ENDOCAN-1: A feasibility randomised controlled trial of the efficacy of a cannabinoid oral solution in the management of endometriosis-associated pain

Background and study aims This study, funded by the Chief Scientist Office (CSO) will use a solution called MRX-1 which is a cannabinoid solution that does not contain THC which we will use to see if it reduces pain in patients with endometriosis. Endometriosis is a condition that affects 1 in 10 women or those assigned female at birth and causes pain, infertility and can reduce quality of life. At the moment available drug treatments have unacceptable side effects and are often hormonal and are contraceptive. There is an unmet need to find new treatments . Cannabinoids have been shown to be effective in other pain conditions. Who can participate? We will recruit 100 women over a period of 18 months from NHS Lothian and NHS Grampian. What does the study involve? This study will involve 5 hospital visits over a period of 17-18 weeks. Once eligibility has been confirmed the participant will be selected by chance (randomised) to have either the trial solution or placebo solution. The solution will be dosed according to the participant's weight and the dose can be increased weekly up to a maximum of 6.25mg/kg twice daily. They will take the solution for a 12 week period. We will collect questionnaires to assess pain scores and quality of life information. This study will help us develop a larger multi centre study. We will also ask participants in Edinburgh to wear a smartwatch during their participation (optional). What are the possible benefits and risks of participating? Participants may or may not benefit from taking part in this trial, however the results from this trial might help to improve the healthcare of patients with endometriosis in the future. Participants may also feel some improvement in their pain symptoms. The patient might experience some side effects caused by the study solution. If they experience intolerable side effects they can either reduce the dose they are taking or stop. Questionnaires where possible can be completed online at home to reduce the time burden on patients. The participants will have blood samples taken which might cause discomfort and bruising but this will be taken by a trained member of the research team. Where is the study run from? University of Edinburgh (UK) When is the study starting and how long is it expected to run for? September 2026 to March 2028 Who is funding the study? Chief Scientist Office, Scottish Government Health and Social Care Directorate (UK) Who is the main contact? ETMT@ed.ac.uk