Can a migraine drug ease endometriosis pain?
NCT ID NCT07795125
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This phase II trial tests whether rimegepant, a drug used for migraines, can reduce pelvic pain in women with endometriosis. The study enrolls 132 women aged 18 to 45 with surgically confirmed endometriosis and moderate-to-severe pain. Participants take either rimegepant or a placebo every other day for 12 weeks. Researchers measure changes in non-menstrual pelvic pain and menstrual pain using a daily pain scale.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rimegepant 75 mg oral capsule taken every other day for 12 weeks
- What this could lead to
- If it works, rimegepant could offer a new, non-hormonal option for managing endometriosis-related pain.
- What could go wrong
- This is a phase II trial with a modest number of participants, so results may not hold up in larger studies. Rimegepant is not yet proven for this condition, and its effectiveness and safety in endometriosis are uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 132 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * Consent: Female subjects, aged 18 to 45 years inclusive, who are able to provide written informed consent. * Surgical Confirmation: Histologically confirmed diagnosis of endometriosis via surgical pathology performed within the 3 to 6 months prior to screening. * Pain Severity: Presence of moderate-to-severe endometriosis-associated pain, defined as an EDPI score of 2 or higher during the screening period. * Contraceptive Requirement: Current use of an effective method of contraception (including hormonal contraceptives, intra-uterine devices, or sterilization). Subjects must commit to continuing the same contraceptive method throughout the 12-week study to avoid confounding pain levels and ensure safety. * Pregnancy Testing: Willingness to undergo urine at in person visits and urine hCG at home pregnancy testing at screening and every 4 weeks (Weeks 0, 4, 8, and 12) during the trial. Exclusion Criteria * Pregnancy and Lactation: Pregnant or breastfeeding women. Any subject with a positive urine hCG test at screening or during the trial will be excluded or immediately withdrawn. * Menopausal Status: Women who are menopausal, whether through natural onset or surgical intervention. * Cardiovascular and Metabolic Disease: History of cardiovascular disease, stroke, uncontrolled hypertension, or diabetes. * Organ Impairment: Presence of severe kidney or liver disease (specifically ALT/AST \>2x ULN). * Medication and Allergy: Known hypersensitivity or allergy to rimegepant or other CGRP-targeting medications. * Lack of Contraception: Women not currently using an effective method of contraception, including those not on medication or not sterilized. * Prior Clinical Trial Exposure: Participation in another investigational drug or device trial within 30 days prior to screening. * Compliance: Inability to comply with study procedures, including the daily electronic EDPI diary and mandatory in-person clinic visits.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic
Phoenix, Arizona, 85054, United States
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