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MigraineFEMININENCT07519343

Migraine and Endometriosis: The FEMININE Study

An observational study of Migraine and Endometriosis, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Migraine, Endometriosis
How many people
150 participants
Where
1 siteSpain
Study dates
1 Jun 2026to 1 Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants will be recruited from prospectively maintained clinical databases at Vall d'Hebron University Hospital (Headache Unit and Gynecology Unit) and from outpatient clinics specialized in migraine and endometriosis. The study population consists of adult females of reproductive age with a diagnosis of migraine, endometriosis, or both, who are receiving routine clinical care at a tertiary referral center.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Patricia Pozo-Rosich, Professor contact

+34 934 89 30 00

patricia.pozo@vallhebron.cat

Spain1 site

  • Vall d'Hebron University Hospital

    Barcelona, 08035

    Headache Unit, +34 678876997, cefalea@vallhebron.cat

Other trials in Spain

About this study

Official title: Investigating the inFluence of EndoMetriosis IN migraINE - 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.

Read more

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.

Keywords
CGRP
Medical subject headings
Migraine Disorders, Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07519343
Study groupRoleWhat they receive
Migraine and Endometriosis (MIG-EDM)Females with a diagnosis of both migraine (ICHD-3 criteria) and endometriosis (ESHRE criteria)
Migraine Only (MIG-O)Females with a diagnosis of migraine (ICHD-3 criteria) and no history of endometriosis.
Endometriosis Only (EDM-O)Females with a diagnosis of endometriosis (ESHRE criteria) and no history of migraine.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (10)

  1. Migraine frequency

    Monthly headache days recorded in the headache diary.

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

  2. Acute medication use

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

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

  3. Migraine-related disability

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

    Measured: Baseline and end of study, up to 6 months

  4. Menstrually related migraine features

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

    Measured: During follow-up, up to 6 months

  5. Endometriosis-related quality of life

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

    Measured: Baseline and end of study, up to 6 months

  6. Endometriosis-related pain symptoms

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

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

  7. Serum sex hormone levels

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

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

  8. Association between CGRP and hormonal levels

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

    Measured: During follow-up, up to 6 months

  9. Genetic markers

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

    Measured: Baseline

  10. Epigenetic markers

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07519343
Sponsor's protocol ID
FEMININE-2026-01
Acronym
FEMININE
Status last verified
Apr 2026
First submitted
2 Apr 2026
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Access to de-identified individual participant data may be granted to researchers upon reasonable request, pending ethical approval and the execution of appropriate data sharing agreements.

Publications

  • Fattori V, Zaninelli TH, Rasquel-Oliveira FS, Heintz OK, Jain A, Sun L, Seshan ML, Peterse D, Lindholm AE, Anchan RM, Verri WA Jr, Rogers MS. Nociceptor-to-macrophage communication through CGRP/RAMP1 signaling drives endometriosis-associated pain and lesion growth in mice. Sci Transl Med. 2024 Nov 6;16(772):eadk8230. doi: 10.1126/scitranslmed.adk8230. Epub 2024 Nov 6.

    PubMed 39504351

  • Pasquini B, Seravalli V, Vannuccini S, La Torre F, Geppetti P, Iannone L, Benemei S, Petraglia F. Endometriosis and the diagnosis of different forms of migraine: an association with dysmenorrhoea. Reprod Biomed Online. 2023 Jul;47(1):71-76. doi: 10.1016/j.rbmo.2023.03.020. Epub 2023 Apr 7.

    PubMed 37202318

  • Karp BI, Sinaii N, Nieman LK, Silberstein SD, Stratton P. Migraine in women with chronic pelvic pain with and without endometriosis. Fertil Steril. 2011 Mar 1;95(3):895-9. doi: 10.1016/j.fertnstert.2010.11.037. Epub 2010 Dec 10.

    PubMed 21145540

  • Raffaelli B, Overeem LH, Mecklenburg J, Hofacker MD, Knoth H, Nowak CP, Neeb L, Ebert AD, Sehouli J, Mechsner S, Reuter U. Plasma calcitonin gene-related peptide (CGRP) in migraine and endometriosis during the menstrual cycle. Ann Clin Transl Neurol. 2021 Jun;8(6):1251-1259. doi: 10.1002/acn3.51360. Epub 2021 May 2.

    PubMed 33934575

  • Yang MH, Wang PH, Wang SJ, Sun WZ, Oyang YJ, Fuh JL. Women with endometriosis are more likely to suffer from migraines: a population-based study. PLoS One. 2012;7(3):e33941. doi: 10.1371/journal.pone.0033941. Epub 2012 Mar 19.

    PubMed 22442736

  • Tietjen GE, Conway A, Utley C, Gunning WT, Herial NA. Migraine is associated with menorrhagia and endometriosis. Headache. 2006 Mar;46(3):422-8. doi: 10.1111/j.1526-4610.2006.00290.x.

    PubMed 16618258

  • Lee GJ, Hode V, Georgieva T, Rau J, Dodick DW, Schwedt TJ, Neugebauer V, Porreca F, Navratilova E. Prolactin-induced sensitization of trigeminal nociceptors promotes migraine co-morbidity in endometriosis. Cephalalgia. 2025 Jan;45(1):3331024241313378. doi: 10.1177/03331024241313378.

    PubMed 39814523

  • Wu Y, Wang H, Chen S, Lin Y, Xie X, Zhong G, Zhang Q. Migraine Is More Prevalent in Advanced-Stage Endometriosis, Especially When Co-Occuring with Adenomoysis. Front Endocrinol (Lausanne). 2022 Jan 24;12:814474. doi: 10.3389/fendo.2021.814474. eCollection 2021.

    PubMed 35140688

  • Tietjen GE, Bushnell CD, Herial NA, Utley C, White L, Hafeez F. Endometriosis is associated with prevalence of comorbid conditions in migraine. Headache. 2007 Jul-Aug;47(7):1069-78. doi: 10.1111/j.1526-4610.2007.00784.x.

    PubMed 17635599

  • Aegidius KL, Zwart JA, Hagen K, Dyb G, Holmen TL, Stovner LJ. Increased headache prevalence in female adolescents and adult women with early menarche. The Head-HUNT Studies. Eur J Neurol. 2011 Feb;18(2):321-328. doi: 10.1111/j.1468-1331.2010.03143.x.

    PubMed 20636369

  • Miller JA, Missmer SA, Vitonis AF, Sarda V, Laufer MR, DiVasta AD. Prevalence of migraines in adolescents with endometriosis. Fertil Steril. 2018 Apr;109(4):685-690. doi: 10.1016/j.fertnstert.2017.12.016. Epub 2018 Mar 28.

    PubMed 29605402

  • Selntigia A, Exacoustos C, Ortoleva C, Russo C, Monaco G, Martire FG, Rizzo G, Della-Morte D, Mercuri NB, Albanese M. Correlation between endometriosis and migraine features: Results from a prospective case-control study. Cephalalgia. 2024 Mar;44(3):3331024241235210. doi: 10.1177/03331024241235210.

    PubMed 38436302

  • Burch RC, Buse DC, Lipton RB. Migraine: Epidemiology, Burden, and Comorbidity. Neurol Clin. 2019 Nov;37(4):631-649. doi: 10.1016/j.ncl.2019.06.001. Epub 2019 Aug 27.

    PubMed 31563224

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine and Endometriosis, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patricia Pozo-Rosich, Professor (+34 934 89 30 00, patricia.pozo@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07519343, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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