Safety of treatment of uterine fibroids with the selective progesterone receptor modulator, ulipristal acetate

ABSTRACT

Introduction: During the last decade, there has been increased emphasis on the role of progesterone in the promotion of fibroid growth, as well as heightened interest in modulating progesterone pathways by use of selective progesterone receptor modulators (SPRMs). Among them, ulipristal acetate (UPA) has proved its efficacy in the management of symptomatic myomas by controlling bleeding and inducing amenorrhea, and reducing the size of myomas in the majority of cases.

Areas covered: In this review, we summarize published scientific studies exploring evidence of the safety of SPRMs and particularly UPA, a drug approved for the management of symptomatic uterine fibroids. We focus essentially on endometrial changes induced by UPA, and also evaluate other safety outcomes.

Expert opinion: Data from published reports of randomized controlled trials (RCTs) over 5 years have demonstrated that UPA does indeed induce endometrial changes (known as progesterone receptor modulator-associated endometrial changes), but they have been shown to be both benign and reversible.

KEYWORDS:

• Uterine fibroids
• selective progesterone receptors modulators
• ulipristal acetate
• safety
• PAECs (progesterone receptor modulator-associated endometrial changes)

Acknowledgments

The authors thank Mira Hryniuk, BA, for reviewing the English language of the manuscript, Deborah Godefroidt for her administrative help, and Pablo Arriagada and Helen Sanders for their help with data collection.

Declaration of interest

J Donnez has been member of the Scientific Advisory Board (SAB) of PregLem S.A. since 2007. Dr. DONNEZ reports grants and personal fees from Gedeon Richter Group. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This work was supported by the Fonds National de la Recherche Scientifique de Belgique-FNRS under Grant No 5/4/150/5 to Prof. Dolmans.