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

PHASE2CompletedINTERVENTIONAL

Enrollment

571

Participants

Timeline

Start Date

April 8, 2013

Primary Completion Date

June 30, 2015

Study Completion Date

December 31, 2015

Conditions

Heavy Uterine BleedingUterine 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