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• W2891472010 abstract "This integrated analysis of ASTEROID 1 and 2 aimed to assess the efficacy and safety of the highly selective PRM vilaprisan (VPR) in women with uterine fibroids (UF), using an extended patient dataset. ASTEROID 1 and 2 are multicenter, randomized, double-blind, multi-arm, phase 2 studies conducted in women with at least one UF ≥3 cm and heavy menstrual bleeding (HMB) >80 mL. In ASTEROID 1, women were randomized to VPR 0.5 mg, 1 mg, 2 mg or 4 mg once daily (OD) or placebo for 12 weeks. In ASTEROID 2, women were randomized to VPR 2 mg, ulipristal acetate (UPA) 5 mg, or placebo OD for one/two 12-week treatment periods. An integrated analysis of women randomized to VPR 2 mg, UPA and placebo treatment for 12 weeks in ASTEROID 1 and 2 was performed. Amenorrhea (<2 mL per 28 days), HMB response (<80 mL and >50% reduction in bleeding from baseline during the third 28-day reference period of the treatment period) and controlled bleeding (<80 mL) were measured by menstrual pictogram. Time to onset was the first day at which the parameter of interest (through to all subsequent 28-day periods) started. Change in volume of the three largest fibroids from baseline to the end of treatment period was assessed by MRI. Health-related quality of life and symptom severity were measured by patient questionnaires. Adverse events and laboratory parameters were monitored, and endometrium was assessed by biopsy. 267 women completed 12 weeks of treatment (VPR n=128; UPA n=68; placebo n=71). Amenorrhea, HMB response and controlled response rates have been reported previously. Median time to onset of amenorrhea was 6 (interquartile range [IQR] 5-10) and 7 (IQR 5-10) days for VPR and UPA, respectively. Median time to onset of both HMB response and controlled bleeding was 3 days (IQR 2-4 and 1-4, respectively) for both VPR and UPA. No median values could be calculated for placebo. At 12 weeks, for the three largest fibroids, mean reductions in volume (standard deviation [SD]) of 28.9% (27.9) with VPR 2 mg and 23.8% (29.1) with UPA 5 mg were observed, and an increase of 6.9% (34.5) for placebo. VPR treatment was associated with clinically meaningful decreases in symptom severity and improvements in health-related quality of life. No unexpected safety issues were identified, no critical endometrial findings or findings indicative of liver toxicity were observed. VPR 2 mg rapidly induced amenorrhea and controlled bleeding, and decreased UF size. VPR was well tolerated, with no unexpected findings observed during monitoring of hepatic and endometrial safety. This integrated analysis considers a larger patient dataset to support existing evidence from ASTEROID 1 and 2 and reports on additional parameters." @default.
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• W2891472010 date "2018-09-01" @default.
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• W2891472010 title "Efficacy and safety of the selective progesterone receptor modulator (PRM) vilaprisan: integrated analysis of phase 2 asteroid 1 and 2 studies" @default.
• W2891472010 doi "https://doi.org/10.1016/j.fertnstert.2018.07.400" @default.
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