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Continuous combined oral contraceptive use versus vitamin E in the treatment of menstrual migraine: rationale and protocol of a randomized controlled trial (WHAT!).
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- معلومة اضافية
- المصدر:
Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
- بيانات النشر:
Original Publication: [London] : BioMed Central, 2006-
- الموضوع:
- نبذة مختصرة :
Background: Currently, there is no evidence-based hormonal treatment for migraine in women. Several small studies suggest a beneficial effect of combined oral contraceptives, but no large randomized controlled trial has been performed. As proof of efficacy is lacking and usage may be accompanied by potentially severe side effects, there is a great need for clarity on this topic.
Methods: Women with menstrual migraine (n = 180) are randomly assigned (1:1) to ethinylestradiol/levonorgestrel 30/150 μg or vitamin E 400 IU. Participants start with a baseline period of 4 weeks, which is followed by a 12-week treatment period. During the study period, a E-headache diary will be used, which is time-locked and includes an automated algorithm differentiating headache and migraine days.
Results: The primary outcome will be change in monthly migraine days (MMD) from baseline (weeks - 4 to 0) to the last 4 weeks of treatment (weeks 9 to 12). Secondary outcomes will be change in monthly headache days (MHD) and 50% responder rates of MMD and MHD.
Conclusions: The WHAT! trial aims to investigate effectivity and safety of continuous combined oral contraceptive treatment for menstrual migraine. Immediate implementation of results in clinical practice is possible.
Trial Registration: Clinical trials.gov NCT04007874 . Registered 28 June 2019.
(© 2024. The Author(s).)
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- Grant Information:
849200007 Netherlands ZONMW_ ZonMw
- Contributed Indexing:
Keywords: Combined oral contraceptive pill; Headache; Hormones; Migraine; Treatment
- Molecular Sequence:
ClinicalTrials.gov NCT04007874
- الرقم المعرف:
0 (Contraceptives, Oral, Combined)
- الموضوع:
Date Created: 20240215 Date Completed: 20240219 Latest Revision: 20240219
- الموضوع:
20240219
- الرقم المعرف:
PMC10870678
- الرقم المعرف:
10.1186/s13063-024-07955-8
- الرقم المعرف:
38360739
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