Oral
ulipristal acetate (Esmya®; Fibristal®), a synthetic selective
progesterone receptor modulator, is the first selective
progesterone modulator to be approved for the treatment of
uterine fibroids. It was initially approved for the preoperative treatment of moderate to severe
uterine fibroid symptoms in women of reproductive age. Recently, the indication was extended in the EU to include the intermittent treatment of moderate to severe
uterine fibroid symptoms. This narrative review summarizes pharmacological, efficacy and tolerability data relevant to the preoperative and intermittent use of
ulipristal acetate in patients with symptomatic
uterine fibroids.
Ulipristal acetate is an effective and generally well tolerated treatment for patients with symptomatic
uterine fibroids, both as preoperative, single-course treatment and as intermittent, longer-term treatment. It is noninferior in efficacy to intramuscular
leuprolide acetate, as a preoperative treatment, and is associated with a lower rate of
hot flashes, a common adverse event with
gonadotropin-releasing hormone analogues. Thus,
ulipristal acetate is an effective option for both preoperative and intermittent treatment of moderate to severe, symptomatic
uterine fibroids in women of reproductive age.