Does the Selective Progesterone Receptor Modulator Ulipristal Normalize the Uterine Cavity in Women with Leiomyoma?

Abstract

Objective: A number of studies, including a 2006 investigation by our group, have shown that distortion of the uterine cavity in women with fi broids is associated with lower pregnancy rates and increased miscarriage rates. Our objective was to determine if three months chronic daily administration of CDB-2914 (Ulipristal), a selective progesterone receptor modulator in cycling women with leimyomata, will reduce leiomyoma size and normalize the uterine cavity. Materials and Methods: Data were pooled from two randomized, placebocontrolled, double-blind studies. Women aged 33-50 years with symptomatic uterine fi broids were randomized to receive oral ulipristal acetate (10 or 20 mg) or placebo once-daily for 12 weeks. Saline sonohysterography was performed at baseline and at the end of treatment. Results: 28 patients had abnormal sonohysterogram results at baseline n= 9, n= 8 and n=11 for placebo, UPA 10mg and UPA 20 mg respectively. At the end of treatment 22% of the placebo group, 38% of the 10mg group and 27% of the 20 mg group had normal uterine cavities. When the 10 mg and 20 mg groups were combined, 32% of the patients had normal uterine cavities post treatment.(Figure 1)Conclusion: If these results are confi rmed in larger randomized studies, Ulipristal may offer an alternative to surgical therapy for women requiring normalization of the uterine cavity. (Figure presented).