headache migraine
Conditions
Interventions
Continuous ethinylestradiol/levonorgestrel 30/150 µg/day versus vitamin E 400
IU/day
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - female - menstrually-related migraine OR migraine in the early menopausal transition phase - age >= 18 - demonstrated at least 80% compliance with eDiary during baseline period - no or stable for at least two months on prophylactic medication
Exclusion criteria
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 with 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 with 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of monthly migraine days | — |
Secondary
| Measure | Time frame |
|---|---|
| - number of monthly headache days - number of monthly migraine and probable migraine attacks - 50% response rates for migraine days - number of (severe) adverse events | — |
Countries
Netherlands
Outcome results
None listed