None listed
Conditions
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.
Interventions
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.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed