Impact of Combined Oral Contraceptive Pills on Migraine

NCT06509503 | Recruiting Phase 4

• 1 other identifier: 091287
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

migraine; combined oral contraception; Egypt

Outcome Measures

Primary Outcomes (1)

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

  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

  90 days

Secondary Outcomes (5)

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

  3 months

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

  3 months

• The monthly migraine days per month

  3 months

• The duration of migraine attack in hours after three months of treatment

  3 months

• percentage of phenotypic features after three months of treatment

  3 months

Study Arms (2)

the COCs group

ACTIVE COMPARATOR

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.

Drug: Combined oral contraceptive

the non-hormonal contraception group

ACTIVE COMPARATOR

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.

Drug: Vaginal Ring

Interventions

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.

the COCs group

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.

the non-hormonal contraception group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female migraine patients on COCs or mechanical contraceptive methods, according to the International Classification of Headache Disorders 3rd edition, aged 18-55 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, 33511, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 11914403 RESULT

• 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.

  PMID: 12807523 RESULT

• 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.

  PMID: 8984084 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

Contraceptives, Oral, Combined; Contraceptive Devices, Female

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Contraceptive Devices; Equipment and Supplies

Central Study Contacts

mohamed G. Zeinhom, MD

CONTACT

2001009606828; mohamed_gomaa@med.kfs.edu.eg

sherihan R. ahmed, MD

CONTACT

2001113432342; sherihan_rezq@med.kfs.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 19, 2024
• Study Start: July 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: July 30, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)