THURSDAY, July 1 (HealthDay News) -- Ulipristal acetate (UPA), a selective progesterone receptor modulator, appears to be effective as a non-surgical, potentially fertility-sparing treatment for uterine fibroids that also improves quality of life, according to research presented at the annual meeting of the European Society of Human Reproduction and Embryology, held from June 27 to 30 in Rome.
Alicia Armstrong, M.D., and Lynnette K. Nieman, M.D., of the National Institutes of Health in Bethesda, Md., pooled data from two phase II studies involving 57 women with symptomatic uterine fibroids randomized to receive UPA 10 mg (20 patients), UPA 20 mg (19 patients), or placebo (18 patients) daily for three menstrual cycles.
The researchers found a greater reduction of fibroid volume in women receiving UPA 10 mg and UPA 20 mg versus placebo. Both UPA groups experienced significantly less bleeding than the placebo group, and 80 and 95 percent of the women in the UPA 10 mg and UPA 20 mg groups, respectively, experienced amenorrhea in the third month. Estradiol levels remained adequate in 77, 100, and 95 percent of the UPA 10 mg, UPA 20 mg, and placebo groups, respectively. In addition, patients in the UPA groups scored higher in assessment of their quality of life, their mood and energy levels, and their overall concern about the effects of fibroids.
"UPA treatment is well tolerated and effectively reduces fibroid size, controls bleeding, and improves [quality of life] in patients with symptomatic uterine fibroids. This prospective new medical treatment therefore has the potential to aid in the preservation of fertility. Building on these promising results, two randomized Phase III trials (PEARL I and PEARL II) involving 540 patients in 14 countries are investigating UPA in women with symptomatic uterine fibroids," the authors write.
The research was funded in part by HRA Pharma.
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