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Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

NCT02654054 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2020-06-29

Study results available
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Summary

This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Conditions

  • Uterine Fibroids
  • Heavy Menstrual Bleeding

Interventions

DRUG

Elagolix

Film-coated tablets

DRUG

Placebo for Estradiol/Norethindrone Acetate

Placebo capsules

DRUG

Estradiol/Norethindrone Acetate

Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.

DRUG

Placebo for Elagolix

Film-coated placebo tablets

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-12-22
Primary Completion
2018-01-18
Completion
2018-12-12
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

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 NCT02654054 on ClinicalTrials.gov