132 Chapter 6 Data category Information 14. Key inclusion and exclusion criteria Inclusion criteria: • Female • Menstrual migraine • Demonstrated at least 80% compliance with E-diary during baseline period • No or stable for at least two months on prophylactic medication Exclusion criteria: • Smoking • Migraine with aura • Chronic migraine with 15 or more headache days per month/with 8 or more migraine days per month • Medication-overuse headache (ICHD-3 criteria) • Women who are breastfeeding, pregnant, or planning to become pregnant • Oral contraceptive use and not willing to undergo washout period (stop for two consecutive months) • Vitamin E use at start of the study • Use of other sex hormone containing treatments • Increased risk of VTE: history of VTE or thrombophlebitis, hereditary predisposition for VTE (APC resistance, protein C or S deficiency, antithrombin deficiency), VTE in first-degree family member at young age, long term immobilisation • Increased risk of ATE: history of ATE, hereditary predisposition for ATE (hyperhomocysteinemia, antiphospholipid antibodies), ATE in first-degree family member at young age, diabetes mellitus, total cholesterol ≥ 6.5 • Other contraindication for oral contraceptives: liver malignancy, schistosomiasis, HIV/aids, use of immunosuppressives, tuberculosis, sex-hormone-dependent malignancies (breast, endometrial or ovary carcinomas), pancreatitis, vaginal bleeding with unknown cause, other diseases that can influence vessels (malignancies, heart valve disorders, atrial fibrillation, SLE, haemolytic uremic syndrome, chronic inflammatory bowel disease, sickle cell disease) • Contraindication for vitamin E: vitamin K deficiency • Hypersensitivity for any of the compounds in oral contraceptive or vitamin E • Spontaneous postmenopausal status (menstrual bleedings have ceased for 12 consecutive months) • Iatrogenic postmenopausal status • Inability to complete the electronic diary in an accurate manner • Any serious illness that can compromise study participation 15. Study type Interventional Allocation: randomized intervention model. Parallel assignment masking: none (open-label). Primary purpose: prevention Phase III 16. Date of first enrolment June 2019 17. Target sample size 180 18. Recruitment status Recruiting Table 2. continued
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