Publication details

Rationale and design of ASTEROID 2, a randomized, placebo- and active comparator-controlled study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids

Authors

SEITZ Christian BUMBULIENE Žana COSTA Ana Rosa HEIKINHEIMO Oskari HEWEKER Andrea HUDEČEK Robert JACQUEMYN Yves MELIS Gian Benedetto PARASHAR Pooja RECHBERGER Tomasz SÁNCHEZ Antonio Cano AKENL Bart van ZATIK János GEMZELL-DANIELSSON Kristina

Year of publication 2017
Type Article in Periodical
Magazine / Source CONTEMPORARY CLINICAL TRIALS
MU Faculty or unit

Faculty of Medicine

Citation
Doi http://dx.doi.org/10.1016/j.cct.2017.02.002
Field Gynaecology and obstetrics
Keywords Vilaprisan; Progesterone receptor modulator;Uterine fibroids;Ulipristal acetate;Amenorrhoea
Description Background: Uterine fibroids (UFs) may be treated with progesterone receptor modulators (PRMs), which have been shown to reduce heavy menstrual bleeding and the size of UFs. To date, one PRM (ulipristal acetate) has received regulatory approval for the treatment of UFs; therapy comprises intermittent treatment courses of up to 3 months each, followed by a break to allowtwo menstruations to occur.Wereport the design of ASTEROID (Assess Safety and efficacy of vilaprisan in patients with uTERine fibrOIDs) 2, a phase 2 study examining the efficacy and safety of a novel PRM, vilaprisan, in women with UFs. Methods/design: In this randomized multi-arm study, vilaprisan (2 mg daily) will be administered in different regimens: continuous treatment for 12 or 24 weeks, or two 12-week treatment periods separated by a break to allow one menstruation to occur. Efficacy and safety will be compared with that of ulipristal acetate (5 mg daily) and placebo. Patients randomized to receive placebo for 12 weeks will also be given active treatment for 12 weeks. The primary measure of efficacy will be amenorrhoea rate; secondary measures include time to normalized menstrual bleeding and percentage change in UF volume. Endometrial changes will be monitored throughout the study. Discussion: The placebo- and active comparator-controlled trial ASTEROID 2 is the first study to evaluate systematically the efficacy and safety of different treatment regimens of PRMs in women with UFs. The findings of this study will direct the planning of future clinical trials of vilaprisan. © 2017 Bayer AG. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).

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