NCT01441635View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL

Enrollment

271

Participants

Timeline

Start Date

September 8, 2011

Primary Completion Date

November 30, 2013

Study Completion Date

May 17, 2014

Conditions

Heavy Uterine BleedingUterine 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

All Listed Sponsors

lead

AbbVie (prior sponsor, Abbott)

INDUSTRY

NCT01441635 - Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids | Biotech Hunter | Biotech Hunter