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NCT Number: NCT07519343

Migraine and Endometriosis: The FEMININE Study

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Pattern of serum CGRP levels across menstrual phases

    Time frame: During the first 3 menstrual cycles, up to 6 months if extension is needed

    Serum CGRP levels measured during the periovulatory and perimenstrual phases and compared among females with comorbid migraine and endometriosis, migraine only, and endometriosis only.

Secondary outcomes

  1. Migraine frequency

    Time frame: Baseline through completion of follow-up, up to 6 months

    Monthly headache days recorded in the headache diary.

  2. Acute medication use

    Time frame: Baseline through completion of follow-up, up to 6 months

    Number of acute medication intake days per month recorded in the headache diary.

  3. Migraine-related disability

    Time frame: Baseline and end of study, up to 6 months

    Headache Impact Test-6 (HIT-6) score in participants with migraine.

  4. Menstrually related migraine features

    Time frame: During follow-up, up to 6 months

    Prevalence and clinical characteristics of menstrually related migraine based on diary data.

  5. Endometriosis-related quality of life

    Time frame: Baseline and end of study, up to 6 months

    The short form endometriosis health profile questionnaire (EHP-5) in participants with endometriosis

  6. Endometriosis-related pain symptoms

    Time frame: Baseline through completion of follow-up, up to 6 months

    Frequency and severity of dysmenorrhea, dyspareunia, dyschezia, dysuria, and pelvic pain assessed during study visits and diaries.

  7. Serum sex hormone levels

    Time frame: During predefined menstrual phases across follow-up, up to 6 months

    Serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, testosterone, and prolactin.

  8. Association between CGRP and hormonal levels

    Time frame: During follow-up, up to 6 months

    Association between serum CGRP levels and serum hormonal levels across predefined menstrual phases.

  9. Genetic markers

    Time frame: Baseline

    Genotype distribution of predefined candidate polymorphisms in genes related to CGRP signaling, hormonal pathways, and endometriosis susceptibility.

  10. Epigenetic markers

    Time frame: Baseline

    DNA methylation levels in predefined candidate regulatory regions related to inflammatory and hormonal pathways.

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Pozo-Rosich, Professor

CONTACT

[email protected]

+34 934 89 30 00

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Investigating the inFluence of EndoMetriosis IN migraINE - FEMININE Study

Acronym: FEMININE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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