Heavy menstrual bleeding (HMB) affects at least 1 in 3 women and is associated with iron deficiency anaemia and reduced quality of life. Due to the risks associated with surgical management, the long NHS waiting lists for surgical treatment and the preference of some women to avoid an operation, there is currently an unmet need for more effective, acceptable, fertility-preserving medical treatments.
Relugolix combination therapy (Relugolix-CT) is a once-daily oral tablet that suppresses ovarian hormone production while including add-back hormone therapy to protect against menopausal side effects. Currently licensed for women with uterine fibroids and endometriosis, there is promising evidence that it may be effective for HMB more broadly.
RESPONSIBLE is a two-arm, multicentre, open-label, pragmatic randomised controlled trial, funded by NIHR HTA (NIHR170575), which aims to compare Relugolix-CT with usual NICE-recommended medical treatment in 270 pre-menopausal women with HMB over 12 months.
The primary clinical outcome is condition-specific quality of life, measured using the Menorrhagia Multi-Attribute Scale (MMAS) at 12 months.
The RESPONSIBLE trial is led by Chief Investigator Professor Siladitya Bhattacharya, based at the University of Aberdeen, and Co-Chief Investigator Professor Hiliary Critchley based at the University of Edinburgh.
The trial is expected to open to recruitment late 2026. If you are interested in becoming a study site, please contact the Trial Manager at responsible@abdn.ac.uk.
Contacts
- Alyson Macneil; responsible@abdn.ac.uk