EndoCann Study
Do you experience endometriosis-related pain and associated symptoms?
NICM Health Research Institute’s Associate Professor Mike Armour is leading the EndoCann Trial.
The research team are seeking participants to be involved in a clinical trial examining the efficacy and safety of two different medicinal cannabis interventions in people with endometriosis and associated pain. The study will also explore if the tested interventions reduce other symptoms of endometriosis, improve quality of life, and effect endometriosis lesion size.
Endometriosis a chronic inflammatory condition characterised by the presence of endometrial-like tissue outside of the uterus in the form of lesions. Many people with endometriosis find it difficult to achieve good pain and symptom control with conventional treatment strategies. Due to poor pain control, people with endometriosis turn to self-managing symptoms, including using cannabis.
The research team will be testing a CBD only oil compared to a balanced THC:CBD oil. The third group will receive a placebo oil that looks and tastes the same as CBD oil but doesn’t have any active components. All products will be provided free of charge.
The majority of the information captured in the trial will be collected online via an app. Participants in the trial will also be required to have a consultation with a medical doctor, blood tests for safety, and undergo a special type of ultrasound (tVUS) to visualise endometriosis lesions. There is also the opportunity for participants to have further ultrasounds throughout the study to track your endometriosis lesions over time. We will also invite eligible people to undergo cognitive testing to better understand the effects of medicinal cannabis.
Who can join?
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People aged 18 years and over, who:
- Are currently living in Australia;
- Have a confirmed diagnosis of endometriosis via one of the following laparoscopy, MRI or Ultrasound imaging by a medical doctor with input from a specialist with specific endometriosis expertise;
- Have not used any form of cannabis (including CBD products) in the previous three-months;
- Report no current, or history of, hazardous cannabis use, or dependency;
- Are not pregnant, breastfeeding or planning to become pregnant in the next six-months;
- If sexually active and pregnancy is a possibility, agree to using appropriate contraception throughout the trial period;
- Have not had endometriosis-related surgery in the previous six months and do not have any surgery planned during the study period;
- Have not started, stopped, or had a significant change in dosage of any medication used to manage endometriosis symptoms in the last three months;
- Agree to not drive or operate heavy machinery while taking the medicinal cannabis products;
- Possess a smartphone or tablet with internet connectivity
What's involved?
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After an initial assessment and consent, you will:
- Have an appointment with a medical doctor to confirm you are suitable to take medicinal cannabis.
- Have blood taken to assess your liver and kidney function.
- Complete a series of questionnaires online to assess your current level of endometriosis related pain and other symptoms.
- Have an ultrasound to measure your endometriosis lesions.
- If eligible, undergo cognitive function testing.
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Participants will then be randomly allocated into one of the two treatment groups (CBD only oil or balanced THC:CBD oil), or a placebo group. Over six-months, you will be asked to:
- Complete a two-week dosage phase to determine the best daily dose for your levels of pain.
- Follow the instructions for the investigational products as directed on the label and by research staff.
- Complete a short questionnaire weekly via an app downloaded on your smartphone or tablet.
- Have blood taken twice to assess your liver and kidney function.
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After treatment participants will be followed-up for one year. During the 12-months, you will be asked to:
- Have blood taken to monitor liver and kidney function.
- Complete a monthly questionnaire to assess pain and other endometriosis symptoms.
- Have two optional ultrasounds to measure your endometriosis lesions.
- If eligible, undergo cognitive function testing.
- Participate in an optional interview to provide feedback on the trial.
What are the benefits for participating?
Participation in this study may help you to manage symptoms of endometriosis. However, please be aware that since there are few similar studies of medicinal cannabis in endometriosis, there may be no direct benefit to you from participating in this study. While the intervention we are testing was found useful in other patient populations, there is no guarantee it will be effective in people with endometriosis. However, this project may benefit the wider endometriosis community. It is likely to provide necessary data to design better treatments for people with endometriosis.
Interested in participating?
For more details about this study please read the following information before deciding on whether to participate.
In order to confirm your eligibility and register your interest, please complete the online form below.
If you have further questions, please contact:
Millie Mardon
NICM Health Research Institute, Study Investigator – Postdoctoral research fellow
Email: endocanntrial@westernsydney.edu.au
Human Research Ethics Committee Approval: This clinical trial has been approved by the Western Sydney University Human Research Ethics Committee (Approval Number: H15775 ).
This study is supported by a philanthropic grant by the Wilson Foundation.
NICM Health Research Institute Chief Investigator: Associate Professor Mike Armour.