Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase 2a Proof Of Concept Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
Brief Summary: The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.


Options:
A: 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
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: 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
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: D