Impact of Combined Oral Contraceptive Pills on Migraine
- Registration Number
- NCT06509503
- Lead Sponsor
- Kafrelsheikh University
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 400
- female migraine patients on COCs or mechanical contraceptive methods, according to the International Classification of Headache Disorders 3rd edition, aged 18-55 years
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description the COCs group 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. We will assess The change in migraine days per 28 days, the number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of treatment was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. We will assess the phenotypic features of migraine. the non-hormonal contraception group Vaginal Ring The arm will include 200 migraine patients diagnosed according to ICHD3-beta criteria. The patients are not receiving any hormonal contraception and will receive propranolol 80-160mg daily and ibuprofen 200-400 mg only in acute migraine attacks for 3 months. We will assess The change in migraine days per 28 days, the number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of treatment was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. We will assess the phenotypic features of migraine.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method The monthly migraine days per month 3 months The investigators will assess the change in migraine days per month in each group
The duration of migraine attack in hours after three months of treatment 3 months After three months of treatment, the investigators will assess the duration of migraine attacks in hours in each group
percentage of phenotypic features after three months of treatment 3 months After three months of treatment, the investigators will assess percentage of phenotypic features in each group.
The severity of migraine attack on VAS score after three months of treatment 3 months After three months of treatment, the investigators will assess the severity of migraine attacks on VAS scores.
VAS is a scale from one to ten where one is the least severe pain while ten is the most severest painHIT-6 score change in each group after three months of treatment 3 months The investigators assessed the absolute change in HIT6 score, the Headache Impact Test-6 (HIT-6) assessed the burden of headache in each group; the HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress, the patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often," or "always." These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent. It has four impact grades: little-to-no impact (HIT-6 score: 36-49), moderate impact (HIT-6 score: 50-55), substantial impact (HIT-6 score: 56-59), and severe impact (HIT-6 score: 60-78)
Trial Locations
- Locations (1)
Kafr Elsheikh University Hospital
🇪🇬Kafr Ash Shaykh, Egypt