NCT07795125Not yet recruitingPhase 2
Rimegepant For Endometriosis Pain
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Safety And Efficacy Of Rimegepant For Endometriosis-Associated Pain
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 26 Aug 2026
- Start date
- Sept 2026
- Primary completion date
- Mar 2031
- Lead sponsor
- Mayo Clinic
- Diseases
- Endometriosis
- NCT number
- NCT07795125
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 132
- From Sept 2026 to the primary completion date, Mar 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- Organ Impairment: Presence of severe kidney or liver disease (specifically ALT/AST \>2x ULN).
Other
- 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 Any subject with a positive urine hCG test at screening or during the trial will be excluded or immediately withdrawn.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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.