A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Safety And Efficacy Of Rimegepant For Endometriosis-Associated Pain

Mayo Clinic

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.

Eligibility

Age range: 18–45 years
Sex: Female
Healthy volunteers: No

Detailed criteria

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…

Interventions

Drug
Rimegepant 75 MG
Rimegepant 75 mg oral capsule administered every other day for 12 weeks
Drug
Placebo
Matching placebo oral capsule administered every other day for 12 weeks.

Location

Mayo Clinic
Phoenix, Arizona

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Safety And Efficacy Of Rimegepant For Endometriosis-Associated Pain

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions