Completed studies

Our Studies

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: This trial of dexamethasone tablets (1·8 mg daily over 5 days in the second half of the menstrual cycle) in those with heavy menstrual bleeding reduced menstrual blood loss.

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Menstrual disturbance after Acute COVID or COVID vaccination

WHY was it done? People were reporting menstrual disturbance during the COVID pandemic and after COVID-19 vaccination. This study aimed to tease out the associations between acute COVID and COVID vaccination and menstrual disturbance.

WHAT was involved? Researchers from Edinburgh, Oxford, Montpellier, Bristol and Exeter investigated results from a survey conducted in the UK in March 2021. Participants were asked about any menstrual changes during the pandemic, their COVID vaccination history and whether they had every had COVID-19. Almost 5000 premenopausal participants had been vaccinated against COVID-19. Of 12000 participants, 3635 had been vaccinatated but never had COVID, 1802 had not been vaccinated but had contracted COVID and 5788 had neither.

Main findings: 82% reported no menstrual changes after COVID vaccination. Of the 18% of participants who did, the risk was higher in those who smoked, had previous COVID-19 or were not using an estrogen containing pill. Compared to those not vaccinated and never had COVID-19, vaccination alone did not show increased abnormal menstrual parameters (regularity, duration, volume). Those with a history of COVID-19 were, however, at increased risk of menstrual disturbance.

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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.

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Other Studies

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.

https://www.bbc.co.uk/news/health-49676883

1. Read the publication from this study

2. Read the publication from this study

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.

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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%).

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The LIBERTY Study: Treatment of uterine fibroid symptoms with relugolix combination therapy.

WHY was it done? To investigate how effective this tablet-based treatment was in treating heavy periods due to fibroids. Approximately 700 women took part and were given relugolix alone, relugolix in combination with hormone replacement therapy (HRT containing oestradiol and progestogen) or placebo (a sham tablet). Neither the women or the investigators knew which tablet was being taken until the end of the trial.

Main findings: About 70% of women taking relugolix (either with or without HRT) had a significant reduction in menstrual bleeding when compared to those taking the placebo. Those taking relugolix alone had lower bone mineral density than those on placebo but this was not seen in those taking relugolix with combined HRT.

Read a statement from NICE about this medication

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Read a review of the study findings