Migraine and Endometriosis: The FEMININE Study

Starting soon

Conditions studied: Migraine, Endometriosis

In brief

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.

Key facts

Study ID

NCT07519343

Run by

Hospital Universitari Vall d'Hebron Research Institute

People needed

150

Starts

2026-06-01

Expected to finish

2028-06-01

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult females (≥18 years old).
• Diagnosis of migraine according to ICHD-3 criteria confirmed by a headache specialist (for MIG-O and MIG-EDM groups).
• Confirmed diagnosis of endometriosis based on clinical symptoms and imaging or surgical criteria according to ESHRE guidelines (for EDM-O and MIG-EDM groups).
• Signed informed consent.

You may not qualify if…

• Individuals diagnosed with secondary headache according to the ICHD-3.
• Individuals with a severe disease (e.g., major psychiatric disorder, severe cardiovascular conditions).
• History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months.
• Pregnant or breastfeeding females.

Where it is running

• Vall d'Hebron University Hospital — Barcelona, Spain

Full record on ClinicalTrials.gov

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