Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000681459p
Ethics application status
Submitted, not yet approved
Date submitted
6/06/2025
Date registered
27/06/2025
Date last updated
27/06/2025
Date data sharing statement initially provided
27/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
SLUMBER: A Study on the impact of Late-night Use of Melatonin in the Burden of Endometriosis-Related Sleep Disturbance
Scientific title
SLUMBER: A Study on the impact of Late-night Use of Melatonin in the Burden of Endometriosis-Related Sleep Disturbance
Secondary ID [1] 314456 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SLUMBER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endometriosis 337492 0
Condition category
Condition code
Reproductive Health and Childbirth 333858 333858 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This clinical study is investigating the effects of slow-release melatonin on sleep disturbance in individuals with endometriosis. Participants are assigned to one of two groups receiving either 10mg or 20mg of slow-release melatonin, supplied from a compounding pharmacy and taken as an oral tablet one hour before bed for a period of eight weeks. To help monitor adherence, participants complete a brief weekly diary documenting their nightly use of the study medication. By comparing the two dosage arms, the study aims to evaluate both the safety and potential benefits of melatonin in managing endometriosis-related sleep disturbance.
Intervention code [1] 331078 0
Treatment: Drugs
Comparator / control treatment
Microcellulose capsule/tablet
Control group
Placebo

Outcomes
Primary outcome [1] 341479 0
To evaluate the effect of 10 mg slow-release melatonin, compared to placebo, on sleep quality as measured by changes in Pittsburgh Sleep Quality Index scores from baseline to 8 weeks in individuals with endometriosis.
Timepoint [1] 341479 0
8 weeks after commencement of treatment
Secondary outcome [1] 447715 0
Identify if melatonin use is associated with a change in radiological lesion size.
Timepoint [1] 447715 0
Within 12 weeks post completion of treatment
Secondary outcome [2] 447709 0
Determine whether melatonin use has a statistically significant change in pain scores in patients with endometriosis compared to placebo after 8 weeks
Timepoint [2] 447709 0
8 weeks post commencement of treatment
Secondary outcome [3] 447710 0
To compare the effects of 20 mg versus 10 mg slow-release melatonin on sleep-related symptoms in individuals with endometriosis.
Timepoint [3] 447710 0
8 weeks post commencement of treatment
Secondary outcome [4] 447712 0
Identify any short-term adverse events or side effects of melatonin use after 8 weeks in patients with endometriosis using 10mg or 20mg daily melatonin for 8 weeks compared to placebo.
Timepoint [4] 447712 0
8 weeks post commencement of treatment
Secondary outcome [5] 447711 0
Evaluate whether melatonin use, either 10mg and/or 20mg, is associated with a change in other endometriosis symptoms in addition to sleep compared to placebo.
Timepoint [5] 447711 0
8 weeks post commencement of treatment
Secondary outcome [6] 448754 0
To compare the effects of 20 mg versus 10 mg slow-release melatonin on pain symptoms in individuals with endometriosis.
Timepoint [6] 448754 0
8 weeks post commencement of treatment

Eligibility
Key inclusion criteria
• Current patient of a Julia Argyrou Endometriosis Centre at Epworth or Epworth gynaecology VMO
• Greater than or equal to 18 years of age, pre-menopausal
• Able to consent
• Have a prior surgical/radiological diagnosis of endometriosis and are currently experiencing endometriosis-related symptoms
• Be living in Australia
• Access to internet
• English speaking
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have a diagnosed sleep disorder
• Patient plans to have surgery or to commence new therapy for endometriosis during the 8 week trial period
• Have a known liver condition that requires specialist input or is associated with LFT derangement
• Have an allergy to melatonin
• Pregnant or breastfeeding or planning to conceive in the study period
• Taking any other medications for sleep

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes. Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Yes. Permuted block randomisation.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
1/01/2026
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
171
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318994 0
Hospital
Name [1] 318994 0
Epworth Healthcare
Country [1] 318994 0
Australia
Primary sponsor type
Hospital
Name
Epworth Healthcare
Address
Country
Australia
Secondary sponsor category [1] 321459 0
None
Name [1] 321459 0
Address [1] 321459 0
Country [1] 321459 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317607 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 317607 0
Ethics committee country [1] 317607 0
Australia
Date submitted for ethics approval [1] 317607 0
15/04/2025
Approval date [1] 317607 0
Ethics approval number [1] 317607 0

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

Contacts
Principal investigator
Name 141542 0
Dr Kate Tyson
Address 141542 0
Julia Argyrou Endometriosis Centre at Epworth. Ground Floor 185-187 Hoddle Street Richmond VIC 3121
Country 141542 0
Australia
Phone 141542 0
+61 03 9516 2434
Fax 141542 0
Email 141542 0
[email protected]
Contact person for public queries
Name 141543 0
Kate Tyson
Address 141543 0
Julia Argyrou Endometriosis Centre at Epworth. Ground Floor 185-187 Hoddle Street Richmond VIC 3121
Country 141543 0
Australia
Phone 141543 0
+61 03 9516 2434
Fax 141543 0
Email 141543 0
[email protected]
Contact person for scientific queries
Name 141544 0
Kate Tyson
Address 141544 0
Julia Argyrou Endometriosis Centre at Epworth. Ground Floor 185-187 Hoddle Street Richmond VIC 3121
Country 141544 0
Australia
Phone 141544 0
+61 03 9516 2434
Fax 141544 0
Email 141544 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided


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.