G43.0 G43.1
Conditions
Interventions
Group 1: Women with episodic migraine and combined oral contraceptives
Group 2: Women with episodic migraine without hormonal treatment
Group 3: Healthy women (without migraine) with combined oral con
Sponsors
Charité Campus Charité Mitte
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria - Migraine Groups: - Confirmed episodic migraine according to the International Headache Society (IHS) criteria - At least 4 migraine attacks in the 28 days prior to study inclusion. Inclusion criteria - COC groups: - Taking a COC for at least 3 months at a stable dose and on a conventional cycle (21 days of intake and 7 days off) Inclusion criteria - women without a COC: - Regular menstrual cycle (stable cycle length +-2 days over the last 3 cycles). Inclusion criteria - postmenopausal groups: - last menstrual period at least 5 years ago.
Exclusion criteria
Exclusion criteria: Exclusion criteria: - BMI < 17 or above 30 kg/m2 - History of gynecological or urological disease - History of other headache disorder (except max. 2 days tension-type headache/month) - Intake of migraine prophylactic medication - Pregnancy or lactation - Continuous hormonal contraception without hormone-free interval.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CGRP concentrations in plasma and tear fluid in female migraine patients with and without COC | — |
Secondary
| Measure | Time frame |
|---|---|
| - CGRP concentrations in plasma and tear fluid in female migraine patients on COC compared with healthy female control subjects on COC. - CGRP concentrations in plasma and tear fluid in female migraine patients without COC compared with healthy female control subjects without COC. - CGRP concentrations in plasma and tear fluid in postmenopausal female migraine patients compared with premenopausal migraine patients - CGRP concentrations in plasma and tear fluid in postmenopausal female migraine patients compared with healthy female postmenopausal control subjects. - CGRP concentrations in plasma and tear fluid in male migraine patients compared with healthy male control subjects. - Evidence of a positive correlation between CGRP concentrations in plasma and tear fluid and estradiol concentrations in peripheral blood. - Evidence of a positive correlation between CGRP concentrations in plasma and tear fluid and progesterone concentrations in peripheral blood. - Evidence of a positive correlation between CGRP concentrations in plasma and tear fluid and testosterone concentrations in peripheral blood. | — |
Countries
Germany
Contacts
Public ContactBianca Raffaelli
Charité - Universitätsmedizin BerlinKlinik für Neurologie
Outcome results
None listed