Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000256572
Ethics application status
Approved
Date submitted
28/11/2023
Date registered
15/03/2024
Date last updated
14/05/2024
Date data sharing statement initially provided
15/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Lumir Mission Medicinal Cannabis for Primary Dysmenorrhoea Study
Scientific title
The Lumir Mission Medicinal Cannabis for Primary Dysmenorrhoea Study in Women 20 years or older
Secondary ID [1] 311052 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
primary dysmenorrhea 332171 0
Condition category
Condition code
Reproductive Health and Childbirth 328888 328888 0 0
Menstruation and menopause

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 327496 0
Not applicable
Comparator / control treatment
No control group
Doses, duration of administration, mode of administration, etc for the specified groups are not included as they will be individualised to the participants.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336698 0
Severity of menstrual pain, as measured by mean change in peak menstrual pain on a 0-10 numerical rating scale over the first 3 days of menses (recorded in a menstrual pain diary).
Timepoint [1] 336698 0
Baseline (pre-commencement), 1 month, 2 months, 3 months (primary timepoint, 4 months, 5 months, 6 months post commencement of treatment
Secondary outcome [1] 429351 0
1. Menstrual pain as measured by the revised Short Form-McGill Pain Questionnaire (SF-MPQ)
Timepoint [1] 429351 0
Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment
Secondary outcome [2] 429352 0
2. Pre-menstrual symptoms as measured by the Premenstrual Symptoms Screening Test (PSST)
Timepoint [2] 429352 0
Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment
Secondary outcome [3] 429353 0
3. Duration of menstrual pain as measured by the menstrual pain diary (MPD)
Timepoint [3] 429353 0
Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment
Secondary outcome [4] 429354 0
4. Quality of life as measured by the EQ-5D quality of life questionnaire score
Timepoint [4] 429354 0
Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment
Secondary outcome [5] 429355 0
5. Systemic inflammation as measured by levels of serum high sensitivity C-reactive protein (hs-CRP)
Timepoint [5] 429355 0
Baseline (pre-commencement), 3 months, 6 months post commencement of treatment
Secondary outcome [6] 429356 0
6. Level of inflammation as measured by levels of prostaglandins (PGF2a), interleukin-6 (IL-6) and tumour necrosis factor (TNFa) in the menstrual blood
Timepoint [6] 429356 0
Baseline (pre-commencement), 3 months, 6 months post commencement of treatment
Secondary outcome [7] 429357 0
7. Menstrual flow via a pictorial blood loss assessment chart (PBAC)
Timepoint [7] 429357 0
Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment
Secondary outcome [8] 429358 0
8. Absenteeism/presenteeism (Absenteeism and presenteeism will be measured together)
Timepoint [8] 429358 0
Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment
Secondary outcome [9] 429359 0
9. Safety and tolerability of MC, as measured by frequency and types of side effects and changes in blood markers including liver function tests and kidney function tests (urea and electrolytes)
Safety and tolerability will be assessed as a composite secondary outcome.
Timepoint [9] 429359 0
Baseline (pre-commencement), 3 months, 6 months post commencement of treatment
Secondary outcome [10] 429360 0
10. Development of cannabis use disorder (CUD) as measured by the Modified current opioid misuse measure (COMM)
Timepoint [10] 429360 0
At 6 months post commencement of treatment
Secondary outcome [11] 429361 0
11. Patient satisfaction with the intervention, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
Timepoint [11] 429361 0
At 6 months post commencement of treatment
Secondary outcome [12] 429362 0
12. Global change as measured by the Patient Global Impression of Change (PGIC) questionnaire
Timepoint [12] 429362 0
At 6 months post commencement of treatment
Secondary outcome [13] 429363 0
13. Recording of rescue analgesic medication in MPD
Timepoint [13] 429363 0
Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment

Eligibility
Key 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
Minimum age
20 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
A range of statistical methods will be used, including within-groups analyses to assess changes in outcome variables, comparing mean outcomes of rating scales or questionnaire scores with baseline, at 3 and 6 months.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
10/04/2024
Date of last participant enrolment
Anticipated
2/09/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
65
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315309 0
Commercial sector/Industry
Name [1] 315309 0
Cannim Group Pty Ltd
Country [1] 315309 0
Australia
Funding source category [2] 315992 0
University
Name [2] 315992 0
Western Sydney University
Country [2] 315992 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Suite 406/39 East Esplanade Manly NSW 2095
Country
Australia
Secondary sponsor category [1] 317360 0
None
Name [1] 317360 0
Address [1] 317360 0
Country [1] 317360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314232 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 314232 0
https://www.westernsydney.edu.au/research/research_ethics_and_integrity/human_ethics/apply_for_human_research_ethics_review
Ethics committee country [1] 314232 0
Australia
Date submitted for ethics approval [1] 314232 0
23/11/2023
Approval date [1] 314232 0
13/02/2024
Ethics approval number [1] 314232 0
H15819

Summary
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.
Trial website
https://www.westernsydney.edu.au/nicm/research/clinical_trials/canndyshelp
Trial related presentations / publications
Public notes
The Chief Investigator and Associate Investigators will be responsible for write-up of publications resulting from study data. Proposed publications must not contain any information that is confidential (such as participants’ names or other personal data), other than study results. Data will be collated for analysis to address the primary and secondary objectives of the study. Such data is de-identified. However, in some cases, permission may be sought from individuals to write up their case as a formal case study for publication in a medical journal or presentation at a conference. In such cases, as is required by medical journals, written permission will be gained from the patient and their name or other identifying information will not be associated with the case study. All due care will be taken to minimise any information that could conceivably identify the patient.

Contacts
Principal investigator
Name 130878 0
A/Prof Mike Armour
Address 130878 0
Western Sydney University Building J, Westmead Campus Locked Bag 1797 Penrith NSW 2751
Country 130878 0
Australia
Phone 130878 0
+61 2 9685 4720
Fax 130878 0
Email 130878 0
m.armour@westernsydney.edu.au
Contact person for public queries
Name 130879 0
A/Prof Mike Armour
Address 130879 0
Western Sydney University Building J, Westmead Campus Locked Bag 1797 Penrith NSW 2751
Country 130879 0
Australia
Phone 130879 0
+61 2 9685 4720
Fax 130879 0
Email 130879 0
m.armour@westernsydney.edu.au
Contact person for scientific queries
Name 130880 0
A/Prof Mike Armour
Address 130880 0
Western Sydney University Building J, Westmead Campus Locked Bag 1797 Penrith NSW 2751
Country 130880 0
Australia
Phone 130880 0
+61 2 9685 4720
Fax 130880 0
Email 130880 0
m.armour@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21073Informed consent form  canndyshelp@westernsydney.edu.au 386955-(Uploaded-04-03-2024-16-17-41)-Study-related document.doc
21074OtherParticipant Information Sheet canndyshelp@westernsydney.edu.au Participant information sheet 386955-(Uploaded-04-03-2024-16-17-50)-Study-related document.doc
21798Ethical approval    386955-(Uploaded-13-03-2024-12-48-56)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.