Tests rimegepant for pain caused by endometriosis
Compares rimegepant with a placebo in women with endometriosis-related pain.
Plain-language title generated from the registry record
Registry title: Rimegepant For Endometriosis Pain
Key facts
- Where
- Phoenix, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT07795125, who can take part
Where in United States
- Mayo ClinicPhoenix, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mayo Clinic
- Trial code
- NCT07795125
- Record updated
- 31 August 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: Menopausal Status: Women who are menopausal, whether through natural onset or surgical intervention; 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; Cardiovascular and Metabolic Disease: History of cardiovascular disease, stroke, uncontrolled hypertension, or diabetes; Medication and Allergy: Known hypersensitivity or allergy to rimegepant or other CGRP-targeting medications; Organ Impairment: Presence of severe kidney or liver disease (specifically ALT/AST >2x ULN); 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; Compliance: Inability to comply with study procedures, including the daily electronic EDPI diary and mandatory in-person clinic visits.