ACTRN12624000803594Not yet recruitingPhase 4
Profiling the effects of oestrogens, progestogens and allopregnanolone on the brain during neurosteroid withdrawal: toward treating catamenial epilepsy
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- The University of Auckland
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Diagnosis
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (—)
- Sex
- Female
Inclusion Criteria
- •1Participants must be willing and able to give informed consent for participation in the study.
- •2Female (sex presumed female at birth) aged 18-40 years inclusive
- •3BMI 18-35
- •4In the Investigators’ opinion, is able and willing to comply with all study requirements
- •5Must have been stable either on or off neuroactive medications for around 2 months
Exclusion Criteria
- •1Are older than 40, or under 18 years of age
- •2Are currently pregnant, lactating or intending to become pregnant
- •3Current use of any hormonal medication that suppresses the menstrual cycle (hormonal intrauterine implants such as Mirena are acceptable if the person is ovulating)
- •4Have ever undergone gender affirming surgical or recent hormone treatment procedures
- •5Have polycystic ovary syndrome or periods so irregular that they more often than not 1 week longer or shorter than their average
- •6Have premenstrual dysphoric disorder (menstrual cycle related depressive episodes) or menstrual migraine
- •7Have been regularly using any other medication the research team considers may be a problem for the study measures
- •8Any planned changes to neuroactive medication in timeframe of study participation
- •9Inability to speak or read English
- •10Any other condition judged by the study team as likely to impact on the ability of the participant to complete the study
- •11In the overseeing clinicians opinion is contraindicated to receive the intervention
Investigators
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