Clinical Trials

Study Title

A Phase 3b Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Combination with Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women

Purpose

1) To assess the safety and efficacy of elagolix 300 mg BID in combination with E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg QD) compared to placebo at 1 year in reducing heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

2) to characterize the impact of elagolix 300 mg BID with E2/NETA on bone mineral density (BMD) in women with heavy menstrual bleeding associated with uterine fibroids after up to 2 years of treatment.

Eligibility

Premenopausal female 18 to 48 years of age

 Diagnosis of uterine fibroids

 Can not have:

Menstrual cycles that are > 38 days in length for the past 3 months

Endometrial ablation within 1 year

Active pelvic inflammatory disease (PID)

History of Osteoporosis or other metabolic bone disease

Study Process

Stipend:  $50.00 for most visits; $50 per procedure The total duration for this study is up to 53 months.  The study consists of 4 periods:

Washout Period – up to 10 months prior to Screening (only applicable if subject is taking exclusionary medication at the time of consent; duration of washout depends on the type of exclusionary medication being taken)

Screening Period – approximately 2.5 to 5 Months prior to first dose of study drug       

Treatment Period – up to 24-month treatment duration. ·        Post-Treatment Follow-Up Period – up to 12 month duration following the last dose of the study drug. Subjects are expected to enter

Post-Treatment Follow-Up after completing TreatmentMonth 24 or if a subject prematurely discontinues from the Treatment Period at the time of or after Treatment Month 6.