Soňa Pánková, Robert Hudeček
Authors introduce final results of the PEARL IV study, which have confirmed effectiveness and safety of ulipristal acetate
(Esmya®, GedeonRichter) dosed 5 and 10 mg once a day during intermittent treatment of symptomatic uterine myomas.
A double-blinded study with 451 patients was carried out. There were four twelve-week therapeutic cycles dosed
as mentioned above. In this study, ulipristal acetate managed to control bleeding, make myomas smaller, relieve pain
and increase the quality of life. The effectiveness of studied parameters, compared to the initial values, was also evident
at times between cycles of treatment and three months after the treatment had ended. Both dosages of ulipristal
acetate were well tolerated, and there was a high level of patients’ compliance with the treatment. No differences
in safety were detected including thoroughly monitored endometrial changes and laboratory parameters between the
dosages. The recent approval of intermittent treatment with ulipristal acetate proves these results as a significant piece
of information for doctors in clinical practice.