Clinical trial NCT06785129: Endometriosis and Migraine
Official title: Mechanisms Underlying Endometriosis and Migraine Comorbidity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Endometriosis
Keywords: Migraine
endometriosis
hormones
pain
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: participants with migraine OR with endometriosis OR with migraine and endometriosis OR with no chronic pain condition

Brief summary: This study aims to determine differences in experimental pain and sex hormone levels between patients with migraine, patients with endometriosis, patients with migraine and endometriosis, and healthy controls. Participants will complete surveys, experimental pain paradigms and collection of samples for hormone analyses.

Detailed description: Participants will be recruited via the pain, headache and Ob/Gyn clinics, via Volunteers for Health, via other studies in the lab, study staff, and via EPIC. When potential participants are inquiring about studies with the Pain the Lifespan Lab, the study team will describe this study among the options. Potential participants might be identified via EPIC records using age, sex, diagnoses, notes, problem list, medications, and phone number.

A research staff member will contact a potential participant and provide a description of the project. Potentially eligible participants will be invited to participate in the study, which will be conducted at Washington University School of Medicine. Participants will also be provided with a written summary of or the consent form for the study. The consent will be signed electronically using Docusign e-consent process either remotely during a phone call or a video call (WUSTL Zoom) with a study staff or in person.

After confirming the inclusion criteria and signing the consent form, participants will complete a 2.5-3 hour study visit of psychophysical assessments of thermal and pressure stimuli. Participants will also complete various questionnaires including demographic, social, health, behavioral, and psychological questionnaires. For adolescents, a parent/legal guardian will be asked to assist in completing some of the health-related surveys (i.e., physical developmental survey, health survey, migraine history survey). Obstetric, gynecologic, fertility, surgical history, medications, and pain will be abstracted from the medical record and/or via health history interview. Blood, urine, and/or saliva samples will be collected for hormonal, immune, and/or genetic testing. Additional samples will be stored in a biobank for future hormonal, immune and/or genetic analyses. Participants will then complete follow-up surveys once monthly for up to 1 year after the study visit which will assess changes to their pain symptoms and treatments. All study procedures are optional, and participants can stop or not complete tests if they want.

Eligibility criteria: Inclusion Criteria:

1. Patients with diagnosed endometriosis, migraine, or both endometriosis and migraine
2. Healthy control subjects with no history of chronic pain
3. Age 12-45
4. Assigned female sex at birth

Exclusion Criteria:

1. Pregnancy or breastfeeding
2. Presence of prolactinoma
3. Presence of psychiatric, neurological, endocrinological and/or developmental conditions and taking medications for these conditions
4. Current use of dopamine agonist or SSRI medications
5. For patients aged 12-17 not having a parent/legal guardian willing to sign the consent and answer surveys about their child's health

Primary outcomes:
measure: Conditioned pain modulation (CPM) response
timeFrame: Baseline
measure: Sex Hormones
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Hadas Nahman-Averbuch, PhD
role: PRINCIPAL_INVESTIGATOR
References: