Oral Contraceptive Pill Compared With Vitamin E in Women With Migraine

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Collaborators: Erasmus Medical Center; Hersenstichting; Netherlands Brain Foundation; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: alpha-Tocopherol; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Levonorgestrel; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

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, 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