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Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

NCT03271489 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2025-07-22

Study results available
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Summary

This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.

Conditions

  • Heavy Menstrual Bleeding
  • Uterine Fibroids

Interventions

DRUG

Elagolix

Film-coated 300 mg tablets

DRUG

Estradiol /norethindrone acetate (E2/NETA)

Estradiol 1 mg/norethindrone acetate 0.5 mg capsules

OTHER

E2/NETA Placebo

Placebo capsules

OTHER

Elagolix Placebo

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
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-13
Primary Completion
2024-06-28
Completion
2024-06-28
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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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 NCT03271489 on ClinicalTrials.gov