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NCT Number: NCT06509503

Impact of Combined Oral Contraceptive Pills on Migraine

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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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Combined oral contraceptive

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.

Vaginal Ring

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.

Primary outcomes

  1. The percentage of patients who achieved ≥ 50% change in the monthly migraine days frequency compared to the baseline frequency

    Time frame: 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 outcomes

  1. The severity of migraine attack on VAS score after three months of treatment

    Time frame: 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 pain

  2. HIT-6 score change in each group after three months of treatment

    Time frame: 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)

  3. The monthly migraine days per month

    Time frame: 3 months

    The investigators will assess the change in migraine days per month in each group

  4. The duration of migraine attack in hours after three months of treatment

    Time frame: 3 months

    After three months of treatment, the investigators will assess the duration of migraine attacks in hours in each group

  5. percentage of phenotypic features after three months of treatment

    Time frame: 3 months

    After three months of treatment, the investigators will assess percentage of phenotypic features in each group.

Study contacts

Contact information is provided by the study sponsor or research team.

mohamed G. Zeinhom, MD

CONTACT

[email protected]

2001009606828

sherihan R. ahmed, MD

CONTACT

[email protected]

2001113432342

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Impact of Combined Oral Contraceptive Pills on Migraine, a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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