Trial Review

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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] 313222 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopause 335519 0
Condition category
Condition code
Reproductive Health and Childbirth 332085 332085 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 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] 329795 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] 339674 0
The mean impact of sleep as measured by the PSQI.
Timepoint [1] 339674 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] 440828 0
Level of anxiety
Timepoint [1] 440828 0
Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment
Secondary outcome [2] 440829 0
Level of depression
Timepoint [2] 440829 0
Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment
Secondary outcome [3] 440830 0
Level of interference in life due to hot flashes
Timepoint [3] 440830 0
Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment
Secondary outcome [4] 440831 0
Change in quality of life
Timepoint [4] 440831 0
Baseline (pre-commencement), 1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment
Secondary outcome [5] 440832 0
Change in cognition
Timepoint [5] 440832 0
1 month, 2 months, 3 months, 4 months, 5 months, 6 months post commencement of treatment
Secondary outcome [6] 440833 0
Safety and tolerability of medicinal cannabis This will be assessed as a composite outcome.
Timepoint [6] 440833 0
Baseline (pre-commencement), 3 months & 6 months post commencement of treatment
Secondary outcome [7] 440834 0
Development of cannabis use disorder (CUD)
Timepoint [7] 440834 0
3 months & 6 months post commencement of treatment
Secondary outcome [8] 440835 0
Patient satisfaction with medicinal cannabis
Timepoint [8] 440835 0
3 months & 6 months post commencement of treatment
Secondary outcome [9] 440838 0
Global change
Timepoint [9] 440838 0
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?
No
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
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317664 0
Commercial sector/Industry
Name [1] 317664 0
Cannim Group Pty Ltd
Country [1] 317664 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cannim Group Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319978 0
None
Name [1] 319978 0
Address [1] 319978 0
Country [1] 319978 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316362 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 316362 0
Ethics committee country [1] 316362 0
Australia
Date submitted for ethics approval [1] 316362 0
30/09/2024
Approval date [1] 316362 0
Ethics approval number [1] 316362 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137654 0
Dr Guoyan Yang
Address 137654 0
Western Sydney University Building J, Westmead Campus Locked Bag 1797 Penrith NSW 2751
Country 137654 0
Australia
Phone 137654 0
+61 2 9685 4720
Fax 137654 0
Email 137654 0
[email protected]
Contact person for public queries
Name 137655 0
Guoyan Yang
Address 137655 0
Western Sydney University Building J, Westmead Campus Locked Bag 1797 Penrith NSW 2751
Country 137655 0
Australia
Phone 137655 0
+61 2 9685 4732
Fax 137655 0
Email 137655 0
[email protected]
Contact person for scientific queries
Name 137656 0
Guoyan Yang
Address 137656 0
Western Sydney University Building J, Westmead Campus Locked Bag 1797 Penrith NSW 2751
Country 137656 0
Australia
Phone 137656 0
+61 2 9685 4732
Fax 137656 0
Email 137656 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form  [email protected] Consent Form_30Sep24.docx
OtherParticipant Information Sheet [email protected] 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.