Characteristics of female patients with migraine attacks associated with sex hormone fluctuations

Characteristics of female patients with migraine attacks associated with sex hormone fluctuations - The WHAT! - Diary Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45933

Enrollment

500

Registered

2019-02-07

Start date

2019-02-18

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

headache migraine

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female - At least 18 years of age - Migraine without aura, migraine with aura or chronic migraine (according to the International Classification of Headache Disorders ICHD-3b)

Exclusion criteria

Exclusion criteria: - Women who are pregnant or breastfeeding - Continuous combined oral contraceptive use and not willing to insert pill-free weeks during the study - Other continuous sex hormonal therapies (e.g. hormone-releasing intrauterine device, progesterone-only pill, Implanon NXT, Depo-Provera) - Spontaneous postmenopausal status (menstrual bleedings have ceased for 12 consecutive months) - History of unilateral or bilateral oophorectomy - History of hysterectomy - Current gynaecological malignancy

Design outcomes

Primary

Measure	Time frame
Migraine attack duration	—

Secondary

Measure	Time frame
Secondary study parameters: Clinical characteristics of migraine attacks: - Migraine attack severity - Migraine associated factors (photophobia, phonophobia, nausea, vomiting) - Aura symptoms - Efficacy of acute medication use: type and dosage - Migraine attack timing during menstrual cycle Hormone-related characteristics: - Menstrual cycle length - Premenstrual complaints based on Daily Record of Severity of Problems Tertiary study parameters: Clinical characteristics of migraine patients: - Migraine attack frequency per month - Number of migraine days per month - Number of headache days per month - Current prophylactic medication use: type and dosage - Current exogenous sex hormone use: type - Current climacteric symptoms based on Greene Climacteric Scale - Current premenstrual syndrome and/or premenstrual dysphoric disorder based on Daily Record of Severity of Problems - Current depression and anxiety symptoms based on HADS, CES-D, MASQ-30 - Menstrual cycle history - Obstetric history	—

Measure

Time frame

Secondary study parameters: Clinical characteristics of migraine attacks: - Migraine attack severity - Migraine associated factors (photophobia, phonophobia, nausea, vomiting) - Aura symptoms - Efficacy of acute medication use: type and dosage - Migraine attack timing during menstrual cycle Hormone-related characteristics: - Menstrual cycle length - Premenstrual complaints based on Daily Record of Severity of Problems Tertiary study parameters: Clinical characteristics of migraine patients: - Migraine attack frequency per month - Number of migraine days per month - Number of headache days per month - Current prophylactic medication use: type and dosage - Current exogenous sex hormone use: type - Current climacteric symptoms based on Greene Climacteric Scale - Current premenstrual syndrome and/or premenstrual dysphoric disorder based on Daily Record of Severity of Problems - Current depression and anxiety symptoms based on HADS, CES-D, MASQ-30 - Menstrual cycle history - Obstetric history

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Countries

Netherlands

Outcome results