Conditions: Heavy Uterine Bleeding Uterine Fibroids
Keywords: Uterine Fibroids Leiomyomata Elagolix Menorrhagia Elagolix sodium Heavy Uterine Bleeding ABT-620
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 571
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Placebo for elagolix and placebo for E2/NETA twice daily (BID) arm 2: Elagolix 300 mg BID alone arm 3: Elagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD) arm 4: Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD arm 5: Placebo for elagolix and E2/NETA QD arm 6: Elagolix 600 mg QD alone arm 7: Elagolix 600 mg QD plus LD E2/NETA QD arm 8: Elagolix 600 mg QD plus SD E2/NETA QD

Interventions: intervention 1: Elagolix placebo intervention 2: Elagolix intervention 3: 0.5 mg estradiol / 0.1 mg norethindrone acetate intervention 4: 1 mg estradiol / 0.5 mg norethindrone acetate intervention 5: E2/NETA placebo
Intervention descriptions: intervention 1: oral coated tablet intervention 2: oral coated tablet intervention 3: oral hard capsule intervention 4: oral hard capsule intervention 5: oral hard capsule

Protocol document: