RecruitingPhase 4NCT06509503

Impact of Combined Oral Contraceptive Pills on Migraine

Impact of Combined Oral Contraceptive Pills on Migraine, a Randomized Controlled Trial

Sponsor

Kafrelsheikh University

Enrollment

400 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

Migraine

Summary

The investigators will assess the effect of combined oral contraceptive pills (COCs) on migraine features and treatment response to allow better interpretation of the exact consequence of hormonal contraceptive use on migraineurs.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria1

female migraine patients on COCs or mechanical contraceptive methods, according to the International Classification of Headache Disorders 3rd edition, aged 18-55 years

Exclusion Criteria3

Patients with major neurological conditions such as (epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, and brain tumors).
pregnant, lactating, and menopausal patients.
Patients with any contraindications to ibuprofen or propranolol.

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Interventions

DRUGCombined oral contraceptive

The arm will include 200 migraine patients diagnosed according to ICHD3-beta criteria. The patients are regular users of COCs and will receive propranolol 80-160mg daily and ibuprofen 200-400 mg only in acute migraine attacks for 3 months.

DRUGVaginal Ring

The arm will include 200 migraine patients diagnosed according to ICHD3-beta criteria. The patients are users of mechanical contraceptive methods and will receive propranolol 80-160mg daily and ibuprofen 200-400 mg only in acute migraine attacks for 3 months.