To compare serum estradiol levels during the late luteal phase between 1) women with menstrually-related or pure menstrual migraine and premenopausal controls and 2) perimenopausal migraine patients and perimenopausal controls. Secondary objectives…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum levels of estradiol during days 8, 10, 12 and 14 after the LH surge
Secondary outcome
Serum levels of progesterone during days 8, 10, 12 and 14 after the LH surge
Serum levels of estradiol and progesterone during days 1, 2 and 3 after the LH
surge
Serum levels of 17-hydroxyprogesterone, testosterone, dihydrotestosterone,
androstenedione, DHEA, DHEAS, SHBG, LH, FSH and CGRP during days 1, 2, 3, 8,
10, 12 and 14 after the LH surge.
Background summary
The prevalence of migraine is three times higher in women than men. Clinical
and epidemiological studies suggest a prominent role for sex hormones in female
migraine patients. Menstruation is an important factor increasing the
susceptibility for an upcoming attack. Perimenstrual migraine attacks are also
more disabling, longer lasting, and more difficult to treat than other attacks.
Hormonal fluctuations during menopausal transition are also associated with
increased susceptibility for migraine. Thus, sex hormonal conditions are known
to affect the susceptibility for migraine attacks in women, but there is a lack
of understanding of the underlying pathophysiological mechanism.
Study objective
To compare serum estradiol levels during the late luteal phase between 1) women
with menstrually-related or pure menstrual migraine and premenopausal controls
and 2) perimenopausal migraine patients and perimenopausal controls. Secondary
objectives are to compare additional serum sex hormone levels (see parameters
for the exact hormones) during the late follicular phase and the luteal phase.
Study design
Observational study in migraine patients and healthy controls
Study burden and risks
Risks related to venapuncture (pain / hematoma). A total of 560ml blood will be
collected throughout two subsequent menstrual cycles. This does not pose any
health risks. When donating blood a volume of 500ml is collected at once.
cantaloupenburg 19
Den Haag 2514KJ
NL
cantaloupenburg 19
Den Haag 2514KJ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL74161.058.20 |