ENDOCAN-1: A Pilot Randomised Controlled Trial of the Efficacy of a CBD Oral Tincture in The Mangement of Endometriosis-Associated Pain

ENDOCAN-1 will investigate if a future large scale, UK-wide trial to determine whether a cannabinoid can reduce endometriosis-associated pain is possible. 100 women with pelvic pain due to endometriosis will be randomly assigned to take MRX1 CBD drug candidate or identical placebo for 12 weeks.

Neither the women, nor their medical team, will know what treatment they are taking. Participants will be asked to complete questionnaires about their symptoms. This will help plan a future larger study to determine whether CBD reduces endometriosis-associated pain and provide value for money.

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About Endometriosis and the ENDOCAN-1 study

Endometriosis is a condition that affects up to 10% of women, where tissue similar to the lining of the uterus grows outside the womb, such as on the ovaries and fallopian tubes. This can lead to chronic pelvic pain, infertility, and a significant reduction in quality of life. Many women with endometriosis endure severe and debilitating symptoms that can impact their daily lives, careers, and mental health, often for years before receiving an accurate diagnosis.

Currently, the absence of a reliable diagnostic marker means that, in the UK, it takes an average of 8 years to diagnose this inflammatory condition. Surgery is the only definitive diagnostic method, but even with surgery, there is no cure available.

Women with endometriosis often endure chronic pain for many years. In the United States, pain is commonly managed with medications like ibuprofen or paracetamol, and in more severe cases, opioids. There is an urgent need for alternative pain management solutions.

Treatment options for endometriosis typically include surgical removal of lesions or hormone therapy similar to contraceptive pills.

Cannabidiol (CBD) is a compound with various properties that show promise in addressing both the symptoms and underlying mechanisms of endometriosis. CBD has anti-inflammatory, analgesic, anxiolytic, antidepressant, and several other therapeutic effects. It interacts with over 65 different receptors and mechanisms in the body, some of which involve the endocannabinoid system (ECS).

The ECS plays a critical role in maintaining balance in the body, influencing functions such as memory, neurogenesis, mood regulation, appetite, metabolism, stress response, immune function, reproduction, pain management, temperature regulation, and sleep.

Research has indicated that cannabis consumption can effectively relieve pelvic pain and may already be a valuable part of endometriosis pain management strategies.

Ananda's patent-pending CBD formulation, MRX1, is currently being evaluated in ENDOCAN-1, a pilot study focused on managing endometriosis-associated pelvic pain.

The results from ENDOCAN-1 will be instrumental in planning larger clinical trials to further investigate the potential of CBD in treating endometriosis.

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Trial Team:

Professor Andrew Horne (MB ChB, PhD, FRCOG, FRCP Edin, FRCSEd, FRSE, FMedSci

Andrew is Director of the Centre for Reproductive Health at the University of Edinburgh.  He is a leading researcher in women’s health problems, with a focus on endometriosis and pelvic pain, and has published over 200 peer-reviewed scientific articles. He is President-elect of the World Endometriosis Society and Trustee to Endometriosis UK.

Andrew has a vision that ultimately all medical interventions for women with endometriosis will have an underlying evidence base, demonstrating that their action does more good than harm. In case of uncertainty, he believes that patients must be informed of the evidence gap, and optimally, be offered participation in a clinical trial.

To achieve this goal, he has established EXPPECT Edinburgh. EXPPECT brings together individuals involved in the clinical care of women with pelvic pain and endometriosis with discovery scientists to form a hub within which innovative approaches to pelvic pain treatment can be developed in collaboration with commercial partners.

Professor Philippa Saunders (PhD, FmedSci, FRSE, FCOG ad eudem)

Philippa Saunders is Professor of Reproductive Steroids at the University of Edinburgh and co-Director of the EXPPECT Centre which brings together discovery scientists and clinicians conducting research to improve diagnosis and treatment of endometriosis.

Her current research is focused on increasing our understanding of the ways in which sex steroids, their receptors and downstream signalling pathways, regulate reproductive and other tissues. Her studies on endometrial function include seminal contributions on the role(s) of androgens, insights on mechanisms of scarless healing and translational studies focused on finding new strategies to reduce endometriosis-associated symptoms including pain.

Dr Lucy Whitaker (BSc(hons) MB ChB MSc MD MRCOG)

Lucy’s research focuses on the management of chronic debilitating conditions across the reproductive life-course, including chronic pelvic pain, endometriosis and abnormal uterine bleeding.

Pelvic pain is responsible for a third of all unscheduled admissions to gynaecology. Many of these patients have underlying endometriosis, a chronic neuroinflammatory pain condition affecting ~190 million women worldwide, a similar prevalence to diabetes in women. As well as resulting in high use of unscheduled care resources, pelvic pain ‘flares’ contribute to decreased physical and mental health and reduced work and education participation. Endometriosis is poorly managed and costs the UK £12.5 billion every year in socioeconomic costs.

Lucy’s research theme is focused on translational research towards precision treatments for pelvic pain. It encompasses the investigation of new diagnostic approaches, potential for patient stratification and prediction of treatment response using clinical/biological data profiles from women with endometriosis and a programme of drug repurposing and surgical trials to produce rapid change in national clinical guidelines and improvement in patient's symptoms and quality of life.