Ulipristal Acetate Impact on Fibroid Volume: Integrated Results From VENUS I and II
ACOG ePoster. Lukes A. Apr 27, 2018; 211481
Andrea Lukes
Andrea Lukes
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Abstract
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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
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