Rimegepant For Endometriosis Pain

NCT07795125 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 26-001411
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis; Endometriosis-related Pain

Outcome Measures

Primary Outcomes (2)

• Change in Non-Menstrual Pelvic Pain (NMPP)

  Non-menstrual pelvic pain will be assessed using the Endometriosis Daily Pain Impact (EDPI) score. The EDPI is a participant-reported numeric rating scale used to assess endometriosis-associated pain, with scores ranging from 0 to 10; higher scores indicate greater pain intensity and/or impact. The baseline value will be calculated from the pre-treatment baseline assessment period, and the post-baseline value will be calculated as the mean daily score during Weeks 9 through 12.

  Baseline to Weeks 9-12

• Change in Dysmenorrhea (Menstrual Pain)

  Dysmenorrhea (Menstrual Pain) will be assessed using the Endometriosis Daily Pain Impact (EDPI) score for dysmenorrhea. The EDPI (dysmenorrhea) is a participant-reported numeric rating scale that measures the severity of painful uterine cramping and pelvic pain specifically associated with the menstrual cycle. Scores range from 0 to 10; higher scores indicate greater pain intensity and/or impact. The baseline value will be calculated from the pre-treatment baseline assessment period, and the post-baseline value will be calculated as the mean daily score during Weeks 9 through 12.

  Baseline to Weeks 9-12

Secondary Outcomes (3)

• Proportion of Responders

  Baseline to Weeks 9-12

• Reduction in Rescue Analgesic Use

  Baseline to Weeks 9-12

• Reduction in Monthly Migraine Frequency

  Baseline to Weeks 9-12

Study Arms (2)

Rimegepant

EXPERIMENTAL

Participants randomized to this arm will receive Rimegepant 75 mg administered orally every other day for 12 weeks.

Drug: Rimegepant 75 MG

Placebo

PLACEBO COMPARATOR

Participants randomized to this arm will receive matching placebo capsules administered orally every other day for 12 weeks.

Drug: Placebo

Interventions

Rimegepant 75 MG DRUG

Rimegepant 75 mg oral capsule administered every other day for 12 weeks

Rimegepant

Placebo DRUG

Matching placebo oral capsule administered every other day for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Conditions

Endometriosis

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Yohannes Woldeamanuel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Studies Unit

CONTACT

480-342-2906; Woldeamanuel.YohannesWoubishet@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): March 30, 2031
• Study Completion (Estimated): September 30, 2031
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)