522
Views
23
CrossRef citations to date
0
Altmetric
Drug Safety Evaluation

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

, &
Pages 1679-1686 | Received 20 Jul 2016, Accepted 12 Oct 2016, Published online: 02 Nov 2016
 

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.

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.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.