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

SEITZ, Christian, Žana BUMBULIENE, Ana Rosa COSTA, Oskari HEIKINHEIMO, Andrea HEWEKER, Robert HUDEČEK, Yves JACQUEMYN, Gian Benedetto MELIS, Pooja PARASHAR, Tomasz RECHBERGER, Antonio Cano SÁNCHEZ, Bart van AKENL, János ZATIK and Kristina GEMZELL-DANIELSSON. 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. CONTEMPORARY CLINICAL TRIALS. New York: Elsevier Science, 2017, vol. 55, APR 2017, p. 56-62. ISSN 1551-7144. Available from: https://dx.doi.org/10.1016/j.cct.2017.02.002.

Basic information

Original name

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 (276 Germany), Žana BUMBULIENE (440 Lithuania), Ana Rosa COSTA (620 Portugal), Oskari HEIKINHEIMO (246 Finland), Andrea HEWEKER (276 Germany), Robert HUDEČEK (203 Czech Republic, guarantor, belonging to the institution), Yves JACQUEMYN (56 Belgium), Gian Benedetto MELIS (380 Italy), Pooja PARASHAR (578 Norway), Tomasz RECHBERGER (616 Poland), Antonio Cano SÁNCHEZ (724 Spain), Bart van AKENL (528 Netherlands), János ZATIK (348 Hungary) and Kristina GEMZELL-DANIELSSON (752 Sweden)

Edition

CONTEMPORARY CLINICAL TRIALS, New York, Elsevier Science, 2017, 1551-7144

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Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30104 Pharmacology and pharmacy

Country of publisher

Netherlands

Confidentiality degree

není předmětem státního či obchodního tajemství

Impact factor

Impact factor: 2.658

RIV identification code

RIV/00216224:14110/17:00097318

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.cct.2017.02.002

UT WoS

000397692100008

Keywords in English

Vilaprisan; Progesterone receptor modulator;Uterine fibroids;Ulipristal acetate;Amenorrhoea

Tags

EL OK

Tags

International impact, Reviewed

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Abstract

V originále

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/).