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Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis

NCT00797225 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2018-09-10

Study results available
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Summary

This study is designed to evaluate the safety and beneficial effects of elagolix (NBI-56418) compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month period followed by an additional three months of treatment on elagolix.

Conditions

  • Endometriosis

Interventions

DRUG

Leuprorelin Acetate Depot

Leuprorelin acetate depot injection 3.75 mg administered as an intramuscular injection

DRUG

Elagolix

Elagolix tablets administered orally

DRUG

Placebo to Elagolix

Placebo tablet administered orally

DRUG

Placebo to Leuprorelin Acetate

Saline solution administered as an intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-26
Primary Completion
2010-02-24
Completion
2010-02-24
FDA Drug
Yes

More Related Trials

Entities

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 NCT00797225 on ClinicalTrials.gov