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Oral Contraceptive Pill Compared With Vitamin E in Women With Migraine

NCT04007874 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2023-12-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ethinylestradiol/levonorgestrel

Ethinylestradiol/levonorgestrel 30/150 µg oral tablets once daily without a stopweek for 3 months

DRUG

Vitamin E

Vitamin E 400 IU oral capsules once daily for 3 months

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER

  • Netherlands Brain Foundation

    collaborator OTHER

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Gisela M Terwindt, MD,PhD · LUMC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-10
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04007874 on ClinicalTrials.gov