ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

primary dysmenorrhea

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

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]

Baseline (pre-commencement), 1 month, 2 months, 3 months (primary timepoint, 4 months, 5 months, 6 months post commencement of treatment

Secondary outcome [1]

1. Menstrual pain as measured by the revised Short Form-McGill Pain Questionnaire (SF-MPQ)

Timepoint [1]

Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment

Secondary outcome [2]

2. Pre-menstrual symptoms as measured by the Premenstrual Symptoms Screening Test (PSST)

Timepoint [2]

Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment

Secondary outcome [3]

3. Duration of menstrual pain as measured by the menstrual pain diary (MPD)

Timepoint [3]

Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment

Secondary outcome [4]

4. Quality of life as measured by the EQ-5D quality of life questionnaire score

Timepoint [4]

Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment

Secondary outcome [5]

5. Systemic inflammation as measured by levels of serum high sensitivity C-reactive protein (hs-CRP)

Timepoint [5]

Baseline (pre-commencement), 3 months, 6 months post commencement of treatment

Secondary outcome [6]

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]

Baseline (pre-commencement), 3 months, 6 months post commencement of treatment

Secondary outcome [7]

7. Menstrual flow via a pictorial blood loss assessment chart (PBAC)

Timepoint [7]

Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment

Secondary outcome [8]

8. Absenteeism/presenteeism (Absenteeism and presenteeism will be measured together)

Timepoint [8]

Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment

Secondary outcome [9]

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]

Baseline (pre-commencement), 3 months, 6 months post commencement of treatment

Secondary outcome [10]

10. Development of cannabis use disorder (CUD) as measured by the Modified current opioid misuse measure (COMM)

Timepoint [10]

At 6 months post commencement of treatment

Secondary outcome [11]

11. Patient satisfaction with the intervention, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)

Timepoint [11]

At 6 months post commencement of treatment

Secondary outcome [12]

12. Global change as measured by the Patient Global Impression of Change (PGIC) questionnaire

Timepoint [12]

At 6 months post commencement of treatment

Secondary outcome [13]

13. Recording of rescue analgesic medication in MPD

Timepoint [13]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Cannim Group Pty Ltd

Address [1]

Suite 406/39 East Esplanade Manly NSW 2095

Country [1]

Australia

Funding source category [2]

University

Name [2]

Western Sydney University

Address [2]

Country [2]

Australia

Primary sponsor type

University

Name

Western Sydney University

Address

Suite 406/39 East Esplanade Manly NSW 2095

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Western Sydney Human Research Ethics Committee

Ethics committee address [1]

https://www.westernsydney.edu.au/research/research_ethics_and_integrity/human_ethics/apply_for_human_research_ethics_review

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/11/2023

Approval date [1]

13/02/2024

Ethics approval number [1]

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

A/Prof Mike Armour

Address

Western Sydney University Building J, Westmead Campus Locked Bag 1797 Penrith NSW 2751

Country

Australia

Phone

+61 2 9685 4720

Fax

m.armour@westernsydney.edu.au

Contact person for public queries

Name

Mike Armour

Address

Western Sydney University Building J, Westmead Campus Locked Bag 1797 Penrith NSW 2751

Country

Australia

Phone

+61 2 9685 4720

Fax

m.armour@westernsydney.edu.au

Contact person for scientific queries

Name

Mike Armour

Address

Western Sydney University Building J, Westmead Campus Locked Bag 1797 Penrith NSW 2751

Country

Australia

Phone

+61 2 9685 4720

Fax

m.armour@westernsydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Email	Other Details	Attachment
21073	Informed consent form		canndyshelp@westernsydney.edu.au		386955-(Uploaded-04-03-2024-16-17-41)-Study-related document.doc
21074	Other	Participant Information Sheet	canndyshelp@westernsydney.edu.au	Participant information sheet	386955-(Uploaded-04-03-2024-16-17-50)-Study-related document.doc
21798	Ethical 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.

Trial Review

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