Rimegepant For Endometriosis Pain

NCT07795125 · ctgov not_yet_recruiting phase phase-2
Enrollment
132
Start
2026-09-30
Completion
2031-09-30
Last updated
2026-08-31
Has results
False
Countries
United States

Conditions

EndometriosisEndometriosis-related Pain

Tagged with

endometriosis

Interventions

Eligibility criteria
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 Any subject with a positive urine hCG test at screening or during the trial will be excluded or immediately withdrawn.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.
License: public-domain-us · commercial use OK · attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine

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