Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Heavy Uterine Bleeding, Uterine Fibroids
About this trial
This is an interventional treatment trial for Heavy Uterine Bleeding focused on measuring Uterine Fibroids, Leiomyomata, Elagolix, Menorrhagia, Elagolix sodium, Heavy Uterine Bleeding, ABT-620
Eligibility Criteria
Inclusion Criteria:
- Subject is pre-menopausal female 18 to 51 years of age at Screening.
- Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.
- Subject has heavy uterine bleeding associated with uterine fibroids.
Exclusion Criteria:
- Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening.
- Subject has a history of osteoporosis or other metabolic bone disease.
- Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide.
- Subject has a history of clinically significant condition(s) including but not limited to: * Symptomatic Endometriosis * Epilepsy or seizures * Type 1 diabetes * Chronic kidney disease * Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Placebo Comparator
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Cohort 1: Placebo
Cohort 1: Elagolix 300 mg BID
Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD
Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD
Cohort 2: Placebo
Cohort 2: Elagolix 600 mg QD
Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD
Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD
Placebo for elagolix and placebo for E2/NETA twice daily (BID)
Elagolix 300 mg BID alone
Elagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD)
Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD
Placebo for elagolix and E2/NETA QD
Elagolix 600 mg QD alone
Elagolix 600 mg QD plus LD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD