MigrainePhase 4NCT06509503
Impact of Combined Oral Contraceptive Pills on Migraine
A Phase 4 study testing Combined oral contraceptive and Vaginal Ring in people with Migraine, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Migraine
- What is being tested?
- Combined oral contraceptive and Vaginal Ring
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2024to 30 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female migraine patients on COCs or mechanical contraceptive methods, according to the International Classification of Headache Disorders 3rd edition, aged 18-55 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kafr Elsheikh University Hospital
Kafr ash Shaykh, 33511
mohamed G. Zeinhom, MD, 2001009606828, mohamed_gomaa@med.kfs.edu.eg
sherihan R. ahmed, MD, 2001007481842, sherihan_rezq@med.kfs.edu.eg
About this study
Official title: Impact of Combined Oral Contraceptive Pills on Migraine, a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Combined oral contraceptive, Vaginal Ring
- Keywords
- migraine, combined oral contraception, Egypt
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined oral contraceptiveDrug
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 RingDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Vaginal Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (5)
The severity of migraine attack on VAS score after three months of treatment
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
Measured: 3 months
HIT-6 score change in each group after three months of treatment
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)
Measured: 3 months
The monthly migraine days per month
The investigators will assess the change in migraine days per month in each group
Measured: 3 months
The duration of migraine attack in hours after three months of treatment
After three months of treatment, the investigators will assess the duration of migraine attacks in hours in each group
Measured: 3 months
percentage of phenotypic features after three months of treatment
After three months of treatment, the investigators will assess percentage of phenotypic features in each group.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start15 Jul 2024
- Primary completion15 May 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherihan Rezk Ahmed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509503
- Sponsor's protocol ID
- 091287
- Status last verified
- Oct 2024
- First submitted
- 13 Jul 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the data supporting this research's findings may be available from Sherihan R.Ahmed, upon reasonable request
Publications
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.
PubMed 11914403Lipton 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.
PubMed 12807523Mushet 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.
PubMed 8984084
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Combined Oral Contraceptive Pills on Migraine, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06509503
- Acronym / sponsor ID
- 091287
- Conditions
- Migraine
- Keywords
- migraine, combined oral contraception, Egypt
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| the COCs group | Active comparator | Drug: Combined oral contraceptiveThe 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 | Active comparator | Drug: Vaginal RingThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female migraine patients on COCs or mechanical contraceptive methods, according to the International Classification of Headache Disorders 3rd edition, aged 18-55 years
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined oral contraceptiveThe 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. | Drug | the COCs group |
| Vaginal RingThe 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. | Drug | the non-hormonal contraception group |
Primary outcome
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
5 secondary outcomes
The severity of migraine attack on VAS score after three months of treatment
Time frame: 3 months
HIT-6 score change in each group after three months of treatment
Time frame: 3 months
The monthly migraine days per month
Time frame: 3 months
The duration of migraine attack in hours after three months of treatment
Time frame: 3 months
percentage of phenotypic features after three months of treatment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Results publication: PubMed 11914403Lipton 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.
- Results publication: PubMed 12807523Lipton 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.
- Results publication: PubMed 8984084Mushet 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.
- Individual participant dataSharing planned: No. All the data supporting this research's findings may be available from Sherihan R.Ahmed, upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combined oral contraceptive and Vaginal Ring in people with Migraine, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed G. Zeinhom, MD (2001009606828, mohamed_gomaa@med.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients who achieved ≥ 50% change in the monthly migraine days frequency compared to the baseline frequency (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06509503, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.