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NCT07519343Not yet recruiting

Migraine and Endometriosis: The FEMININE Study

Investigating the inFluence of EndoMetriosis IN migraINE - FEMININE Study

Source: ClinicalTrials.gov · Last updated 9 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
2 Apr 2026
Start date
1 Jun 2026
Primary completion date
1 Jun 2028
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
NCT number
NCT07519343

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 1 Jun 2026 to the primary completion date, 1 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • Individuals diagnosed with secondary headache according to the ICHD-3.
  • Pregnant or breastfeeding females.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vall d'Hebron University Hospital
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.