J 2020

Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2

GEMZELL-DANIELSSON, Kristina, Oskari HEIKINHEIMO, Janos ZATIK, Robert POKA, Tomasz RECHBERGER et. al.

Basic information

Original name

Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2

Authors

GEMZELL-DANIELSSON, Kristina (752 Sweden), Oskari HEIKINHEIMO (246 Finland), Janos ZATIK (348 Hungary), Robert POKA (348 Hungary), Tomasz RECHBERGER (616 Poland), Robert HUDEČEK (203 Czech Republic, belonging to the institution), Kathrin PETERSDORF (276 Germany), Francisco RAMIREZ (276 Germany), Thomas FAUSTMANN (276 Germany), Esther GROETTRUP-WOLFERS and Christian SEITZ (276 Germany, guarantor)

Edition

EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY, AMSTERDAM, ELSEVIER SCIENCE BV, 2020, 0301-2115

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30214 Obstetrics and gynaecology

Country of publisher

Germany

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

Impact factor

Impact factor: 2.435

RIV identification code

RIV/00216224:14110/20:00116813

Organization unit

Faculty of Medicine

DOI

UT WoS

000573036000002

Keywords in English

Vilaprisan; Heavy menstrual bleeding; Uterine fibroids; Amenorrhea; Selective progesterone receptor modulator

Tags

Tags

International impact, Reviewed
Změněno: 11/11/2020 11:19, Mgr. Tereza Miškechová

Abstract

V originále

Objective: To assess the efficacy of vilaprisan compared with placebo in the management of the symptoms of uterine fibroids (UF), with a secondary objective to provide a descriptive comparison with ulipristal acetate. Study design: The randomized, parallel-group, double-blind, placeboand active-controlled, multicenter ASTEROID 2 trial assessed the efficacy and safety of vilaprisan versus placebo and ulipristal acetate for two 12-week treatment periods in women with >1 UF experiencing heavy menstrual bleeding (HMB). The primary endpoint compared the efficacy of vilaprisan with placebo at 12 weeks, assessed as the absence of bleeding/spotting by bleeding diary. Secondary endpoints compared the efficacy of vilaprisan with ulipristal acetate. Results of the first 12-week treatment period are reported here. Results: Women (mean age 42.5 years) were enrolled from 1 June 2015. At baseline, mean menstrual blood loss per 28 days was 214.1 mL and the volume of the three largest UF was 106.2 mL. In total, 155 women completed the initial 12-week treatment period. Complete absence of bleeding/spotting until the end of the 12-week treatment period was achieved by 62.9 % of women receiving vilaprisan versus 0.0 % with placebo (p < .001); 55.4 % of women treated with ulipristal acetate reported absence of bleeding/spotting. The predefined HMB response (80 mL and 50 % reduction from baseline during the last 28 days of treatment) was observed in 95.7 % of subjects treated with vilaprisan and 86.5 % of subjects treated with ulipristal acetate. Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group. No safety concerns, including multiple laboratory parameters, were identified. Conclusion: Daily administration of vilaprisan 2 mg induced amenorrhea, controlled bleeding, decreased UF size, and was well tolerated in women with HMB associated with UF. (C) 2020 Published by Elsevier B.V.