drugset / Trial / NCT03654326

A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)

NCT03654326

Phase 2 Completed 187 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in premenopausal female participants with moderate to severe endometriosis-related pain. The primary hypothesis: gefapixant is superior to placebo in reducing the average daily pelvic pain score (cyclic and non-cyclic, combined) during Treatment Cycle 2.

Timeline

Start
2018-09-11
Primary completion
2020-06-30
Completion
2020-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Gefapixant Small molecule 45 mg Oral
Background Naproxen Small molecule 275 mg Oral

Indications