To collect clinical specimens and corresponding clinical data to assess the performance of a rapid amniotic fluid test (AF) and a non-invasive vaginal fluid (VF) test for detection of intra-amniotic infection and prediction of preterm birth
1) assess the safety and efficacy of elagolix 200 mg administered twice daily (BID) in combination with low dose Estradiol/Norethindrone acetate (E2/NETA) QD and elagolix 200 mg BID in combination with standard dose Estradiol/Norethindrone acetate (E2/NETA) QD compared to placebo at 6 months
2) to assess the effect of elagolix 200 mg BID in combination with low dose E2/NETA QD and elagolix 200 mg BID in combination with standard dose E2/NETA QD on bone mineral density (BMD) compared to placebo at 6 months and compared to elagolix 200 mg BID alone at 12 months in premenopausal women with moderate to severe endometriosis-associated pain.
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.