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

Sponsor
AbbVie
Study ID
NCT01817530
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 51 Years
Healthy Volunteers
Not accepted

Interventions

  • Elagolix placebo — OTHER
    oral coated tablet
  • Elagolix — DRUG
    oral coated tablet
  • 0.5 mg estradiol / 0.1 mg norethindrone acetate — DRUG
    oral hard capsule
  • 1 mg estradiol / 0.5 mg norethindrone acetate — DRUG
    oral hard capsule
  • E2/NETA placebo — DRUG
    oral hard capsule

Study Details

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.

Key Dates

Start date
Apr 8, 2013
Status verified
Jun 2020
Primary completion
Jun 30, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
571 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Cohort 1: Placebo
    Placebo for elagolix and placebo for E2/NETA twice daily (BID)
  • Experimental: Cohort 1: Elagolix 300 mg BID
    Elagolix 300 mg BID alone
  • Experimental: Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD
    Elagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD)
  • Experimental: Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD
    Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD
  • Placebo Comparator: Cohort 2: Placebo
    Placebo for elagolix and E2/NETA QD
  • Experimental: Cohort 2: Elagolix 600 mg QD
    Elagolix 600 mg QD alone
  • Experimental: Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD
    Elagolix 600 mg QD plus LD E2/NETA QD
  • Experimental: Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD
    Elagolix 600 mg QD plus SD E2/NETA QD

Primary Outcome Measure

Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month [ Time Frame: Baseline, Final Month (last 28 days of treatment) ]

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