Oral Contraceptive Pill Compared With Vitamin E in Women With Migraine
NCT ID: NCT04007874
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2019-09-10
2024-12-31
Brief Summary
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Detailed Description
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Objective: 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 menstrually-related and perimenopausal migraine.
Study design: Open-label randomized controlled trial. Study population: Women with menstrually-related or pure menstrual migraine and women with perimenopausal migraine.
Intervention: Continuous daily use of ethinylestradiol/levonorgestrel (30/150 µg/day) compared with vitamin E (400 IU/day).
Primary endpoint: Change in monthly migraine days from baseline to the last 4 weeks of treatment (weeks 9-12).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study will encompass a period of 4 months (1 baseline month and 3 treatment months). Patients have to fill out daily headache diaries throughout the study using a web-based app (≈ 5 min). Patients visit the headache clinic thrice, once for inclusion, once during the baseline period and once after 3 months of therapy (duration ≈ 1 hour). During the first and last visit blood samples will be taken. Patients will be contacted twice during follow-up to evaluate (S)AE's. Treatment with the oral contraceptive pill is accompanied by a very low risk of developing thromboembolisms. Participation might benefit participants by reducing their migraine attack frequency or intensity.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Ethinylestradiol/levonorgestrel
Ethinylestradiol/levonorgestrel 30/150 µg oral tablets once daily without a stopweek for 3 months
Ethinylestradiol/levonorgestrel
Ethinylestradiol/levonorgestrel 30/150 µg oral tablets once daily without a stopweek for 3 months
Vitamin E
Vitamin E 400 IU oral capsules once daily for 3 months
Vitamin E
Vitamin E 400 IU oral capsules once daily for 3 months
Interventions
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Ethinylestradiol/levonorgestrel
Ethinylestradiol/levonorgestrel 30/150 µg oral tablets once daily without a stopweek for 3 months
Vitamin E
Vitamin E 400 IU oral capsules once daily for 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Erasmus Medical Center
OTHER
Netherlands Brain Foundation
OTHER
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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G.M. Terwindt, MD
Head of headache clinic, Principal Investigator
Principal Investigators
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Gisela M Terwindt, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
LUMC
Locations
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Leiden University Medical Center
Leiden, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Britt WH van der Arend, MD
Role: primary
References
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van der Arend BWH, van Casteren DS, Verhagen IE, MaassenVanDenBrink A, Terwindt GM. Continuous combined oral contraceptive use versus vitamin E in the treatment of menstrual migraine: rationale and protocol of a randomized controlled trial (WHAT!). Trials. 2024 Feb 15;25(1):123. doi: 10.1186/s13063-024-07955-8.
Other Identifiers
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2018-004096-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WHATT
Identifier Type: -
Identifier Source: org_study_id