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Trial registered on ANZCTR
Registration number
ACTRN12624000803594
Ethics application status
Approved
Date submitted
24/05/2024
Date registered
28/06/2024
Date last updated
28/06/2024
Date data sharing statement initially provided
28/06/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Profiling how female sex steroids affect the brain perimenstrually
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Scientific title
Profiling the effects of oestrogens, progestogens and allopregnanolone on the brain during neurosteroid withdrawal: toward treating catamenial epilepsy
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Secondary ID [1]
312215
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None
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Universal Trial Number (UTN)
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Trial acronym
P2TCAT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Catamenial epilepsy
333893
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Condition category
Condition code
Neurological
330574
330574
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0
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Epilepsy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Depending on their cohort, participants will take either:
17ß-estradiol 2mg tablet (sublingually) twice OR
Progesterone 200mg capsule (orally) twice OR
Levonorgestreal 1.5mg (orally) twice
Each dose will be taken during one mid-follicular phase of the menstrual cycle and one perimenstrual phase, no less than one week apart. Doses will be taken in the lab, observed by a researcher.
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Intervention code [1]
328661
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Diagnosis / Prognosis
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Intervention code [2]
328708
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Treatment: Drugs
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Comparator / control treatment
17ß-estradiol
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Control group
Active
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Outcomes
Primary outcome [1]
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Electroencephalography
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Assessment method [1]
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Electroencephalography evoked potential changes
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Timepoint [1]
338326
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Approximately 1 hour post intervention
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Primary outcome [2]
338384
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Electroencephalography
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Assessment method [2]
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Electroencephalography oscillation changes
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Timepoint [2]
338384
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Approximately 1 hour post-intervention
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Secondary outcome [1]
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Blood
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Assessment method [1]
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Concentrations of hormones in plasma
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Timepoint [1]
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Approximately 1 hour post intervention
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Secondary outcome [2]
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Visual psychophysics
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Assessment method [2]
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Performance on a task (based on correct/incorrect key press)
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Timepoint [2]
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Approximately 1 hour post intervention
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Eligibility
Key inclusion criteria
1 Participants must be willing and able to give informed consent for participation in the study.
2 Female (sex presumed female at birth) aged 18-40 years inclusive
3 BMI 18-35
4 In the Investigators’ opinion, is able and willing to comply with all study requirements
5 Must have been stable either on or off neuroactive medications for around 2 months
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1 Are older than 40, or under 18 years of age
2 Are currently pregnant, lactating or intending to become pregnant
3 Current use of any hormonal medication that suppresses the menstrual cycle (hormonal intrauterine implants such as Mirena are acceptable if the person is ovulating)
4 Have ever undergone gender affirming surgical or recent hormone treatment procedures
5 Have polycystic ovary syndrome or periods so irregular that they more often than not 1 week longer or shorter than their average
6 Have premenstrual dysphoric disorder (menstrual cycle related depressive episodes) or menstrual migraine
7 Have been regularly using any other medication the research team considers may be a problem for the study measures
8 Any planned changes to neuroactive medication in timeframe of study participation
9 Inability to speak or read English
10 Any other condition judged by the study team as likely to impact on the ability of the participant to complete the study
11 In the overseeing clinicians opinion is contraindicated to receive the intervention
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
10/07/2024
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Actual
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Date of last participant enrolment
Anticipated
31/12/2025
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Actual
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Date of last data collection
Anticipated
31/03/2026
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26335
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New Zealand
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State/province [1]
26335
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Funding & Sponsors
Funding source category [1]
316589
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Charities/Societies/Foundations
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Name [1]
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Auckland Medical Research Foundation
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Address [1]
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Country [1]
316589
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New Zealand
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Funding source category [2]
316590
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Government body
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Name [2]
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Health Research Council of New Zealand
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Address [2]
316590
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Country [2]
316590
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New Zealand
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Primary sponsor type
University
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Name
The University of Auckland
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
318771
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Address [1]
318771
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Country [1]
318771
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315376
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Southern Health and Disability Ethics Committee
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Ethics committee address [1]
315376
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https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
315376
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18/04/2024
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Approval date [1]
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29/04/2024
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Ethics approval number [1]
315376
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2024 EXP 19349
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Summary
Brief summary
For 40% of women with epilepsy, their menstrual cycle will worsen their seizures. They will experience at least twice as many seizures as they ordinarily would, and the seizures may be more severe than usual. The perimenstrual phase is when the brain is thought to change how sensitive it is to hormones. Catamenial seizures are more common in this phase. We will give females without epilepsy doses of synthetic hormones and use electroencephalography, blood sampling and visual psychophysics to study which hormones the brain is more/less sensitive to in the perimenstrual phase and how this may be affecting major neurochecmical systems in the brain.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Rachael Sumner
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Address
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School of Pharmacy, The University of Auckland, Private Bag 92019 Auckland 1142 New Zealand
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Country
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New Zealand
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Phone
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+64 0272832935
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Rachael Sumner
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Address
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School of Pharmacy, The University of Auckland, Private Bag 92019 Auckland 1142 New Zealand
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Country
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New Zealand
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Phone
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+64 0272832935
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Rachael Sumner
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Address
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School of Pharmacy, The University of Auckland, Private Bag 92019 Auckland 1142 New Zealand
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Country
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New Zealand
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Phone
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+64 0272832935
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Fax
134512
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Email
134512
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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