Trial Review

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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
Scientific title
Profiling the effects of oestrogens, progestogens and allopregnanolone on the brain during neurosteroid withdrawal: toward treating catamenial epilepsy
Secondary ID [1] 312215 0
None
Universal Trial Number (UTN)
Trial acronym
P2TCAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Catamenial epilepsy 333893 0
Condition category
Condition code
Neurological 330574 330574 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328661 0
Diagnosis / Prognosis
Intervention code [2] 328708 0
Treatment: Drugs
Comparator / control treatment
17ß-estradiol
Control group
Active

Outcomes
Primary outcome [1] 338326 0
Electroencephalography
Timepoint [1] 338326 0
Approximately 1 hour post intervention
Primary outcome [2] 338384 0
Electroencephalography
Timepoint [2] 338384 0
Approximately 1 hour post-intervention
Secondary outcome [1] 435435 0
Blood
Timepoint [1] 435435 0
Approximately 1 hour post intervention
Secondary outcome [2] 435436 0
Visual psychophysics
Timepoint [2] 435436 0
Approximately 1 hour post intervention

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
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 26335 0
New Zealand
State/province [1] 26335 0

Funding & Sponsors
Funding source category [1] 316589 0
Charities/Societies/Foundations
Name [1] 316589 0
Auckland Medical Research Foundation
Country [1] 316589 0
New Zealand
Funding source category [2] 316590 0
Government body
Name [2] 316590 0
Health Research Council of New Zealand
Country [2] 316590 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 318771 0
None
Name [1] 318771 0
Address [1] 318771 0
Country [1] 318771 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315376 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 315376 0
Ethics committee country [1] 315376 0
New Zealand
Date submitted for ethics approval [1] 315376 0
18/04/2024
Approval date [1] 315376 0
29/04/2024
Ethics approval number [1] 315376 0
2024 EXP 19349

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

Contacts
Principal investigator
Name 134510 0
Dr Rachael Sumner
Address 134510 0
School of Pharmacy, The University of Auckland, Private Bag 92019 Auckland 1142 New Zealand
Country 134510 0
New Zealand
Phone 134510 0
+64 0272832935
Fax 134510 0
Email 134510 0
r.sumner@auckland.ac.nz
Contact person for public queries
Name 134511 0
Rachael Sumner
Address 134511 0
School of Pharmacy, The University of Auckland, Private Bag 92019 Auckland 1142 New Zealand
Country 134511 0
New Zealand
Phone 134511 0
+64 0272832935
Fax 134511 0
Email 134511 0
r.sumner@auckland.ac.nz
Contact person for scientific queries
Name 134512 0
Rachael Sumner
Address 134512 0
School of Pharmacy, The University of Auckland, Private Bag 92019 Auckland 1142 New Zealand
Country 134512 0
New Zealand
Phone 134512 0
+64 0272832935
Fax 134512 0
Email 134512 0
r.sumner@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.