Oral Contraceptive Pill Compared With Vitamin E in Women With Migraine (NCT04007874) | Clinical Trial Compass
UnknownPhase 3
Oral Contraceptive Pill Compared With Vitamin E in Women With Migraine
Netherlands360 participantsStarted 2019-09-10
Plain-language summary
Open-label randomized controlled trial to study the efficacy of continuous daily use of ethinylestradiol/levonorgestrel (30/150 µg/day) compared with vitamin E (400 IU/day) in the treatment of women with menstrually-related and perimenopausal migraine.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female
* Premenopausal with menstrual migraine OR migraine during the early menopausal transition phase (a difference of 7 days or more in length of consecutive cycles, which should occur at least twice in a period of 12 menstrual cycles)
* Demonstrated at least 80% compliance with eDiary 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, en…
What they're measuring
1
Number of migraine days
Timeframe: From baseline to the last 4 weeks of treatment (weeks 9-12)