Rimegepant For Endometriosis Pain

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 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 Any subject with a positive urine hCG test at screening or during the trial will be excluded or immediately withdrawn.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.