ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12624001363572p

Ethics application status

Submitted, not yet approved

Date submitted

18/10/2024

Date registered

13/11/2024

Date last updated

13/11/2024

Date data sharing statement initially provided

13/11/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

The Lumir Mission Medicinal Cannabis for Menopause Symptoms Study

Scientific title

The Lumir Mission Medicinal Cannabis for Menopause Symptoms Study in women aged between 45-55 years old.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Menopause

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 medicinal 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.

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]

The mean impact of sleep as measured by the PSQI.

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]

Level of anxiety

Timepoint [1]

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

Secondary outcome [2]

Level of depression

Timepoint [2]

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

Secondary outcome [3]

Level of interference in life due to hot flashes

Timepoint [3]

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

Secondary outcome [4]

Change in quality of life

Timepoint [4]

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

Secondary outcome [5]

Change in cognition

Timepoint [5]

1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment

Secondary outcome [6]

Safety and tolerability of medicinal cannabis
This will be assessed as a composite outcome.

Timepoint [6]

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

Secondary outcome [7]

Development of cannabis use disorder (CUD)

Timepoint [7]

3 months & 6 months post commencement of treatment

Secondary outcome [8]

Patient satisfaction with medicinal cannabis

Timepoint [8]

3 months & 6 months post commencement of treatment

Secondary outcome [9]

Global change

Timepoint [9]

3 months & 6 months post commencement of treatment

Eligibility

Key inclusion criteria

1. Women aged between 45 and 55 years who meet criteria for perimenopause or postmenopausal status using the Stages of Reproductive Aging Workshop (STRAW+10) criteria. Perimenopause will include both early menopause transition (variability of 7 or more days in the menstrual cycle within 10 cycles of the first variable length cycle) and late menopause transition (amenorrhea for at least 60 days and increased variability in cycle length).
Post menopause will be defined as 12 consecutive months without menstruation.
2. Women who reach a score of 14 or more on the Menopause Rating Scale (MRS), indicating the need of treatment for climacteric symptoms, are eligible for this study.
3. Results within normal ranges on screening pathology test: full blood exam, liver function tests, urea and electrolytes.
4. Women who are experiencing difficulties with sleep including either falling asleep or staying asleep.

Minimum age

45 Years

Maximum age

55 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Participants will be excluded if they:
1. Have used medical or illicit cannabis within the past 2 months; and are unwilling to complete a 6-wash-out period from cannabis
2. Are enrolled in another active research project using an intervention for menopause symptoms;
3. Have been diagnosed with psychiatric affective and non-affective disorders including dissociative disorder, obsessive-compulsive disorder, personality disorders, schizophrenia, bipolar disorder;
4. Have started, stopped, or made significant changes to dosage of any menopause-related medication (including hormonal, any herbs or supplements) in the past 3 months;
5. Have used any recreational drugs in the preceding 3 months or significant current alcohol use (defined as history of alcohol or substance abuse or dependence within the past 2 years (and across the lifespan for cannabis and cannabis products), as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, or pattern of alcohol use over the last 3 months averaging in excess of 21 standard drinks per week or 4 standard drinks in any given day)
6. Have abnormal results on the screening pathology tests (full blood exam (FBE), liver function test (LFT), urea and electrolytes (U&E)).

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

Not yet recruiting

Date of first participant enrolment

Anticipated

3/02/2025

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

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]

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Cannim Group Pty Ltd

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet 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]

30/09/2024

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This study will determine if there are any changes in sleep difficulties in relation to menopause, and other symptoms of menopause as well as looking at the rate of adverse events after using medicinal cannabis. This study will provide data for future clinical trials if potential benefits are found. 
We hypothesise that medicinal cannabis can improve sleep quality in relation to menopause, alongside other symptoms.

Trial website

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

Dr Guoyan Yang

Address

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

Country

Australia

Phone

+61 2 9685 4720

Fax

e.yang@westernsydney.edu.au

Contact person for public queries

Name

Guoyan Yang

Address

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

Country

Australia

Phone

+61 2 9685 4732

Fax

e.yang@westernsydney.edu.au

Contact person for scientific queries

Name

Guoyan Yang

Address

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

Country

Australia

Phone

+61 2 9685 4732

Fax

e.yang@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	Link	Email	Other Details	Attachment
24286	Informed consent form			menocann@westernsydney.edu.au		388649-(Uploaded-18-10-2024-13-54-52)-Consent Form_30Sep24.docx
24287	Other	Participant Information Sheet		menocann@westernsydney.edu.au		388649-(Uploaded-18-10-2024-13-54-52)-PIS_27 Sept_Final.docx

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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