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Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

NCT01441635 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2021-07-13

Study results available
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Summary

The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.

Conditions

  • Heavy Uterine Bleeding
  • Uterine Fibroids

Interventions

DRUG

Elagolix

Elagolix tablets

DRUG

Placebo

Matching placebo tablets

DRUG

Estradiol/Norethindrone acetate (E2/NETA)

A continuous once-daily oral tablet containing estrogen and progestin; the low-dose strength contains estradiol 0.5 mg and norethindrone acetate 0.1 mg.

DRUG

Estradiol

1.0 mg micronized estradiol tablets administered once a day

DRUG

Progesterone

Progesterone 200 mg administered during the last 12 days of the 28-day menstrual cycle

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-08
Primary Completion
2013-11-30
Completion
2014-05-17
FDA Drug
Yes

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Drugs

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 NCT01441635 on ClinicalTrials.gov