EndometriosisPhase 2NCT07795125
Rimegepant For Endometriosis Pain
A Phase 2 study testing Rimegepant 75 MG in people with Endometriosis and Endometriosis-related Pain, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Endometriosis-related Pain
- What is being tested?
- Rimegepant 75 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 30 Sep 2031
- Phase
- Phase 2
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 Any subject with a positive urine hCG test at screening or during the trial will be excluded or immediately withdrawn.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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Safety And Efficacy Of Rimegepant For Endometriosis-Associated Pain
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.
- Conditions
- Endometriosis, Endometriosis-related Pain
- Being tested
- Rimegepant 75 MG, Placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimegepant 75 MGDrug
Rimegepant 75 mg oral capsule administered every other day for 12 weeks
PlaceboDrug
Matching placebo oral capsule administered every other day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant | Experimental | Participants randomized to this arm will receive Rimegepant 75 mg administered orally every other day for 12 weeks. Receives: Drug: Rimegepant 75 MG |
| Placebo | Placebo comparator | Participants randomized to this arm will receive matching placebo capsules administered orally every other day for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Weeks 9-12
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.
Measured: Baseline to Weeks 9-12
Secondary outcomes (3)
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.
Measured: Baseline to Weeks 9-12
Reduction in Rescue Analgesic Use
The change in the mean frequency (days per week) of rescue analgesic administration, reported as morphine milligram equivalents (MME)
Measured: Baseline to Weeks 9-12
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.
Measured: Baseline to Weeks 9-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Mar 2031 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yohannes Woubishet Woldeamanuel, Mayo Clinic
- Investigators
- Yohannes Woldeamanuel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795125
- Sponsor's protocol ID
- 26-001411
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Safety And Efficacy Of Rimegepant For Endometriosis-Associated Pain
- ClinicalTrials.gov ID
- NCT07795125
- Acronym / sponsor ID
- 26-001411
- Conditions
- Endometriosis, Endometriosis-related Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Mar 2031 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rimegepant | Experimental | Drug: Rimegepant 75 MGParticipants randomized to this arm will receive Rimegepant 75 mg administered orally every other day for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to this arm will receive matching placebo capsules administered orally every other day for 12 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rimegepant 75 MGRimegepant 75 mg oral capsule administered every other day for 12 weeks | Drug | Rimegepant |
| PlaceboMatching placebo oral capsule administered every other day for 12 weeks. | Drug | Placebo |
Primary outcome
Change in Non-Menstrual Pelvic Pain (NMPP)
Time frame: Baseline to Weeks 9-12
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.
Change in Dysmenorrhea (Menstrual Pain)
Time frame: Baseline to Weeks 9-12
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.
3 secondary outcomes
Proportion of Responders
Time frame: Baseline to Weeks 9-12
Reduction in Rescue Analgesic Use
Time frame: Baseline to Weeks 9-12
Reduction in Monthly Migraine Frequency
Time frame: Baseline to Weeks 9-12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yohannes Woldeamanuel, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rimegepant 75 MG in people with Endometriosis and Endometriosis-related Pain, run by Mayo Clinic at 1 site in United States.
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 5 inclusion and 8 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 31 Aug 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Clinical Studies Unit (480-342-2906, Woldeamanuel.YohannesWoubishet@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Non-Menstrual Pelvic Pain (NMPP) (time frame: Baseline to Weeks 9-12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.