None listed
Conditions
Brief summary
This study will determine if there are any changes in period pain, and other symptoms of primary dysmenorrhea as well as looking at the rate of adverse events after using medicinal cannabis. Changes in inflammatory markers in menstrual blood will also be tracked. This study will provide data for future clinical trials if potential benefits are found.
Interventions
Participants will be prescribed a type of medicinal cannabis (MC) as part of their participation in this study by a medicinal cannabis doctor via a telehealth appointment at the Natura Clinic. The medical doctor will assess if the participant is suitable for medicinal cannabis and will use the same criteria as for members of the general public wishing to use medicinal cannabis to manage period pain. The research team has no involvement in the allocation or dispensing of medicinal cannabis produ
Participants will be prescribed a type of medicinal cannabis (MC) as part of their participation in this study by a medicinal cannabis doctor via a telehealth appointment at the Natura Clinic. The medical doctor will assess if the participant is suitable for medicinal cannabis and will use the same criteria as for members of the general public wishing to use medicinal cannabis to manage period pain. The research team has no involvement in the allocation or dispensing of medicinal cannabis products and the decision to prescribe medcinal cannabis for the potential participant rests solely with the medical doctor. A specific type of MC, dose range and mode of administration will be individualised to each patient. MC products will be chosen by the MC doctor using the project formulary which includes cannabidiol (CBD) only products, delta-9-tetrahydrocannabinol (THC) dominant products and mixed CBD/THC products. The MC doctor will prescribe MC products based on pain experienced by the participant. Modes of administration include: flower products, vape (cartridge) and oils. The dose range and mode of administration will be prescribed by the MC doctor at the participant's baseline visit at the medicinal cannabis clinic. Over the course of the observation period the doctor can change dosage or product if required due to adverse events or lack of efficacy. Participants will use MC products for 6 months. Blood tests: Participants are to attend a Laverty Pathology (or sister site) collection centre for: full blood exam, liver function tests and kidney function tests including urea and electrolytes and hsCRP. These will be done at baseline, 3 months and 6 months. Menstrual blood testing: Menstrual blood will be tested in 10 participants using a convenience sample. Due to the need to be able to deliver this sample to NICM @ Westmead, only those study participants who are living in Sydney, NSW will be asked if they wish to participate in this phase. Menstrual blood will be collected during the first 48 hours of menstruation at baseline, 3 months and 6 months. Each month, participants will be required to complete a series of questionnaires. Monitoring: Side effects will be tracked during study via monthly reporting by participants through REDCap. Participants will be advised to contact their treating medicinal cannabis doctor at Natura Clinic if they experience any serious side effects/adverse events. The modified COMM survey will be used to assess the participant for cannabis use disorder.
Sponsors
Western Sydney University
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Female with primary dysmenorrhoea characterised by: o Age of onset of menstrual pain within 3 years of menarche. o Recurrent, crampy, suprapubic pain occurring just before or during menses and usually most severe in the first 72 hours from onset of menstrual bleeding. o Pelvic pain that does not regularly occur outside of menses. o Pain that shows some improvement with NSAIDs and/or contraceptive pill. o No history of regular dyspareunia, dysuria, or dyschezia • Aged 20 years or over • Has not used cannabis within the last 3 months • Willing to use contraception for the duration of the study • Able to travel to a Laverty Pathology (or sister site) collection centre for three blood tests • Full blood exam, liver and kidney function (including urea and electrolytes) safety markers within normal ranges. • Able to complete online study questionnaires • Willing to give informed consent to participate in the Study • Able to understand and comprehend English
Exclusion criteria
• Has used cannabis in the past 3 months • Pelvic pain or menstrual pain due to secondary dysmenorrhoea (e.g., endometriosis) • Pregnant or planning to become pregnant during the study duration • Unwilling to use contraception for the duration of the study • Unable to travel to a Laverty Pathology (or sister site) collection centre for three blood tests • Full blood exam, liver and kidney function (including urea and electrolytes) safety markers not within normal ranges. • Current medical condition which in the opinion of the Study Coordinator or medicinal cannabis doctor (Natura Clinic) is a contraindication for medicinal cannabis • Unwilling to complete study assessments using REDCap questionnaires • Unwilling or unable to provide informed consent to participate in the study • Unable to understand and comprehend English
Outcome results
None listed