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Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

NCT01817530 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 571

Last updated 2020-07-21

Study results available
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Summary

This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.

Conditions

  • Heavy Uterine Bleeding
  • Uterine Fibroids

Interventions

OTHER

Elagolix placebo

oral coated tablet

DRUG

Elagolix

oral coated tablet

DRUG

0.5 mg estradiol / 0.1 mg norethindrone acetate

oral hard capsule

DRUG

1 mg estradiol / 0.5 mg norethindrone acetate

oral hard capsule

DRUG

E2/NETA placebo

oral hard capsule

Sponsors & Collaborators

Principal Investigators

  • Charlotte Owens, MD · 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
2013-04-08
Primary Completion
2015-06-30
Completion
2015-12-31

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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 NCT01817530 on ClinicalTrials.gov