Clinical studies

Our current clinical studies, finding ways through research to improve reproductive health.

ADVANTAGE

Trial Lead: Frances Collins

About this study

One in twenty individuals in the UK are disabled by visceral pain - approximately as many people as live in the entire country of Wales. The condition is a terrible burden for those who suffer from it: causing pain not only during the most intimate moments of their lives, but also frequently triggering unpredictable episodes of pain "flares" that can need hospital admission. 

There are many conditions associated with visceral pain including: chronic pancreatitis, chronic pelvic pain syndrome, endometriosis, inflammatory bowel disease, painful bladder syndrome, autosomal dominant polycystic kidney disease and vaginal mesh surgery. 

This study is a collaboration between expert patients and clinicians, clinical and pre-clinical pain researchers, engineers, and industrial collaborators who are working together to try to develop new drugs and treatments – specifically tailored for chronic visceral pain. 

We will be looking for people with chronic visceral pain, particularly those who have severe pain despite few signs of disease. We will also look for those who feel little no or pain despite advanced disease. We will record their pain using standard questionnaires but will also explore other ways to capture their experience; for example, using online apps and body sensors to record physical activity and physiological changes, for example heart rate, throughout the day. We hope to discover genes in humans that control pain. We also look to see if the immune system is involved. 

Our aim is to improve our understanding of visceral pain from the perspective of people living with the condition, so that the NHS can develop and offer patients more effective interventions and support to address the diverse nature of their symptoms and help improve their quality of life.

This trial is currently recruiting.

ENDOCAN-1

A pilot randomised controlled trial of the efficacy of a cannabinoid oral tincture in the management of endometriosis-associated pain (2023-2026)

Trial Lead: Frances Collins and Lucy Whitaker

EndoFLARE

Improving understanding of endometriosis pain flares to support patients with self-management and prevention (EndoFLARE): a feasibility study (2023-2024)

Trial Lead: Frances Collins and Lucy Whitaker

EPiC2

A randomised, double-blind, placebo-controlled feasibility trial to evaluate dichloroacetate in the management of endometriosis-associated pain (2023-2026)

Trial Leads: Lauren Sutherland and Andrew Horne

ESPriT2

A multi-centre randomised controlled trial to determine the effectiveness of laparoscopic treatment of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (2021-2026)

Trial Leads: Andrew Horne and Lucy Whitaker

About the study

Endometriosis (where cells similar to the womb-lining are found outside the womb) affects~176 million women worldwide and can lead to debilitating pelvic pain. Three subtypes of endometriosis exist, with ~80% of women having ‘superficial peritoneal’ endometriosis (SPE). Endometriosis is diagnosed by keyhole surgery (laparoscopy) and, if SPE is found, gynaecologists usually remove it surgically.

However, many women get limited pain relief from surgical removal of SPE. We therefore plan to undertake a multi-centre trial across the UK where women who have only SPE found at laparoscopy are randomly allocated to have surgical removal or not to have it removed. We want to determine whether surgical removal improves overall SPE symptoms and quality of life, or whether surgery is of no benefit, exacerbates symptoms, or even causes harm.

ESPriT2 logo

If you would like to take part in ESPriT2, please look to see if you are being cared for by one of our recruiting centres. If you are, then please talk to your care team to see if you can take part. More information can be found on the ESPriT2 website.

MAC-Endo 

A proof-of-concept and feasibility study of macrophage-targeted immunotherapy in the management of endometriosis-associated pain (2024-2026)

Trial Lead: Ann Doust and Andrew Horne

REGAL

Recurrence of Endometriosis: A randomised controlled trial of clinical and cost-effectiveness of Gonadotrophin Releasing Hormone Analogues with add-back hormone replacement therapy versus repeat Laparoscopic surgery

Trial Lead: Christine Kennedy

About the study

Endometriosis is diagnosed by laparoscopy (keyhole surgery) which identifies areas of endometriosis which can then be destroyed or removed. However, surgery rarely provides lasting relief and pain can return in up to half of treated women within five years. To reduce the chance of regrowth of endometriosis and recurrence of pain, women who are not trying to get pregnant are offered the combined oral contraceptive pill or other contraceptives containing hormones called progestogens. Despite this, about one in three women will require more operations to treat endometriosis that has come back. 

A less invasive way of shrinking endometriosis is to use a drug called Gonadotrophin Releasing hormone analogue (GnRHa) which temporarily stops the ovaries from producing oestrogen. While very effective in terms of reducing pain, this treatment has only been used for up to a year because of side effects such as hot flushes and night sweats and concerns about osteoporosis (thinning of the bones). Recent research has shown that adding small doses of hormone replacement therapy (HRT) in women on GNRHa reduces the risk of side effects and osteoporosis whilst controlling the pain. 

REGAL trial is comparing long-term GnRHa with added HRT to further keyhole surgery for treatment of endometriosis in women who experience recurrence of pain after surgery but wish to preserve their fertility. 

This study is currently recruiting.

STOPPIT-3

A Randomised Placebo-Controlled Trial of Antenatal Corticosteroids for Planned Birth in Twins

Trial Lead: Denise Cranley

About the study

This trial aims to find out if medicines called antenatal corticosteroids (ACS) given to women with a twin pregnancy prior to a planned birth of twins after 35 weeks of pregnancy reduces breathing difficulties in the twin babies.

This trial is organised and sponsored by the University of Edinburgh and NHS Lothian. It will run in NHS centres throughout the UK and we will need around 1,550 women to take part in the trial to be able to see how ACS works in twins.

Women who attend a hospital running the trial and fit the eligibility criteria below may be approached by their clinical team to participate. The women’s obstetrician or a member of the midwifery team will discuss the trial with the women and decide if they can and want to take part. 

STOPPIT-M

STOPPIT-M is linked to the main STOPPIT-3 trial. This study will only be recruiting women pregnant with twins with a planned caesarean birth scheduled between 35+0 and 38+6 weeks gestation enrolled in the STOPPIT-3 trial.

Trial Lead: Denise Cranley

About the study

In this study, we will aim to explore how antenatal corticosteroids (ACS) work and why responses to ACS vary between babies. The main trial STOPPIT-3 aims to resolve uncertainty about whether ACS given to women with a twin pregnancy reduces breathing complications in twin babies.

In STOPPIT-M, we want to understand why ACS work for some babies, but other babies still develop problems. We know that ACS can directly cross the placenta and reach the baby. We think that ACS may “damp down” the babies own ‘stress response’ systems and that this may be the reason why some babies have problems such as breathing difficulties and low blood sugar levels.

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