title: 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.
abstract: 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 3months each, followed by a break to allow two menstruations to occur. We report 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.
  
  
  
  In this randomized multi-arm study, vilaprisan (2mg daily) will be administered in different regimens: continuous treatment for 12 or 24weeks, 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 (5mg daily) and placebo. Patients randomized to receive placebo for 12weeks will also be given active treatment for 12weeks. 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.
  
  
  
  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.
authors.affiliation: Bayer AG, Development, Gynecologic Therapies, 13342 Berlin, Germany. Electronic address: christian.seitz@bayer.com.
authors.forename: Christian
authors.initials: C
authors.lastname: Seitz
authors.affiliation: Vilnius University Faculty of Medicine, Clinic of Obstetrics and Gynaecology, Santariskiu str. 2, Vilnius LT-08406, Lithuania. Electronic address: zana.bumbuliene@santa.lt.
authors.forename: Žana
authors.initials: Ž
authors.lastname: Bumbuliene
authors.affiliation: Serviço de Ginecologia e Obstetrícia, Hospital de São João, 4200-319 Porto, Portugal. Electronic address: anacosta.md@gmail.com.
authors.forename: Ana Rosa
authors.initials: AR
authors.lastname: Costa
authors.affiliation: Department of Obstetrics and Gynaecology, University of Helsinki and Helsinki University Hospital, PL 610, 00029 HUS, Finland. Electronic address: oskari.heikinheimo@helsinki.fi.
authors.forename: Oskari
authors.initials: O
authors.lastname: Heikinheimo
authors.affiliation: Praxis für Gynäkologie und Geburtshilfe, Steinstrasse 6a, D-06406 Bernburg, Germany. Electronic address: a.heweker@t-online.de.
authors.forename: Andrea
authors.initials: A
authors.lastname: Heweker
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Masaryk University and University Hospital Brno, Obilní trh 11, 602 00 Brno, Czech Republic. Electronic address: rhudecek@fnbrno.cz.
authors.forename: Robert
authors.initials: R
authors.lastname: Hudeček
authors.affiliation: Department of Obstetrics and Gynaecology, UZA Antwerp University Hospital, Wilrijkstraat 10, 2650 Edegem, Belgium. Electronic address: yves.jacquemyn@uza.be.
authors.forename: Yves
authors.initials: Y
authors.lastname: Jacquemyn
authors.affiliation: Dipartimento di Scienze Chirurgiche, Clinica Ostetrica e Ginecologica, Università di Cagliari, SS 554, Bivio Sestu, 09042 Monserrato, Cagliari, Italy. Electronic address: gineca.gbmelis@tiscali.it.
authors.forename: Gian Benedetto
authors.initials: GB
authors.lastname: Melis
authors.affiliation: Nesttun Spesialistpraksis, Østre Nesttunveien 14, 5221 Nesttun, Bergen, Norway. Electronic address: ipooja1329@gmail.com.
authors.forename: Pooja
authors.initials: P
authors.lastname: Parashar
authors.affiliation: Second Chair and Department of Gynaecology, Medical University of Lublin, ul. K. Jaczewskiego 8, 20-090 Lublin, Poland. Electronic address: rechbergt@yahoo.com.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Rechberger
authors.affiliation: Hospital Clínico Universitario de Valencia, Av. de Blasco Ibáñez 15, 46010 València, Spain. Electronic address: antonio.cano@uv.es.
authors.forename: Antonio Cano
authors.initials: AC
authors.lastname: Sánchez
authors.affiliation: Flevoziekenhuis, Hospitaalweg 1, 1315 RA Almere, Netherlands. Electronic address: BvAken@Flevoziekenhuis.nl.
authors.forename: Bart
authors.initials: B
authors.lastname: van Aken
authors.affiliation: Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Magan Rendelo, 48 Szent Anna utca, Debrecen, Hungary. Electronic address: jzatik@yahoo.com.
authors.forename: János
authors.initials: J
authors.lastname: Zatik
authors.affiliation: Department of Women's and Children's Health (KBH), K6, Karolinska Universitetssjukhuset Solna, H2:00, 17176 Stockholm, Sweden. Electronic address: kristina.gemzell@ki.se.
authors.forename: Kristina
authors.initials: K
authors.lastname: Gemzell-Danielsson
mesh_terms: D000293:Adolescent; D000328:Adult; D003271:Contraceptive Agents, Female / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy*; D008875:Middle Aged; D009649:Norpregnadienes / Q000627:therapeutic use*; D011788:Quality of Life; D012107:Research Design; D013256:Steroids / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D003271:Contraceptive Agents, Female; D009649:Norpregnadienes; D013256:Steroids; C586669:vilaprisan; C555622:ulipristal acetate
keywords: Amenorrhoea; Progesterone receptor modulator; Ulipristal acetate; Uterine fibroids; Vilaprisan