MedTrace Logo

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

NCT03654326 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2024-11-04

Study results available
· View outcomes & findings →

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.

Conditions

  • Endometriosis-related Pain

Interventions

DRUG

Gefapixant

Gefapixant tablet 45 mg taken orally

DRUG

Placebo

Placebo matching gefapixant tablet taken orally

DRUG

Naproxen

Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-11
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Chile
  • New Zealand
  • Poland
  • Puerto Rico
  • Russia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03654326 on ClinicalTrials.gov