Impact of Combined Oral Contraceptive Pills on Migraine

NCT06509503 · tracked via the Priya Life Science Egypt tracker

Sponsor

Kafrelsheikh University

Phase

Phase 4

Started

2024-07-15

Last updated

2024-10-09

Condition(s) studied

Migraine

Investigational drug(s) / intervention(s)

Combined oral contraceptive →Vaginal Ring

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.

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.

Study 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

FEMALE

Min age

18 Years

Max age

55 Years

Healthy volunteers

Inclusion Criteria: * female migraine patients on COCs or mechanical contraceptive methods, according to the International Classification of Headache Disorders 3rd edition, aged 18-55 years Exclusion Criteria: 1. Patients with major neurological conditions such as (epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, and brain tumors). 2. pregnant, lactating, and menopausal patients. 3. Patients with any contraindications to ibuprofen or propranolol.

Primary outcome measure(s)

The percentage of patients who achieved ≥ 50% change in the monthly migraine days frequency compared to the baseline frequency — 90 days
We will assess The percentage of patients who achieved ≥ 50% change in the monthly headache days frequency compared to the baseline frequency in each group

Trial sites (1)

Facility	City	Region	Status
Kafr Elsheikh University Hospital	Kafr ash Shaykh	Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06509503 on ClinicalTrials.gov ↗ ← All trials in Egypt