NCT06509503

Impact of Combined Oral Contraceptive Pills on Migraine

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators will use a questionnaire to detect the migraineur demographic and clinical features (disease duration, attack frequency and duration, pain intensity assessed by visual analogic scale, HIT score in female patients on regular COCs * Special emphasis was put on clinical phenotype (for example, the character of pain, location, associated symptoms, etc.); vascular risk factors (hypertension, diabetes, smoking); history of cerebrovascular events and other conditions (collagen disorders, hepatic disorders, blood diseases, heart, kidneys), and family history. * All the patients will undergo clinical neurological and general physical examinations, and migraine history and associated phenotypic features will be established.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Combined 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.
DRUG	Vaginal 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.

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-05-15
• Completion: 2025-07-30
• First posted: 2024-07-19
• Last updated: 2024-10-09

Locations

1 site across 1 country: Egypt