An observational study in Migraine and Endometriosis, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Not yet recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 150 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited from prospectively maintained clinical databases at Vall d'Hebron University Hospital (Headache Unit and Gynecology Unit) and from outpatient clinics specialized in migraine and endometriosis. The study population consists of adult females of reproductive age with a diagnosis of migraine, endometriosis, or both, who are receiving routine clinical care at a tertiary referral center.
Exclusion Criteria:
Females with a diagnosis of both migraine (ICHD-3 criteria) and endometriosis (ESHRE criteria)
Females with a diagnosis of migraine (ICHD-3 criteria) and no history of endometriosis.
Females with a diagnosis of endometriosis (ESHRE criteria) and no history of migraine.
Pattern of serum CGRP levels across menstrual phases
Serum CGRP levels measured during the periovulatory and perimenstrual phases and compared among females with comorbid migraine and endometriosis, migraine only, and endometriosis only.
Time frame: During the first 3 menstrual cycles, up to 6 months if extension is needed
Migraine frequency
Monthly headache days recorded in the headache diary.
Time frame: Baseline through completion of follow-up, up to 6 months
Acute medication use
Number of acute medication intake days per month recorded in the headache diary.
Time frame: Baseline through completion of follow-up, up to 6 months
Migraine-related disability
Headache Impact Test-6 (HIT-6) score in participants with migraine.
Time frame: Baseline and end of study, up to 6 months
Menstrually related migraine features
Prevalence and clinical characteristics of menstrually related migraine based on diary data.
Time frame: During follow-up, up to 6 months
Endometriosis-related quality of life
The short form endometriosis health profile questionnaire (EHP-5) in participants with endometriosis
Time frame: Baseline and end of study, up to 6 months
Endometriosis-related pain symptoms
Frequency and severity of dysmenorrhea, dyspareunia, dyschezia, dysuria, and pelvic pain assessed during study visits and diaries.
Time frame: Baseline through completion of follow-up, up to 6 months
Serum sex hormone levels
Serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, testosterone, and prolactin.
Time frame: During predefined menstrual phases across follow-up, up to 6 months
Association between CGRP and hormonal levels
Association between serum CGRP levels and serum hormonal levels across predefined menstrual phases.
Time frame: During follow-up, up to 6 months
Genetic markers
Genotype distribution of predefined candidate polymorphisms in genes related to CGRP signaling, hormonal pathways, and endometriosis susceptibility.
Time frame: Baseline
Epigenetic markers
DNA methylation levels in predefined candidate regulatory regions related to inflammatory and hormonal pathways.
Time frame: Baseline
Plan to share: No — Access to de-identified individual participant data may be granted to researchers upon reasonable request, pending ethical approval and the execution of appropriate data sharing agreements.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute