Clinical trial NCT06509503: Impact of Combined Oral Contraceptive Pills on Migraine
Official title: Impact of Combined Oral Contraceptive Pills on Migraine, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Migraine
Keywords: migraine
combined oral contraception
Egypt
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The percentage of patients who achieved ≥ 50% change in the monthly migraine days frequency compared to the baseline frequency
timeFrame: 90 days
Secondary outcomes:
measure: The severity of migraine attack on VAS score after three months of treatment
timeFrame: 3 months
measure: HIT-6 score change in each group after three months of treatment
timeFrame: 3 months
measure: The monthly migraine days per month
timeFrame: 3 months
measure: The duration of migraine attack in hours after three months of treatment
timeFrame: 3 months
measure: percentage of phenotypic features after three months of treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafr Elsheikh University Hospital
Study officials:
References:
citation: Lipton RB, Scher AI, Kolodner K, Liberman J, Steiner TJ, Stewart WF. Migraine in the United States: epidemiology and patterns of health care use. Neurology. 2002 Mar 26;58(6):885-94. doi: 10.1212/wnl.58.6.885.
citation: Lipton RB, Liberman JN, Kolodner KB, Bigal ME, Dowson A, Stewart WF. Migraine headache disability and health-related quality-of-life: a population-based case-control study from England. Cephalalgia. 2003 Jul;23(6):441-50. doi: 10.1046/j.1468-2982.2003.00546.x.
citation: Mushet GR, Miller D, Clements B, Pait G, Gutterman DL. Impact of sumatriptan on workplace productivity, nonwork activities, and health-related quality of life among hospital employees with migraine. Headache. 1996 Mar;36(3):137-43. doi: 10.1046/j.1526-4610.1996.3603137.x.