Impact of Combined Oral Contraceptive Pills on Migraine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-07-30

Brief Summary

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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.

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Detailed Description

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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

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We have two groups; the first group will include 200 patients who received COCs, while the second group will receive mechanical contraception We will assess 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 and the phenotypic features of migraine in each group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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the COCs group

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.

Group Type ACTIVE_COMPARATOR

Combined oral contraceptive

Intervention Type DRUG

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.

the non-hormonal contraception group

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.

Group Type ACTIVE_COMPARATOR

Vaginal Ring

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No