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A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

NCT01931670 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 815

Last updated 2018-09-07

Study results available
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Summary

A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.

Conditions

  • Endometriosis

Interventions

OTHER

placebo

DRUG

Elagolix

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-09
Primary Completion
2016-01-06
Completion
2016-12-19
FDA Drug
Yes

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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 NCT01931670 on ClinicalTrials.gov