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Review
. 2016 Nov;12(6):544-548.
doi: 10.1177/1745505717692591. Epub 2017 Feb 13.

Esmya® and the PEARL studies: A review

Martin Powell  1 , Deborata Dutta  2
Affiliations
Review

Esmya® and the PEARL studies: A review

Martin Powell et al. Womens Health (Lond). 2016 Nov.

Abstract

Ulipristal acetate was investigated in four phase 3 trials. In PEARL I, ulipristal produced significant normalisation of blood loss within 1 week and decreased fibroid volume. In PEARL II, ulipristal produced faster and more consistent control of bleeding than leuprorelin acetate and had a more favourable side-effect profile. Ulipristal-induced decreases in fibroid volume persisted for 6 months, whereas fibroids regrew after leuprorelin was stopped. PEARL III showed that ulipristal was effective during long-term treatment, with norethisterone further reducing the magnitude of bleeding in the off-treatment period. PEARL IV investigated ulipristal over four cycles, finding little difference between 5 and 10 mg ulipristal, further changes in menstruation and fibroid volume with repeat courses, and no increase in side effects.

Keywords: PEARL trial; fibroids; selective progesterone receptor modulator; ulipristal acetate.

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Conflict of interest statement

Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

References

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