Conditions: Heavy Uterine Bleeding Uterine Fibroids
Keywords: Uterine Fibroids Heavy Uterine Bleeding Elagolix Menorrhagia ABT-620 Leiomyomata Elagolix sodium
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 271
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Participants received elagolix 400 mg once a day (QD) for 3 months. arm 2: Participants received elagolix 100 mg twice a day (BID) for 3 months. arm 3: Participants received placebo to elagolix BID for 3 months. arm 4: Participants received elagolix 200 mg twice a day for 3 months. arm 5: Participants received placebo to elagolix twice a day for 3 months. arm 6: Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. arm 7: Participants received elagolix 600 mg once a day for 3 months. arm 8: Participants received elagolix 300 mg twice a day for 3 months. arm 9: Participants received placebo to elagolix BID for 3 months. arm 10: Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.

Interventions: intervention 1: Elagolix intervention 2: Placebo intervention 3: Estradiol/Norethindrone acetate (E2/NETA) intervention 4: Estradiol intervention 5: Progesterone
Intervention descriptions: intervention 1: Elagolix tablets intervention 2: Matching placebo tablets intervention 3: A continuous once-daily oral tablet containing estrogen and progestin; the low-dose strength contains estradiol 0.5 mg and norethindrone acetate 0.1 mg. intervention 4: 1.0 mg micronized estradiol tablets administered once a day intervention 5: Progesterone 200 mg administered during the last 12 days of the 28-day menstrual cycle

Protocol document: