Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Brief Summary: This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.


Options:
A: Arm Label: Cohort 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Elagolix placebo, Drug: E2/NETA placebo | Arm Label: Cohort 1: Elagolix 300 mg BID; Type: EXPERIMENTAL; Interventions: Drug: Elagolix, Drug: E2/NETA placebo | Arm Label: Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD; Type: EXPERIMENTAL; Interventions: Drug: Elagolix, Drug: 0.5 mg estradiol / 0.1 mg norethindrone acetate | Arm Label: Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD; Type: EXPERIMENTAL; Interventions: Drug: Elagolix, Drug: 1 mg estradiol / 0.5 mg norethindrone acetate | Arm Label: Cohort 2: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Elagolix placebo, Drug: E2/NETA placebo | Arm Label: Cohort 2: Elagolix 600 mg QD; Type: EXPERIMENTAL; Interventions: Drug: Elagolix, Drug: E2/NETA placebo | Arm Label: Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD; Type: EXPERIMENTAL; Interventions: Drug: Elagolix, Drug: 0.5 mg estradiol / 0.1 mg norethindrone acetate | Arm Label: Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD; Type: EXPERIMENTAL; Interventions: Drug: Elagolix, Drug: 1 mg estradiol / 0.5 mg norethindrone acetate | Intervention Type: OTHER; Name: Elagolix placebo; Assigned to Arm(s): Cohort 1: Placebo, Cohort 2: Placebo | Intervention Type: DRUG; Name: Elagolix; Assigned to Arm(s): 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: 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 | Intervention Type: DRUG; Name: 0.5 mg estradiol / 0.1 mg norethindrone acetate; Assigned to Arm(s): Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD, Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD | Intervention Type: DRUG; Name: 1 mg estradiol / 0.5 mg norethindrone acetate; Assigned to Arm(s): Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD, Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD | Intervention Type: DRUG; Name: E2/NETA placebo; Assigned to Arm(s): Cohort 1: Elagolix 300 mg BID, Cohort 1: Placebo, Cohort 2: Elagolix 600 mg QD, Cohort 2: Placebo
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Asoprisnil | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Asoprisnil | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Asoprisnil | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Asoprisnil; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Asoprisnil; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Asoprisnil; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 4
C: Arm Label: ulipristal acetate -20 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: ulipristal acetate 20 mg | Arm Label: ulipristal acetate - 10 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: ulipristal acetate 10 mg | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: Pre-ulipristal acetate 10 mg; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Pre-ulipristal acetate 20 mg; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Pre-placebo; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: ulipristal acetate 20 mg; Assigned to Arm(s): ulipristal acetate -20 mg | Intervention Type: DRUG; Name: ulipristal acetate 10 mg; Assigned to Arm(s): ulipristal acetate - 10 mg | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo
D: Arm Label: Cohort 4 Elagolix 400 mg QD; Type: EXPERIMENTAL; Interventions: Drug: Elagolix | Arm Label: Cohort 4 Elagolix 100 mg BID; Type: EXPERIMENTAL; Interventions: Drug: Elagolix | Arm Label: Cohort 4 Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Cohort 1 Elagolix 200 mg BID; Type: EXPERIMENTAL; Interventions: Drug: Elagolix | Arm Label: Cohort 1 Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Cohort 3 Elagolix 200 mg BID + LD E2/NETA; Type: PLACEBO_COMPARATOR; Interventions: Drug: Elagolix, Drug: Estradiol/Norethindrone acetate (E2/NETA) | Arm Label: Cohort 5 Elagolix 600 mg QD; Type: EXPERIMENTAL; Interventions: Drug: Elagolix | Arm Label: Cohort 2 Elagolix 300 mg BID; Type: EXPERIMENTAL; Interventions: Drug: Elagolix | Arm Label: Cohort 2 Placebo; Type: EXPERIMENTAL; Interventions: Drug: Placebo | Arm Label: Cohort 6 Elagolix 300 mg BID + CEP; Type: EXPERIMENTAL; Interventions: Drug: Elagolix, Drug: Estradiol, Drug: Progesterone | Intervention Type: DRUG; Name: Elagolix; Assigned to Arm(s): Cohort 1 Elagolix 200 mg BID, Cohort 2 Elagolix 300 mg BID, Cohort 3 Elagolix 200 mg BID + LD E2/NETA, Cohort 4 Elagolix 100 mg BID, Cohort 4 Elagolix 400 mg QD, Cohort 5 Elagolix 600 mg QD, Cohort 6 Elagolix 300 mg BID + CEP | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cohort 1 Placebo, Cohort 2 Placebo, Cohort 4 Placebo | Intervention Type: DRUG; Name: Estradiol/Norethindrone acetate (E2/NETA); Assigned to Arm(s): Cohort 3 Elagolix 200 mg BID + LD E2/NETA | Intervention Type: DRUG; Name: Estradiol; Assigned to Arm(s): Cohort 6 Elagolix 300 mg BID + CEP | Intervention Type: DRUG; Name: Progesterone; Assigned to Arm(s): Cohort 6 Elagolix 300 mg BID + CEP

Answer: A