Endometrial safety of ulipristal acetate treatment for symptomatic uterine fibroids in premenopausal women - A systematic review

The aim of the present article was to evaluate endometrial safety of the ulipristal acetate (UPA) treatment for uterine symptomatic fibroids by reviewing the relevant studies and to provide confidence in SPRM (Selective Progesterone Receptor Modulators) clinical use. We designed a review protocol according to PRISMA guidelines and electronic databases search. The databases searched were PubMed, Embase and Cochrane for terms "ulipristal acetate", "endometrium" and "fibroid" or synonyms. After screening, 41 full-text studies were retained, with 9 included selected: 7 randomized controlled, one prospective observational case control and one off label including 1997 patients treated with UPA. Dosage, interval and endometrial aspects at biopsy were described. UPA-induced non-physiological histological changes of the endometrium were reported by 5 studies. The overall quality of the studies was good. No premalignant or malignant endometrial changes were reported. Evidences provided by the study are consistent-UPA can be prescribed for conservative or pre-surgical treatment of fibroids without concern on possible endometrial malignancies.