A Phase 2 interventional study of Rimegepant 75 MG and Placebo in Endometriosis and Endometriosis-related Pain, sponsored by Mayo Clinic. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria
Participants randomized to this arm will receive Rimegepant 75 mg administered orally every other day for 12 weeks.
Drug: Rimegepant 75 MG
Participants randomized to this arm will receive matching placebo capsules administered orally every other day for 12 weeks.
Drug: Placebo
Rimegepant 75 mg oral capsule administered every other day for 12 weeks
Matching placebo oral capsule administered every other day for 12 weeks.
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.
Time frame: 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.
Time frame: Baseline to Weeks 9-12
Proportion of Responders
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.
Time frame: Baseline to Weeks 9-12
Reduction in Rescue Analgesic Use
The change in the mean frequency (days per week) of rescue analgesic administration, reported as morphine milligram equivalents (MME)
Time frame: Baseline to Weeks 9-12
Reduction in Monthly Migraine Frequency
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.
Time frame: Baseline to Weeks 9-12
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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