Endometriosis Urological and Genital Diseases
Conditions
Interventions
Participants will be randomised into one of two treatment arms, via an online randomisation tool.
CBD arm: participants in the active arm will be given oral CBD solution for 12 weeks duration. The sta
Sponsors
University of Edinburgh and NHS Lothian
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Women or assigned female at birth 2. Aged 18 years or over 3. Endometriosis identified at laparoscopy or imaging, performed within the last ten years 4. Self reported pelvic pain for more than six months 5. Weekly worst pain score of at least four on a numerical rating scale (NRS) on two or more occasions over the four weeks prior to randomisation 6. Willing not to take additional cannabinoids during the trial period 7. Willing to use effective contraception throughout the trial (if needed) 8. Willing and able to give informed consent 9. Willing to be contacted by text message
Exclusion criteria
Exclusion criteria: 1. Pregnant, breastfeeding or actively trying to get pregnant 2. Post-menopausal (no periods for >12 months and not taking hormonal treatments to prevent periods, or bilateral oophorectomy performed) 3. Suicidal thoughts or severe depression within the past year 4. Current use (or within the last 1 month) of other cannabinoid or cannabis products, determined by urine dipstick test 5. Chronic alcohol abuse 6. History of severe liver disease (Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) more than 3-times the upper limit of normal (ULN)) and bilirubin greater than 2 times the ULN, Or moderate to severe hepatic impairment (Child-Pugh class B or C) 7. Concomitant use of Sodium Valproate, Clobazam, Stiripentol, Everolimus 8. Hypersensitivity to any of the components of the formulation as defined in the IB 9. Taking part in another CTIMP or interventional non-CTIMP study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of those eligible who are consented and recruited (screening logs) from first screening, the proportion who are eligible and randomised after the screening period and those randomised who are retained (completing the 12 week outcome measures) after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at weeks 1-13: 1. Pain (NRS worst and average pain score, Pain DETECT, pain domain of EHP-30) 2. Quality of life (EHP30, Fatigue Severity Scale (FSS), Fibromyalgia scale, The Sleep Timing Questionnaire (STQ), Pain Catastrophising Questionnaire (PCQ), Gastrointestinal Symptom Rating Scale (GSRS), Patient Global Impression of Change (PGIC) questionnaires) 3. Safety (side effects, adverse events, full blood count and clinical chemistry, patient health questionnaire (PHQ-9)) 4. Analgesic use (participant-reported) 5. Compliance with medication (dose escalation, self-reported and volume returned) 6. Acceptability of trial and patient satisfaction (assessed by questionnaire and optional qualitative interview at the end of study) 7. Health economic (EQ-5D-5L, medication use, healthcare (resource) visits) 8. Measure inflammatory markers in serum and plasma samples Tertiary outcome: Comparison of movement, ambient temperature and light (which indicates activity and sleep) collected with a smartwatch, with responses captured in the FFS and STQ questionnaires | — |
Countries
Scotland, United Kingdom
Contacts
Public Contact- ENDOCAN-1 Trial Team
Outcome results
None listed