Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000644460p
Ethics application status
Submitted, not yet approved
Date submitted
29/05/2025
Date registered
18/06/2025
Date last updated
18/06/2025
Date data sharing statement initially provided
18/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of Zoely for menstrually-related migraine
Scientific title
The safety, tolerability and efficacy of Zoely (nomegestrol acetate/estradiol) for participants diagnosed with menstrually-related migraine
Secondary ID [1] 314555 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menstrually-related migraine 337657 0
Condition category
Condition code
Neurological 333990 333990 0 0
Other neurological disorders
Reproductive Health and Childbirth 333991 333991 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Zoely oral contraceptive pill (estradiol 2.5mg/ nomegestrol acetate 1.5mg) daily for 12 weeks. Adherence will be monitored through monthly telephone calls by investigators to each participant.
Intervention code [1] 331182 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341653 0
Composite primary outcome of safety and tolerability
Timepoint [1] 341653 0
Baseline and 12 weeks after intervention
Primary outcome [2] 341654 0
Adverse events
Timepoint [2] 341654 0
Follow up will occur each month of the intervention (baseline, month 1, month 2, month 3, project closure). The baseline visit is required to be face-to-face but subsequent follow up can occur via telephone review per patient preference
Secondary outcome [1] 448208 0
Change to monthly headache days from baseline
Timepoint [1] 448208 0
Baseline and 12 weeks after intervention
Secondary outcome [2] 448211 0
Change to number of days of acute analgesic use
Timepoint [2] 448211 0
Baseline and 12 weeks after intervention
Secondary outcome [3] 448212 0
Quality of life
Timepoint [3] 448212 0
Baseline and end of 12 weeks intervention
Secondary outcome [4] 448654 0
Change to monthly migraine days from baseline
Timepoint [4] 448654 0
Baseline and 12 weeks after intervention

Eligibility
Key inclusion criteria
Aged 18-40 years at time of enrolment, current diagnosis of MRM without aura (ICHD-3 criteria), no change in migraine treatment in the preceding 3 months prior to enrolment and for the duration of the study, and no contraindications to hormonal therapy.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged over 40 years, migraine with aura, history of ischemic cerebral infarct/ stroke, history of thrombosis or blood clots, known disorder affecting blood clotting, history of breast, uterine or ovarian cancer, undiagnosed vaginal bleeding, liver disease, opioid medication overuse, pregnancy or plans to become pregnant during study period, or currently breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
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
31/07/2027
Actual
Date of last data collection
Anticipated
31/10/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27981 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 44177 0
3004 - St Kilda Road Melbourne
Recruitment postcode(s) [2] 44178 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 319105 0
Hospital
Name [1] 319105 0
The Alfred
Country [1] 319105 0
Australia
Funding source category [2] 319110 0
University
Name [2] 319110 0
Monash University
Country [2] 319110 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 321574 0
None
Name [1] 321574 0
Address [1] 321574 0
Country [1] 321574 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317702 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317702 0
Ethics committee country [1] 317702 0
Australia
Date submitted for ethics approval [1] 317702 0
04/06/2025
Approval date [1] 317702 0
Ethics approval number [1] 317702 0

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

Contacts
Principal investigator
Name 141862 0
Prof Jayashri Kulkarni
Address 141862 0
Multidisciplinary Alfred Psychiatry Research Centre (MAPrc), 607 Saint Kilda Rd, Melbourne, VIC 3004
Country 141862 0
Australia
Phone 141862 0
+6139076 8156
Fax 141862 0
Email 141862 0
[email protected]
Contact person for public queries
Name 141863 0
Dr Lakshini Gunasekera
Address 141863 0
Alfred Hospital, 55 Commercial Rd, Melbourne, VIC 3004
Country 141863 0
Australia
Phone 141863 0
+6139076 2000
Fax 141863 0
Email 141863 0
[email protected]
Contact person for scientific queries
Name 141864 0
Dr Lakshini Gunasekera
Address 141864 0
Alfred Hospital, 55 Commercial Rd, Melbourne, VIC 3004
Country 141864 0
Australia
Phone 141864 0
+6139076 2000
Fax 141864 0
Email 141864 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.