None listed
Conditions
Brief summary
Migraine is a significant problem that predominantly affects young women. Hormonal changes associated with menstruation can be a trigger for migraine flares. We are investigating the use of a combined estrogen/progesterone contraceptive pill to see whether it is safe, well-tolerated and effective in treating the symptoms of menstrually-related migraine.
Interventions
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.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed