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

Phase 3

Recruiting

• Conditions: headache; migraine; 10019231

• Registration Number: NL-OMON52418
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 360

Inclusion Criteria

- female
- menstrually-related migraine OR migraine in the early menopausal transition
phase
- age >= 18
- 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 with 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 with 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of monthly migraine days </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- number of monthly headache days<br /><br>- number of monthly migraine and probable migraine attacks<br /><br>- 50% response rates for migraine days<br /><br>- number of (severe) adverse events</p><br>