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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F17%3A00067290" target="_blank" >RIV/65269705:_____/17:00067290 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216224:14110/17:00097318

Výsledek na webu

<a href="http://www.sciencedirect.com/science/article/pii/S1551714416302270?via%3Dihub" target="_blank" >http://www.sciencedirect.com/science/article/pii/S1551714416302270?via%3Dihub</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.cct.2017.02.002" target="_blank" >10.1016/j.cct.2017.02.002</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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 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. 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. (C) 2017 Bayer AG. Published by Elsevier Inc.

Název v anglickém jazyce

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

Popis výsledku anglicky

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 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. 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. (C) 2017 Bayer AG. Published by Elsevier Inc.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30214 - Obstetrics and gynaecology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2017

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Contemporary Clinical Trials

ISSN

1551-7144

e-ISSN

—

Svazek periodika

55

Číslo periodika v rámci svazku

2017

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

7

Strana od-do

56-62

Kód UT WoS článku

000397692100008

EID výsledku v databázi Scopus

—