Health TrialsbyHealthPanel

Rimegepant For Endometriosis Pain

ConditionsEndometriosisEndometriosis-related Pain
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 Any subject with a positive urine hCG test at screening or during the trial will be excluded or immediately withdrawn.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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: RimegepantExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: