may improve treatments for those with problematic periods. The aim of this study to determine if oxygen levels change in the lining of the womb across the menstrual cycle. Women with a normal volume of blood loss during menstruation (<80ml) and not using hormonal medications had an MRI scan and provided a biopsy of the lining of their womb during a period and when they were not menstruating. Markers of low oxygen levels (hypoxia) were measured.
Main findings: A significant change in an MRI marker of hypoxia was found during menstruation, when compared to scans done when participants were not menstruating. Biopsies collected from the lining of the womb during menstruation had increased levels of genes that are switched on in the presence of hypoxia when compared to those collected when not menstruating. These findings suggest the womb lining is exposed to hypoxia during a normal period and that this can be detected by an MRI scan. This low oxygen may trigger the repair process that is necessary to prevent prolonged menstrual bleeding.
The FEMME trial (A Randomized Trial of Treating Fibroids with Either Embolisation or Myomectomy to Measure the Effect on Quality of Life Among Women Wishing to Avoid Hysterectomy)
WHY was it done? Uterine fibroids are common in women of reproductive age and are associated with heavy menstrual bleeding, abdominal discomfort and a reduced quality of life. For women who have not had a good response to tablet-based treatments and who do not want a hysterectomy (surgical removal of the womb), myomectomy (surgical removal of fibroids) and uterine-artery embolization (blocking the blood supply to the fibroids) are treatment options. This study aimed to determine the impact of these procedures on quality of life of women with symptomatic fibroids. 254 women in the UK were randomly assigned to myomectomy or uterine artery embolization. 206 women provided data on their quality of life 2 years following the procedure.
Main findings: At 2 years, those having a myomectomy reported higher quality of life scores than after uterine artery embolization. The complication rates in both groups were similar (myomectomy group = 29%, uterine artery embolization group = 24%).