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

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01441635
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Elagolix — DRUG
    Elagolix tablets
  • Placebo — DRUG
    Matching placebo tablets
  • Estradiol/Norethindrone acetate (E2/NETA) — DRUG
    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.
  • Estradiol — DRUG
    1.0 mg micronized estradiol tablets administered once a day
  • Progesterone — DRUG
    Progesterone 200 mg administered during the last 12 days of the 28-day menstrual cycle

Study Details

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.

Key Dates

Start date
Sep 8, 2011
Status verified
Jul 2021
Primary completion
Nov 30, 2013
Completion
May 17, 2014

Study Design

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

Arms

  • Experimental: Cohort 4 Elagolix 400 mg QD
    Participants received elagolix 400 mg once a day (QD) for 3 months.
  • Experimental: Cohort 4 Elagolix 100 mg BID
    Participants received elagolix 100 mg twice a day (BID) for 3 months.
  • Placebo Comparator: Cohort 4 Placebo
    Participants received placebo to elagolix BID for 3 months.
  • Experimental: Cohort 1 Elagolix 200 mg BID
    Participants received elagolix 200 mg twice a day for 3 months.
  • Placebo Comparator: Cohort 1 Placebo
    Participants received placebo to elagolix twice a day for 3 months.
  • Placebo Comparator: Cohort 3 Elagolix 200 mg BID + LD E2/NETA
    Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
  • Experimental: Cohort 5 Elagolix 600 mg QD
    Participants received elagolix 600 mg once a day for 3 months.
  • Experimental: Cohort 2 Elagolix 300 mg BID
    Participants received elagolix 300 mg twice a day for 3 months.
  • Experimental: Cohort 2 Placebo
    Participants received placebo to elagolix BID for 3 months.
  • Experimental: Cohort 6 Elagolix 300 mg BID + CEP
    Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.

Primary Outcome Measure

Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) [ Time Frame: Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90) ]

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