Endometriosis, Endometriosis-related Pain
Conditions
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.
Interventions
DRUGRimegepant 75 MG
Rimegepant 75 mg oral capsule administered every other day for 12 weeks
DRUGPlacebo
Matching placebo oral capsule administered every other day for 12 weeks.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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 Any subject with a positive urine hCG test at screening or during the trial will be excluded or immediately withdrawn.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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Non-Menstrual Pelvic Pain (NMPP) | Baseline to Weeks 9-12 | 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. |
| Change in Dysmenorrhea (Menstrual Pain) | Baseline to Weeks 9-12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Responders | Baseline to Weeks 9-12 | The percentage of participants achieving clinically meaningful pain reduction, defined as a ≥40% reduction in the mean daily EDPI score for non-menstrual pelvic pain (NMPP) and a ≥60% reduction in the mean daily EDPI score for dysmenorrhea. |
| Reduction in Rescue Analgesic Use | Baseline to Weeks 9-12 | The change in the mean frequency (days per week) of rescue analgesic administration, reported as morphine milligram equivalents (MME) |
| Reduction in Monthly Migraine Frequency | Baseline to Weeks 9-12 | In the pre-specified subgroup of participants with comorbid migraine, the change from baseline in the number of monthly migraine days (MMD) as recorded in a daily headache diary. |
Countries
United States
Contacts
CONTACTClinical Studies Unit
PRINCIPAL_INVESTIGATORYohannes Woldeamanuel, MD
Mayo Clinic
Outcome results
None listed