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  • Development of a Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test to Detect Intra-Amniotic Infection and Predict Preterm Birth in Women Presenting With Preterm Labor and Intact Amniotic Membranes

    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

  • A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Estradiol/Norethindrone Acetate in Subjects with Moderate to Severe Endometriosis-Associated Pain

    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.

  • 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

    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.

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