Long-term medical management of uterine fibroids with ulipristal acetate

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F16%3A00065322" target="_blank" >RIV/65269705:_____/16:00065322 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216224:14110/16:00089363

Výsledek na webu

<a href="http://dx.doi.org/10.1016/j.fertnstert.2015.09.032" target="_blank" >http://dx.doi.org/10.1016/j.fertnstert.2015.09.032</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.fertnstert.2015.09.032" target="_blank" >10.1016/j.fertnstert.2015.09.032</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Long-term medical management of uterine fibroids with ulipristal acetate

Popis výsledku v původním jazyce

Objective: To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily ulipristal acetate for intermittent treatment of symptomatic uterine fibroids. Design: Double-blind, randomized administration of four 12-week courses of ulipristal acetate. Setting: Gynecology centers. Patient(s): Four hundred fifty-one subjects with symptomatic uterine fibroid(s) and heavy menstrual bleeding. Intervention(s): Four repeated 12-week treatment courses of daily 5 or 10 mg ulipristal acetate. Main Outcome Measure(s): Endometrial safety and general safety, laboratory parameters, amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), and pain. Result(s): Efficacy results, such as bleeding control and fibroid volume reduction, were in line with previously published data. Pain and QoL showed marked improvements from screening, even during the off-treatment intervals. The safety profile of ulipristal acetate was confirmed, and repeated treatment courses did not increase the occurrence of adverse reactions. There were no significant changes in laboratory parameters during the study. The percentage of subjects with endometrial thickness }= 16 mm was 7.4% (all subjects) after the first treatment course and returned to below screening levels (4.9%) in subsequent treatment courses. As in previous studies, ulipristal acetate did not increase the occurrence of endometrial features of concern. The frequency of nonphysiological changes did not increase with repeated treatment. They were observed in 17.8% and 13.3% of biopsies after treatment courses 2 and 4, respectively, and were reversible after treatment cessation. Conclusion(s): The results of this study demonstrate the efficacy and further support the safety profile of repeated intermittent treatment of symptomatic fibroids with ulipristal acetate. (C) 2016 The Authors. Published by Elsevier Inc. on behalf of the American Society for Reproductive Medicine.

Název v anglickém jazyce

Long-term medical management of uterine fibroids with ulipristal acetate

Popis výsledku anglicky

Objective: To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily ulipristal acetate for intermittent treatment of symptomatic uterine fibroids. Design: Double-blind, randomized administration of four 12-week courses of ulipristal acetate. Setting: Gynecology centers. Patient(s): Four hundred fifty-one subjects with symptomatic uterine fibroid(s) and heavy menstrual bleeding. Intervention(s): Four repeated 12-week treatment courses of daily 5 or 10 mg ulipristal acetate. Main Outcome Measure(s): Endometrial safety and general safety, laboratory parameters, amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), and pain. Result(s): Efficacy results, such as bleeding control and fibroid volume reduction, were in line with previously published data. Pain and QoL showed marked improvements from screening, even during the off-treatment intervals. The safety profile of ulipristal acetate was confirmed, and repeated treatment courses did not increase the occurrence of adverse reactions. There were no significant changes in laboratory parameters during the study. The percentage of subjects with endometrial thickness }= 16 mm was 7.4% (all subjects) after the first treatment course and returned to below screening levels (4.9%) in subsequent treatment courses. As in previous studies, ulipristal acetate did not increase the occurrence of endometrial features of concern. The frequency of nonphysiological changes did not increase with repeated treatment. They were observed in 17.8% and 13.3% of biopsies after treatment courses 2 and 4, respectively, and were reversible after treatment cessation. Conclusion(s): The results of this study demonstrate the efficacy and further support the safety profile of repeated intermittent treatment of symptomatic fibroids with ulipristal acetate. (C) 2016 The Authors. Published by Elsevier Inc. on behalf of the American Society for Reproductive Medicine.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FK - Gynekologie a porodnictví

OECD FORD obor

—

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2016

Kód důvěrnosti údajů

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

Název periodika

FERTILITY AND STERILITY

ISSN

0015-0282

e-ISSN

—

Svazek periodika

105

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

13

Strana od-do

165-"+"

Kód UT WoS článku

000373402600027

EID výsledku v databázi Scopus

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