Migraine and Endometriosis: The FEMININE Study

Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Study ID
NCT07519343
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Apr 9, 2026
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Migraine and Endometriosis (MIG-EDM)
    Females with a diagnosis of both migraine (ICHD-3 criteria) and endometriosis (ESHRE criteria)
  • Arm: Migraine Only (MIG-O)
    Females with a diagnosis of migraine (ICHD-3 criteria) and no history of endometriosis.
  • Arm: Endometriosis Only (EDM-O)
    Females with a diagnosis of endometriosis (ESHRE criteria) and no history of migraine.

Primary Outcome Measure

Pattern of serum CGRP levels across menstrual phases [ Time Frame: During the first 3 menstrual cycles, up to 6 months if extension is needed ]

Central Contacts

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