A placebo controlled, double blind, randomised controlled trial assessing the effect of medicinal cannabis on pelvic pain in adults with endometriosis: The Endocann trial

Western Sydney University0 个研究点目标入组 126 人开始时间: 2024年3月25日最近更新: 2024年9月2日

适应症

试验速览

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•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.

•- 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.

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