The potential role of elagolix for treating uterine bleeding associated to uterine myomas.
Fabio BarraSalvatore Giovanni VitaleMarta SecaCarolina ScalaUmberto Leone Roberti MaggioreAntonio CianciSimone FerreroPublished in: Expert opinion on pharmacotherapy (2020)
In two previous phase II studies, this drug succeeded in ameliorating blood loss and quality of life of patients affected by uterine myomas with a good safety profile. Three phase III trials (ELARIS UF-I, UF-II, and EXTEND) investigated the efficacy, tolerability, and safety of elagolix at 300 mg twice daily with add-back therapy. The primary endpoint, consisting in the reduction in HMB compared to placebo, was met in the majority of patients under treatment. Currently, elagolix is under investigation in two other ongoing multicenter phase III clinical studies.
Keyphrases
- phase iii
- open label
- phase ii
- end stage renal disease
- clinical trial
- double blind
- chronic kidney disease
- ejection fraction
- peritoneal dialysis
- newly diagnosed
- placebo controlled
- randomized controlled trial
- physical activity
- mesenchymal stem cells
- patient reported outcomes
- high resolution
- cross sectional
- electronic health record
- combination therapy
- atomic force microscopy
- case control