Migraine and Endometriosis: The FEMININE Study

N/ANot Yet RecruitingNCT07519343

Hospital Universitari Vall d'Hebron Research Institute150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Migraine

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Migraine and Endometriosis: The FEMININE Study

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts