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Efficacy and Safety Study of Elagolix in Women With Endometriosis

NCT00973973 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2018-09-26

Study results available
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Summary

The purpose of this study is to evaluate elagolix (NBI-56418) compared to placebo for its effects on endometriosis related pelvic pain and its safety.

Conditions

  • Endometriosis, Pain

Interventions

DRUG

Placebo

Matching placebo tablets taken orally once a day

DRUG

Elagolix

Immediate release (IR) tablets taken orally once a day

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
2009-10-12
Primary Completion
2010-09-22
Completion
2010-09-22
FDA Drug
Yes

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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 NCT00973973 on ClinicalTrials.gov