ClinicalTrials.gg
Not yet recruitingNCT07795125Updated Aug 31, 2026

Rimegepant For Endometriosis Pain

A Phase 2 interventional study of Rimegepant 75 MG and Placebo in Endometriosis and Endometriosis-related Pain, sponsored by Mayo Clinic. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 168 studies in Endometriosis with a site in United States — 37 open to participants now, 47 under way, 5 of them phase 3. Endometriosis · United States.

Planned enrollment
29th of 130
132 · median 60
Started
2026
with 13 others
Phase 2
39 of 168
1 open now
Primary completion
2031-03
later than 45 of 46 live
Registered
166th of 168
by date
Lead sponsor
4 of 168
Mayo Clinic

Among the 168 studies in Endometriosis with a site in United States, this one is the 29th largest by planned enrollment of the 130 interventional ones, is one of 14 that started in 2026, is one of 39 in phase 2, reaches primary completion later than 45 of the 46 other live ones, and was the 166th registered.

By phase

168 studies; the count open now beside each. This study's row is marked.

Phase 2this study39 · 1 open
No phase38 · 11 open
Observational38 · 14 open
Phase 321 · 3 open
Phase 414 · 5 open
Phase 112 · 2 open
Phase 1/25 · 1 open
Phase 2/31 · 0 open

By the year they started

First in 1998; this study’s year is marked. 14 started in 2026.

Size and results

Median enrollment 60 across the 130 interventional studies, 187 across the 38 observational. Of the 102 that completed or were terminated, 50 (49%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 168 studies in Endometriosis with a site in United States, or all of them as a file.
02

Study summary

The purpose of this study is to evaluate the efficacy of rimegepant 75 mg versus placebo in reducing endometriosis-associated pain (EAP) in women with moderate-to-severe pain and histologically confirmed endometriosis.

03

Conditions studied

  • Endometriosis
  • Endometriosis-related Pain

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04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Consent: Female subjects, aged 18 to 45 years inclusive, who are able to provide written .
  • Surgical Confirmation: 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.
  • 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

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 /AST >2x ).
  • Medication and Allergy: Known or allergy to rimegepant or other CGRP-targeting medications.
  • Lack of : Women not currently using an effective method of contraception, including those not on medication or not sterilized.
  • Prior Clinical Trial Exposure: Participation in another 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
132 participants (estimated)

Study arms

  • Experimental
    Rimegepant

    Participants randomized to this arm will receive Rimegepant 75 mg administered orally every other day for 12 weeks.

    Drug: Rimegepant 75 MG

  • Placebo comparator
    Placebo

    Participants randomized to this arm will receive matching placebo capsules administered orally every other day for 12 weeks.

    Drug: Placebo

Interventions

  • Rimegepant 75 mg oral capsule administered every other day for 12 weeks

  • DrugPlacebo

    Matching placebo oral capsule administered every other day for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Change in Non-Menstrual Pelvic Pain (NMPP)

    Non-menstrual pelvic pain will be assessed using the Endometriosis Daily Pain Impact (EDPI) score. The EDPI is a participant-reported numeric rating scale used to assess endometriosis-associated pain, with scores ranging from 0 to 10; higher scores indicate greater pain intensity and/or impact. The baseline value will be calculated from the pre-treatment baseline assessment period, and the post-baseline value will be calculated as the mean daily score during Weeks 9 through 12.

    Time frame: Baseline to Weeks 9-12

  2. Change in Dysmenorrhea (Menstrual Pain)

    Dysmenorrhea (Menstrual Pain) will be assessed using the Endometriosis Daily Pain Impact (EDPI) score for dysmenorrhea. The EDPI (dysmenorrhea) is a participant-reported numeric rating scale that measures the severity of painful uterine cramping and pelvic pain specifically associated with the menstrual cycle. Scores range from 0 to 10; higher scores indicate greater pain intensity and/or impact. The baseline value will be calculated from the pre-treatment baseline assessment period, and the post-baseline value will be calculated as the mean daily score during Weeks 9 through 12.

    Time frame: Baseline to Weeks 9-12

Secondary outcomes

  1. Proportion of Responders

    The percentage of participants achieving clinically meaningful pain reduction, defined as a ≥40% reduction in the mean daily EDPI score for non-menstrual pelvic pain (NMPP) and a ≥60% reduction in the mean daily EDPI score for dysmenorrhea.

    Time frame: Baseline to Weeks 9-12

  2. Reduction in Rescue Analgesic Use

    The change in the mean frequency (days per week) of rescue analgesic administration, reported as morphine milligram equivalents (MME)

    Time frame: Baseline to Weeks 9-12

  3. Reduction in Monthly Migraine Frequency

    In the pre-specified subgroup of participants with comorbid migraine, the change from baseline in the number of monthly migraine days (MMD) as recorded in a daily headache diary.

    Time frame: Baseline to Weeks 9-12

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Mar 2031, 54 months later.

Of 44 phase 2 interventional studies under Endometriosis, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 37. This study's planned 54 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Aug 31, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
Mar 30, 2031
CompletionEst.
Sep 30, 2031
Last update
Aug 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07795125
Lead sponsor
Mayo Clinic
Responsible party
Yohannes Woubishet Woldeamanuel (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Aug 31, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Mar 30, 2031 (estimated)
Completion
Sep 30, 2031 (estimated)
Last update
Aug 31, 2026

Study contacts

Clinical Studies Unit
Contact
Woldeamanuel.YohannesWoubishet@mayo.edu
480-342-2906
Yohannes Woldeamanuel, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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