A University of Aberdeen-led research team has secured almost £2 million to investigate whether a daily pill could provide a more effective, fertility-preserving treatment for heavy menstrual bleeding.
The three-and-a-half-year clinical trial, funded by the National Institute for Health and Care Research (NIHR), will compare relugolix combination therapy (relugolix-CT) with existing medical treatments for the condition. The study will be jointly led by Professor Siladitya Bhattacharya of the University of Aberdeen and Professor Hilary Critchley of the University of Edinburgh.
Heavy menstrual bleeding affects around one in three women. More than half of those affected are unable to complete their usual daily activities, while 43 per cent report missing work because of symptoms including severe bleeding and cramps.
The condition can be linked to hormonal or clotting disorders, fibroids and adenomyosis, although its cause is unknown in around half of cases. Current options, including tablets and the hormonal coil, can be ineffective or result in side effects such as irregular bleeding. Some women ultimately undergo a hysterectomy, which prevents future pregnancy.
Relugolix-CT is a once-daily treatment containing relugolix, which temporarily suppresses the monthly menstrual cycle, alongside hormone replacement therapy intended to prevent menopausal symptoms. Earlier research among women with fibroids found the treatment could substantially improve heavy menstrual bleeding symptoms without some side effects associated with other hormonal treatments.
The trial will recruit 270 participants, who will have an equal chance of receiving relugolix-CT or an existing medical treatment for 12 months. Researchers will use follow-up questionnaires to assess impacts on menstrual symptoms, quality of life and use of NHS services.
Professor 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.
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“The limited success of currently prescribed drugs forces women to choose between coping with some of their symptoms 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 Critchley, Professor of Reproductive Medicine at the University of Edinburgh’s Institute for Regeneration and Repair, added: “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.”
The University of Aberdeen is delivering the research alongside the University of Edinburgh, NHS Grampian, Barts Health NHS Trust, Birmingham Women’s and Children’s NHS Foundation Trust, the Royal College of Obstetricians and Gynaecologists, and women’s health research platform The Lowdown. The team also includes women with lived experience of heavy menstrual bleeding.
