Clinical trial into heavy menstrual bleeding could transform lives
Researchers from our Women’s Hospital are part of a major trial investigating a promising new treatment for heavy menstrual bleeding.
The study could transform the lives of millions of women around the world who live with the debilitating condition.
Led by the University of Aberdeen, which has been awarded just under £2 million to fund the study, our Women’s Hospital will be one of the major recruiters.
Professor Justin Clark, Consultant Gynaecologist at the hospital, said: “I am excited to be involved with this important trial. There is an urgent need for better medical, fertility preserving treatments for women with heavy menstrual bleeding.
“We have a large and diverse patient population in Birmingham and we will be a major contributor to recruiting to this important study.
“If the drug is found to be effective it could make a huge difference to many women’s whose health-related quality of life has been impaired by this condition."
The three-and-a-half-year study, funded by the National Institute for Health and Care Research (NIHR), will investigate whether a new medicine taken as a pill every day could treat the condition more effectively than current medical treatments.
Heavy menstrual bleeding (HMB) affects one in three women and can have a major impact on their lives. Over half of those who live with it are unable to carry out their usual daily activities and 43 per cent have missed work due to their symptoms including bleeding and cramps.
The condition is associated hormonal and clotting disorders, uterine problems such as fibroids and adenomyosis (when the lining of the uterus starts growing into the muscle in the wall of the womb), but the actual cause remains unknown in half of all women.
Current treatment options for HMB, including tablets and the hormonal coil, are either ineffective in many women or come with side effects such as irregular bleeding. As a result, many women who use these treatments can end up resorting to surgery to remove the uterus, making future pregnancies impossible.
The new medicine being tested in this trial, relugolix combination therapy (relugolix-CT), contains relugolix which temporarily stops the monthly menstrual cycle by producing a menopause-like state. Taken as a daily pill, it also contains hormone replacement therapy (HRT) which prevents any menopausal symptoms.
Previous research on women with fibroids has shown relugolix–CT can substantially improve symptoms of HMB without some of the side-effects that come with other hormonal treatments. Women are also able to try for a pregnancy as soon as they stop taking the pill – an option that is impossible for women who have had a hysterectomy to cope with their HMB symptoms.
This clinical trial will test whether relugolix-CT improves HMB in comparison with current medical treatment options.
The study is led jointly by Professors Siladitya Bhattacharya from the University of Aberdeen and Hilary Critchley from the University of Edinburgh. It will be carried out by the University of Aberdeen in collaboration with Birmingham Women's and Children's NHS Foundation Trust, the University of Edinburgh, NHS Grampian, Barts Health NHS Trust, the Royal College of Obstetricians and Gynaecologists and The Lowdown – a research platform for women's health. The research team includes women who have lived experience of HMB.
Professor Siladitya Bhattacharya, Professor of Obstetrics and Gynaecology at the University of Aberdeen’s Centre for Women's Health Research said: “Heavy menstrual bleeding robs women of the chance to realise their full potential in life – the ability to prevent this could change lives. The limited success of currently prescribed drugs forces women to have to choose between coping with some of their symptoms in order to preserve their fertility and opting for surgery which takes away their chance of motherhood. For many of them, this trial could finally offer the chance of a medical treatment which is both effective and reversible.”