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The role of sex hormones in the provocation of migraine attacks in female migraine patients

Recruiting
Conditions
Migraine
10019231
Registration Number
NL-OMON52784
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
132
Inclusion Criteria

- Women aged >= 18 years
- Menstrual migraine OR Early menopausal transition phase
- Migraine frequency: >= 1 attack/month
- Regular menstrual cycle with a cycle length between 25-32 days OR LH surge
between days 5 and 25 of the menstrual cycle
- Normal, mildly increased or decreased BMI

Exclusion Criteria

- Insufficient mastery of Dutch
- Inability to complete the electronic diary in an accurate manner
- Smoking
- Chronic migraine
- Medication-overuse headache (ICHD-3 criteria)
- Women who are breastfeeding, pregnant, or planning to become pregnant
- Oral contraceptive use during the last month and not willing to undergo
washout period (stop for one month)
- Other sex hormone containing treatment use during the last month
- Use of corticosteroids during the last month
- Anamnestic signs of anemia
- Any serious illness that can compromise study participation
- Freezer of insufficient quality

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Serum levels of estradiol during days 8, 10, 12 and 14 after the LH surge</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Serum levels of progesterone during days 8, 10, 12 and 14 after the LH surge<br /><br>Serum levels of estradiol and progesterone during days 1, 2 and 3 after the LH<br /><br>surge<br /><br>Serum levels of 17-hydroxyprogesterone, testosterone, dihydrotestosterone,<br /><br>androstenedione, DHEA, DHEAS, SHBG, LH, FSH and CGRP during days 1, 2, 3, 8,<br /><br>10, 12 and 14 after the LH surge.</p><br>
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