Researchers from NICM Health Research Institute are seeking participants to be involved in a clinical trial investigating the efficacy and safety of two different medicinal cannabis products in people with endometriosis. The study will explore whether medicinal cannabis helps with pelvic pain severity, fatigue, quality of life, and mental wellbeing.

The trial will involve 126 patients, living in New South Wales, who will be monitored by researchers to learn whether medicinal cannabis improves outcomes for people with endometriosis.

Woman_lying_down_in_pain

 

Who can participate?

You may be eligible to participate if:

  • You have endometriosis (confirmed either via laparoscopy, MRI or ultrasound),
  • Live in New South Wales, and
  • Are 18 years of age or older.

Please note that you will not be able to drive a car for up to 6 months while participating in the study.

What does the research involve?

After an initial assessment and consent, participants will:

  • Have blood taken to assess your liver and kidney function.
  • Have a deep endometriosis ultrasound to observe any endometriosis lesions.
  • Complete a series of questionnaires on a mobile phone app to assess your endometriosis symptoms.
  • Be randomly allocated into one of the two treatment groups (a balanced CBD:THC oil or CBD-only oil), or a placebo group.
  • Complete a three-week dosage phase to determine the best daily dose for your levels of pain.

Over the six-month active phase of the study, participants will be asked to:

  • Follow the instructions for the investigational products as directed on the label and by the research staff.
  • Complete a regular, short questionnaire as prompted by the mobile phone app.
  • Have a blood test to monitor your kidney and liver function.
  • If selected, have another ultrasound scan to monitor your endometriosis.

Over the 12-month period after treatment:

  • Have blood taken to monitor liver and kidney function.
  • Complete a regular questionnaire on a mobile app.
  • If selected, have another ultrasound scan to monitor your endometriosis.
  • If selected, complete a one-on-one interview about your experience in the trial.

How do I get involved?

If you would like to know more about the study, please click on the link below or contact us at endocanntrial@westernsydney.edu.au

Click here