Medicinal cannabis for endometriosis: The EndoCann Trial

Phase 2

Recruiting

• Conditions: Endometriosis; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Reproductive Health and Childbirth - Menstruation and menopause; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12624000328572
• Lead Sponsor: Western Sydney University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

Aged over 18 years.
- Self-reported pelvic pain, severe enough to seek medical attention.
- Diagnosis of endometriosis via laparoscopy (with or without histological confirmation), magnetic resonance imaging (MRI), or Ultrasound imaging by a medical doctor, with input from an imaging specialist with specific endometriosis expertise.
- Have not used illicit cannabis and/or prescribed cannabinoid-based medications in the previous three months.
- Report no current, or history of, hazardous cannabis use, or dependency.
- If sexually active and pregnancy is a possibility, agree to use appropriate contraception to prevent pregnancy during the study period.
- Agree to keep all study product stored in a secure location and not to share/distribute cannabis to any other individual.
- Agree not to drive while under the effects of medicinal cannabis.
- Willing to provide informed consent and adhere to the protocol.
- Residing in New South Wales during the trial period.
- Able to travel to NICM Health Research Institute, The Royal Hospital for Women, Sydney Endometriosis, and Macquarie University for data collection.
- Able to travel to a Laverty collection centre for blood tests.
- Has internet access (either via a mobile (Apple or Android) or tablet (Apple)) for logging outcomes via the OnTracka app.
- Ability to understand and speak English.

Exclusion Criteria

- Have had endometriosis-related surgery in the previous six months or have any surgery planned during the study period.
- Started, stopped, or had a significant change in dosage of any endometriosis specific medication in the last three months. This includes contraceptives, GNRH-a, and neuroleptics (changes in ‘as needed’ medications such as analgesics are not reasons for exclusion).
- Have any current or past diagnoses that would be considered a risk to participation in the study, including but not limited to, schizophrenia spectrum and other psychotic disorders, bipolar-related disorders, dissociative disorders, personality disorders, cannabis use disorder, obsessive-compulsive related disorders, neurological disorders, or brain injury.
- Currently have any major haematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal (particularly hepatic), renal, or neurological disease (determined by the medical monitoring team).
- Current usage of anticoagulants (e.g., warfarin, heparin or any other NOAC/DOAC medications) or any other medication, including supplements (e.g., vitamin E, Gingko), that causes blood thinning.
- Currently pregnant or breastfeeding or planning on becoming pregnant during the study period.
- Abnormal liver and kidney function tests as determined during screening process.

Study & Design

• Study Type: Interventional
• Study Design: Not specified