Title: Ulipristal Acetate versus Placebo for Fibroid Treatment before Surgery
Journal: New England Journal of Medicine, February, 2012
Authors: Donnez J, Tatarchuk T, Bouchard P, and others
Study from: Brussels, Russia, France, Romania, Hungary, Switzerland, England
Problem: There are no currently effective and safe pills for treatment of uterine fibroid symptoms.
Study: Women with heavy bleeding due to fibroids were randomly assigned to take either ulipristal, a medication that blocks progesterone’s effect on fibroids, or a placebo. Ulipristal does not lower estrogen production by the ovary and is not associated with hot flashes, vaginal dryness or other menopausal symptoms like previously tested treatments.
Results: After 13 weeks, bleeding was controlled in 91% of women taking ulipristal compared with only 19% of women taking a placebo. In addition, fibroid size decreased 21%. Side effects of hot flashes, vaginal dryness, headaches or breast tenderness were no more common with ulipristal than with placebo.
Authors’ Conclusions: Treatment with ulipristal for 13 weeks controlled excessive bleeding due to fibroids and reduced fibroid size.
Dr. Parker’s Comments: It would be a major treatment breakthrough if there were an oral medication, without side-effects, to effectively decrease heavy bleeding and decrease fibroid size. So far, medications have either not been effective (progesterone), or they have had bothersome side-effects (Lupron), or they have had negative effects on the uterus (Asoprisnil, Mefipristone).
This study shows ulipristal can help with bleeding and help shrink fibroids, but the final word is not in yet. All of the progesterone blocking drugs tested so far have caused thickening of the uterine lining cells and some have even caused pre-cancerous cells to develop. Although based on the way ulipristal works, this is much less likely to happen with ulipristal, a longer test of the medication will be necessary to know if it is safe for sure. This drug is currently available in the US as Ella 1 as an emergency contraceptive pill. However, it requires a prescription and costs about $50 per day! I imagine ulipristal is unlikely to be approved by the FDA for treatment of fibroids until the longer studies are finished. But, it may be something that really adds to the treatment options we have for women with fibroids.
