Endometriosis, Migraine
Conditions
Keywords
CGRP
Brief summary
Migraine and endometriosis are common conditions that mainly affect females of reproductive age. Both can cause significant pain and have a strong impact on the quality of life. Increasing evidence suggests that these two conditions often occur together, and that females who have both may experience more severe symptoms than those with only one of them. However, the reasons why migraine and endometriosis are linked are still not well understood. Some biological factors may help explain this connection. One of them is a molecule called calcitonin gene-related peptide (CGRP), which plays an important role in migraine and may also be involved in pain and inflammation in endometriosis. In addition, hormonal changes during the menstrual cycle, especially fluctuations in estrogen levels, may influence symptoms in both conditions. Genetic and epigenetic factors may also contribute to this association. The main hypothesis of this study is that females who have both migraine and endometriosis have a distinct clinical and biological profile compared to females who have only migraine or only endometriosis. In particular, it is expected that differences will be observed in CGRP levels and hormonal patterns across the menstrual cycle. The FEMININE study is a prospective observational study that will follow females over several menstrual cycles. It will include three groups: females with both migraine and endometriosis, females with migraine only, and females with endometriosis only. Participants will record their symptoms in diaries and will provide blood samples at specific times of the menstrual cycle. The main goal of the study is to compare CGRP levels between groups. Additional goals include describing differences in symptoms, menstrual-related migraine, hormonal levels, and selected genetic and epigenetic markers. By improving the understanding of how migraine and endometriosis are related, this study aims to support better diagnosis and more personalized care for females affected by these conditions.
Interventions
None listed
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult females (≥18 years old). 2. Diagnosis of migraine according to ICHD-3 criteria confirmed by a headache specialist (for MIG-O and MIG-EDM groups). 3. Confirmed diagnosis of endometriosis based on clinical symptoms and imaging or surgical criteria according to ESHRE guidelines (for EDM-O and MIG-EDM groups). 4. Signed informed consent.
Exclusion criteria
1. Individuals diagnosed with secondary headache according to the ICHD-3. 2. Individuals with a severe disease (e.g., major psychiatric disorder, severe cardiovascular conditions). 3. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months. 4. Pregnant or breastfeeding females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pattern of serum CGRP levels across menstrual phases | During the first 3 menstrual cycles, up to 6 months if extension is needed | Serum CGRP levels measured during the periovulatory and perimenstrual phases and compared among females with comorbid migraine and endometriosis, migraine only, and endometriosis only. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Migraine frequency | Baseline through completion of follow-up, up to 6 months | Monthly headache days recorded in the headache diary. |
| Acute medication use | Baseline through completion of follow-up, up to 6 months | Number of acute medication intake days per month recorded in the headache diary. |
| Migraine-related disability | Baseline and end of study, up to 6 months | Headache Impact Test-6 (HIT-6) score in participants with migraine. |
| Menstrually related migraine features | During follow-up, up to 6 months | Prevalence and clinical characteristics of menstrually related migraine based on diary data. |
| Endometriosis-related quality of life | Baseline and end of study, up to 6 months | The short form endometriosis health profile questionnaire (EHP-5) in participants with endometriosis |
| Endometriosis-related pain symptoms | Baseline through completion of follow-up, up to 6 months | Frequency and severity of dysmenorrhea, dyspareunia, dyschezia, dysuria, and pelvic pain assessed during study visits and diaries. |
| Serum sex hormone levels | During predefined menstrual phases across follow-up, up to 6 months | Serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, testosterone, and prolactin. |
| Association between CGRP and hormonal levels | During follow-up, up to 6 months | Association between serum CGRP levels and serum hormonal levels across predefined menstrual phases. |
| Genetic markers | Baseline | Genotype distribution of predefined candidate polymorphisms in genes related to CGRP signaling, hormonal pathways, and endometriosis susceptibility. |
| Epigenetic markers | Baseline | DNA methylation levels in predefined candidate regulatory regions related to inflammatory and hormonal pathways. |
Countries
Spain
Contacts
CONTACTPatricia Pozo-Rosich, Professor
Outcome results
None listed