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INTRODUCTION: Uterine fibroids (UFs) are common benign tumors that can cause heavy menstrual bleeding (HMB). Ulipristal acetate (UPA), an oral selective progesterone-receptor modulator, suppresses uterine bleeding and reduces fibroid cell size by inducing apoptosis and breakdown of the extracellular matrix. METHODS: In the randomized, double-blind, placebo-controlled, Phase III VENUS I and II studies, pre-menopausal women (18-50 years of age) with ≥1 UF and HMB were randomized to placebo, UPA 5 mg, or UPA 10 mg once daily for 12 weeks (one treatment course [TC] for VENUS I and two TCs for VENUS II), with a 12-week treatment-free follow up. Efficacy endpoints included mean change from baseline in total volume of (up to) the three largest UFs (measured by transvaginal ultrasound). VENUS I and II results were pooled only for the first TC for analysis of fibroid volume changes. RESULTS: Integrated results after the first TC demonstrated significant fibroid volume reduction from baseline with UPA 5 mg (n=170) vs placebo (n=125) (-11.4% and +6.8%, respectively; P=.0037) and UPA 10 mg (n=165) vs placebo (-14.2% and +6.8%, respectively; P<.001). After the second TC of UPA 5 mg (n=70) and 10 mg (n=59), further volume reduction was seen (-11.7% and -23.0%, respectively), which remained reduced at the 12-week treatment-free follow up (-16.0% and -31.5%, respectively). CONCLUSION: Both UPA doses, vs placebo, significantly reduce fibroid volume in women with UFs, with greater reduction observed with UPA 10 mg.

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