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
Tagged with
Interventions
-
Rimegepant 75 MG
DRUG
Rimegepant 75 mg oral capsule administered every other day for 12 weeks
-
Placebo
DRUG
Matching placebo oral capsule administered every other day for 12 weeks.
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 Any subject with a positive urine hCG test at screening or during the trial will be excluded or immediately withdrawn.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
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine