Table 1 Characteristics of included trial
Reference | Country | Participants | Inclusion study period/ Treatment period | Intervention | Elagolix dosage and frequency administration | Comparator | No of participants/ No of trial sites | No of missing | |
|---|---|---|---|---|---|---|---|---|---|
Age group; mean baseline MBL | Mean baseline uterine volume / mean baseline fibroid volume | ||||||||
Archer 2017 | USA | 20–49 years; 267 mL | 535 ± 389 cm3 / 91 ± 175 cm3 | September 2011-May 2014/ 3 months | Elagolix (ABT-620) | i; 100 mg bd ii; 200 mg bd iii; 300 mg bd iv; 400 mg qd v; 600 mg qd | i; placebo (matching placebo tablet) ii; 0.5 mg E2/ 0.1 md NETA | 271/ 45 | Intervention (29) Control (14) |
Carr 2018 | USA | 18–51 years; 246 ± 180 mL | 628 ± 462 cm3/ 150 ± 196 cm3 | April 2013-Dec 2015/ 6 months | Elagolix (ABT-620) | i; 300 mg bd ii; 600 mg qd | i; placebo (Oral coated placebo) ii; 0.5 mg E2/ 0.1 mg NETA iii; 1.0 mg E2/ 0.5 mg NETA | 571*/ 86 *4 women were randomized but not treated | Intervention (32) Control (97) |
Schlaff 2020 | USA | (UF-1) 18–51 years; 245 ± 161 mL (UF-2) 18–51 years; 234 ± 156 mL | (UF-1) 482 ± 393 cm3 / 50 ± 68.9 cm3 (UF-2) 519 ± 437 cm3 / 63 ± 111 cm3 | (UF-1) Dec 2015- Dec 2018/ 6 months (UF-2) Feb 2016 – Feb 2018 / 6 months | Elagolix (ABT-620) | i; 300 mg bd | i; placebo (film coated placebo tab) ii; 1.0 mg E2/ 0.5 mg NETA | (UF-1) 413 (UF-2) 378 /77 | (UF-1) Intervention (23) Control (62) (UF-2) Intervention (26) Control (63) |
Simon 2020 UF EXTEND | USA | 18–51 years; 236 ± 159 mL | 519 ± 457 cm3 / 59 ± 97 cm3 | September 2016- Mac 2019/ 12 months | Elagolix (ABT-620) | i; 300 mg bd | i; 1.0 mg E2/ 0.5 mg NETA | 316 out of 433 recruited*/ 115 *117 placebo participants exempted | Intervention (19) Control (36) |