131 Rationale and protocol of the WHAT! Trial 6 Table 2. Trial registration data. Data category Information 1. Primary registry and trial identifying number ClinicalTrials.gov NCT04007874 2. Date of registration in primary registry 28 June, 2019 3. Secondary identifying numbers 2018-004096-12 (EudraCT) 4, Source(s) of monetary or material support Netherlands Organization for Health Research (849200007) and the Dutch Brain Foundation (HA2017.01.05) 5. Primary sponsor Leiden University Medical Center, Leiden, The Netherlands 6. Secondary sponsor(s) Erasmus Medical Center, Rotterdam, The Netherlands 7. Contact for public queries B.W.H.van_der_Arend@lumc.nl 8. Contact for scientific queries B.W.H.van_der_Arend@lumc.nl 9. Public title Oral Contraceptive Pill Compared With Vitamin E in Women With Migraine (WHATT) 10. Scientific title Open-label Randomized Controlled Trial for the Effects of Continuous Ethinylestradiol/Levonorgestrel (30/150 μg/Day) Compared With Vitamin E (400 IU/Day) in the Treatment of Menstrually-related Migraine 11. Countries of recruitment Netherlands 12. Health condition(s) or problem(s) studied • Migraine • Migraine; Menstrual 13. Intervention(s) Active comparator: Ethinylestradiol/levonorgestrel • Ethinylestradiol/levonorgestrel 30/150 µg oral tablets once daily without a stopweek for 3 months • Other Names: o Microgynon 30 o RVG 08204 Placebo comparator: Vitamin E • Vitamin E 400 IU oral capsules once daily for 3 months
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