Researchers from the Universities of Aberdeen and Edinburgh have been awarded just under £2 million to lead a major clinical trial investigating a promising new treatment for heavy menstrual bleeding, which could transform the lives of millions of women around the world who live with the debilitating 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% 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. 270 participants will have an equal chance of being treated for 12 months with either relugolix-CT or one of the currently available medical treatments. Follow up questionnaires will be used to assess the effect of treatment on quality of life, menstrual symptoms and use of NHS services.
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 the University of Edinburgh, NHS Grampian, Barts Health NHS Trust, Birmingham Women's and Children's NHS Foundation Trust 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 Women’s Health at the University of Aberdeen’s Centre for Women's Health Research and Honorary Consultant Gynaecologist at NHS Grampian 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.”
Professor Hilary Critchley, Professor of Reproductive Medicine at the University of Edinburgh Institute for Regeneration and Repair said: “Heavy menstrual bleeding is debilitating, too often normalised and is under recognised and under researched. This important study will raise awareness and offer a further treatment option to those suffering with HMB.”
Professor Anthony Gordon, Director for NIHR's Health Technology Assessment (HTA) Programme, which is funding the trial, said: "Many women face the difficult and debilitating effects of heavy menstrual bleeding. This trial will help determine whether this new treatment could be a more suitable option for them, and it has the potential to make a significant positive impact on their day-to-day lives.
"Investing in studies like this also forms a key part of our ongoing commitment to becoming a more inclusive funder of research. NIHR celebrates its 20th anniversary this year, and we're proud of the work we've done in the past two decades to help advance women's health research. It's absolutely essential we continue build on that knowledge by funding research and innovation that improves women's health, reduces health inequalities and delivers real benefits for real people."
Dr Su Bunn, Women's Divisional Clinical Director for NHS Grampian, commented: "It is excellent this important issue in women's health research is being prioritised and women in Grampian have a chance to participate. Heavy menstrual bleeding (HMB) has a debilitating effect on quality of life for millions of women worldwide and controlling the symptoms whilst preserving fertility will be life-changing for younger women. The NHS Grampian gynaecology service is delighted to support this important work."