Ulipristal Acetate Versus Placebo for Fibroid Treatment Before Surgery

Literature Review

Ulipristal acetate versus placebo for fibroid treatment before surgery. Donnez J, Tatarchuk TF, Bouchard P, Puscasiu L, Zakharenk NF, Ivanova T, Ugocsai G, Mara M, Jilla MP, Bestel E, Terrill P, Osterloh I, Loumaye E, for the PEARL I Study Group. NEJM. 2012 Feb 2, 366(5): 409-420.  

Reviewed by Dr. John Preston Parry, M.D., M.P.H.  

The purpose of this double blinded randomized controlled trial was to see if ulipristal acetate was more effective than placebo in treating women with symptomatic fibroids leading to anemia. 242 women were randomized to receive placebo or 5 mg or 10 mg of ulipristal acetate daily for 13 weeks. When starting ulipristal acetate by cycle day 4 of bleeding, 6% of placebo patients achieved amenorrhea prior to 13 weeks compared to 73% of those receiving 5 mg and 82% of those receiving 10 mg, with the majority of those achieving amenorrhea within 10 days of initiating therapy. The change in mean fibroid size over the study was a 3% increase in those assigned to placebo relative to a 21% decrease in those receiving the 5 mg dose and a 12% decrease in those receiving the 10 mg dose. Serious and minor adverse events appeared comparable among the three arms of the study. The authors conclude that ulipristal is effective in stopping bleeding and reducing fibroid volume. 

Comments by Dr. Steven R. Lindheim, M.D.

This study suggests that ullipristal seems to reduce fibroid volume, however, it is unclear whether surgery was easier with ulipristal relative to placebo including issues relative to capsular degeneration.

The above review and commentary on this article were written by SRS members. Publication of these summaries does not reflect endorsement of any particular procedure or treatment. Views expressed in these summaries do not necessarily reflect the views of SRS or ASRM. 


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