RecruitingPhase IIInterventional

ENDOCAN-1: A study to see if CBD (cannabinoid) can help with endometriosis-related pain

The ENDOCAN-1 study is exploring if a particular liquid medicine, MRX1, derived from cannabis (specifically CBD without THC), can help manage pain caused by endometriosis. Endometriosis is a common condition affecting many women, causing pain and impacting their lives, and current treatments often have unwanted side effects. Researchers hope to find new, effective ways to reduce this pain. This study will involve 100 women from NHS Lothian and NHS Grampian over 18 weeks. Participants will either receive the MRX1 medicine or a dummy medicine, taking it for 12 weeks. Researchers will track pain levels and quality of life using questionnaires. The information gathered will help design a larger study in the future, potentially leading to better treatments for endometriosis pain.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

University of Edinburgh and NHS Lothian

Enrolment target

100

Start

01 Jun 2026

Estimated completion

30 Sep 2027

Endometriosis

What is this study about?

Endometriosis is a condition where tissue similar to the lining of the womb grows outside of it, causing significant pain, fertility problems, and generally impacting a woman's quality of life. It affects about 1 in 10 women or those assigned female at birth. Unfortunately, many current pain relief options for endometriosis have side effects or specific uses, like affecting contraception, which means there's a strong need for new and better treatments.

This study, named ENDOCAN-1, is looking at a substance called CBD (cannabidiol). CBD comes from the cannabis plant but does *not* contain THC, which is the part that makes you feel 'high'. Scientists have found that substances like CBD might be helpful for other pain conditions, so this study is testing if it can specifically help with endometriosis-related pain. The medicine being tested is a special liquid solution called MRX-1.

The main goal of this study is to see if MRX-1 can reduce pain in women with endometriosis. The information gathered will be crucial. If it shows promise, it could lead to bigger studies and eventually offer a new and much-needed treatment option for women living with this challenging condition. This could improve their daily lives and help manage their pain more effectively.

Key takeaways

This study evaluates CBD (MRX1) for endometriosis pain relief.
It aims to find new, non-hormonal treatment options.
Participation involves 5 visits over 17-18 weeks.
You might receive the active medicine or a dummy medicine.
Results could help many women with endometriosis in the future.

Who may be eligible?

To join this study, you need to be a woman or someone assigned female at birth, aged 18 or older. You must have been diagnosed with endometriosis through a keyhole surgery (laparoscopy) or scans within the last ten years.

Also, you should have experienced pelvic pain that you've reported for over six months, with your worst weekly pain score being at least 4 out of 10 on two or more occasions in the month before you might join the study. It's important that you are willing not to use any other cannabis products during the study and, if needed, are happy to use effective contraception. You'll also need to be able to understand and agree to take part, and be contactable by text message.

You cannot join if you are pregnant, breastfeeding, or actively trying to get pregnant. If you are past menopause (no periods for more than a year and not using hormones to stop them, or if you've had both ovaries removed), you won't be able to participate. The study also cannot accept you if you've had severe depression or thoughts of self-harm in the past year, or if you've used other cannabis products recently. Certain health conditions like severe liver problems or chronic alcohol abuse, or taking specific medications (Sodium Valproate, Clobazam, Stiripentol, Everolimus), would also prevent you from joining. Finally, if you're already in another clinical trial, you won't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman or assigned female at birth?
Are you 18 years old or older?
Have you been diagnosed with endometriosis in the last 10 years?
Do you experience ongoing pelvic pain?
Are you able to avoid other cannabis products during the study?
Are you not pregnant, breastfeeding, or actively trying to conceive?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have five hospital visits spread out over about 17 to 18 weeks. Once the team confirms you're suitable, you’ll be randomly assigned, like flipping a coin, to receive either the active study medicine (MRX-1) or a dummy medicine (placebo). You won't know which one you're getting.

The medicine is a liquid solution that you'll take for 12 weeks. The amount you take will be based on your weight, and the dose might be slowly increased each week, up to a maximum amount twice a day. Throughout the study, you'll fill out questionnaires to tell us about your pain levels and how your quality of life is. If you live in Edinburgh, you might also be asked if you'd like to wear a smartwatch during your participation, but this is optional. We will also take some blood samples, which will be done by a trained nurse or doctor.

Potential risks and benefits

You might or might not directly feel better from taking part in this study, but your contribution is very important. The results could help develop better treatments for endometriosis in the future, benefiting many other people. You may also notice some improvement in your pain symptoms. There's a chance you might experience some side effects from the study medicine. If these are too bothersome, you can reduce your dose or stop taking the medicine completely. Blood tests, which will be part of the study, might cause some temporary discomfort or bruising. You are always free to leave the study at any time.

Locations (2)

Royal Infirmary of Edinburgh
Approximate
Edinburgh, Scotland
Aberdeen Royal Infirmary
Approximate
Aberdeen, Scotland

Common questions

What is the study trying to find out?

It's investigating whether a CBD-based liquid medicine (MRX1) can reduce pain in women with endometriosis.

Will I get 'high' from the study medicine?

No, the medicine MRX1 contains CBD but does not have THC, which is the part of cannabis that causes a 'high'.

How long will I be involved in the study?

You'll be involved for about 17-18 weeks in total, with 5 hospital visits and taking the medicine for 12 weeks.

Where is the study happening?

The study is being run from the University of Edinburgh and involves hospitals in NHS Lothian and NHS Grampian.

Who is paying for this study?

The study is funded by the Chief Scientist Office, which is part of the Scottish Government.

How to find out more

- ENDOCAN-1 Trial Team

ETMT@ed.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.