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NCT06509503 | RECRUITING | Migraine

Impact of Combined Oral Contraceptive Pills on Migraine
Sponsor:

Kafrelsheikh University

Information provided by (Responsible Party):

Sherihan Rezk Ahmed

Brief 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.

Condition or disease

Migraine

Intervention/treatment

Combined oral contraceptive

Vaginal Ring

Phase

PHASE4

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 400 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Impact of Combined Oral Contraceptive Pills on Migraine, a Randomized Controlled Trial
Actual Study Start Date : 2024-07-15
Estimated Primary Completion Date : 2025-05-15
Estimated Study Completion Date : 2025-07-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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.
Impact of Combined Oral Contraceptive Pills on Migraine

Location Details

NCT06509503

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Locations

RECRUITING

Egypt,

Kafr Elsheikh University Hospital

Kafr ash Shaykh, Egypt, 33511