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

J 2017

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 et. al.

Základní údaje

Originální název

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

Autoři

SEITZ, Christian (276 Německo), Žana BUMBULIENE (440 Litva), Ana Rosa COSTA (620 Portugalsko), Oskari HEIKINHEIMO (246 Finsko), Andrea HEWEKER (276 Německo), Robert HUDEČEK (203 Česká republika, garant, domácí), Yves JACQUEMYN (56 Belgie), Gian Benedetto MELIS (380 Itálie), Pooja PARASHAR (578 Norsko), Tomasz RECHBERGER (616 Polsko), Antonio Cano SÁNCHEZ (724 Španělsko), Bart van AKENL (528 Nizozemské království), János ZATIK (348 Maďarsko) a Kristina GEMZELL-DANIELSSON (752 Švédsko)

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Nizozemské království

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 2.658

Kód RIV

RIV/00216224:14110/17:00097318

Organizační jednotka

Lékařská fakulta

DOI

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

UT WoS

000397692100008

Klíčová slova anglicky

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

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 17. 5. 2018 16:28, Soňa Böhmová

Anotace

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/).

Citovat

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 a 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, roč. 55, APR 2017, s. 56-62. ISSN 1551-7144. Dostupné z: https://dx.doi.org/10.1016/j.cct.2017.02.002.

@article{1386770,
   author = {Seitz, Christian and Bumbuliene, Žana and Costa, Ana Rosa and Heikinheimo, Oskari and Heweker, Andrea and Hudeček, Robert and Jacquemyn, Yves and Melis, Gian Benedetto and Parashar, Pooja and Rechberger, Tomasz and Sánchez, Antonio Cano and Akenl, Bart van and Zatik, János and GemzellandDanielsson, Kristina},
   article_location = {New York},
   article_number = {APR 2017},
   doi = {http://dx.doi.org/10.1016/j.cct.2017.02.002},
   keywords = {Vilaprisan; Progesterone receptor modulator;Uterine fibroids;Ulipristal acetate;Amenorrhoea},
   language = {eng},
   issn = {1551-7144},
   journal = {CONTEMPORARY CLINICAL TRIALS},
   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},
   volume = {55},
   year = {2017}
}

TY  - JOUR
ID  - 1386770
AU  - 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
PY  - 2017
TI  - 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
JF  - CONTEMPORARY CLINICAL TRIALS
VL  - 55
IS  - APR 2017
SP  - 56-62
EP  - 56-62
PB  - Elsevier Science
SN  - 15517144
KW  - Vilaprisan
KW  - Progesterone receptor modulator;Uterine fibroids;Ulipristal acetate;Amenorrhoea
N2  - 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/).
ER  -

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 a 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. \textit{CONTEMPORARY CLINICAL TRIALS}. New York: Elsevier Science, 2017, roč.~55, APR 2017, s.~56-62. ISSN~1551-7144. Dostupné z: https://dx.doi.org/10.1016/j.cct.2017.02.002.

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