Open-label Randomized Controlled Trial for the Effects of Continuous Ethinylestradiol/Levonorgestrel (30/150 μg/Day) Compared With Vitamin E (400 IU/Day) in the Treatment of Menstrually-related Migraine and Migraine During Perimenopause
Who is this study for? Patients with menstrually-related migraine and migraine during perimenopause
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Contact Information
Primary
Britt WH van der Arend, MSc
B.W.H.van_der_Arend@lumc.nl
+31715266065
Time Frame
Start Date: 2019-09-10
Estimated Completion Date: 2024-12
Participants
Target number of participants: 360
Treatments
Experimental: Ethinylestradiol/levonorgestrel
Ethinylestradiol/levonorgestrel 30/150 µg oral tablets once daily without a stopweek for 3 months
Active_comparator: Vitamin E
Vitamin E 400 IU oral capsules once daily for 3 months
Sponsors
Leads: Leiden University Medical Center
Collaborators: Netherlands Brain Foundation, Erasmus Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development