| DONNEZ, Jacques, Robert HUDEČEK, Olivier DONNEZ, Dace MATULE, Hans-Joachim ARHENDT, Janos ZATIK, Zaneta KASILOVSKIENE, Mihai Cristian DUMITRASCU, Hervé FERNANDEZ, David H. BARLOW, Philippe BOUCHARD, Bart C.J.M. FAUSER, Elke BESTEL, Paul TERRILL, Ian OSTERLOH and Ernest LOUMAYE. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertility and Sterility. New York: Elsevier Science Inc., 2015, vol. 103, No 2, p. 519-527. ISSN 0015-0282. Available from: https://dx.doi.org/10.1016/j.fertnstert.2014.10.038. |
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@article{1218602,
author = {Donnez, Jacques and Hudeček, Robert and Donnez, Olivier and Matule, Dace and Arhendt, HansandJoachim and Zatik, Janos and Kasilovskiene, Zaneta and Dumitrascu, Mihai Cristian and Fernandez, Hervé and Barlow, David H. and Bouchard, Philippe and Fauser, Bart C.J.M. and Bestel, Elke and Terrill, Paul and Osterloh, Ian and Loumaye, Ernest},
article_location = {New York},
article_number = {2},
doi = {http://dx.doi.org/10.1016/j.fertnstert.2014.10.038},
keywords = {Repeated intermittent use; ulipristal acetate; uterine fibroid; quality of life; long-term treatment},
language = {eng},
issn = {0015-0282},
journal = {Fertility and Sterility},
title = {Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids},
volume = {103},
year = {2015}
}
TY - JOUR
ID - 1218602
AU - Donnez, Jacques - Hudeček, Robert - Donnez, Olivier - Matule, Dace - Arhendt, Hans-Joachim - Zatik, Janos - Kasilovskiene, Zaneta - Dumitrascu, Mihai Cristian - Fernandez, Hervé - Barlow, David H. - Bouchard, Philippe - Fauser, Bart C.J.M. - Bestel, Elke - Terrill, Paul - Osterloh, Ian - Loumaye, Ernest
PY - 2015
TI - Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids
JF - Fertility and Sterility
VL - 103
IS - 2
SP - 519-527
EP - 519-527
PB - Elsevier Science Inc.
SN - 00150282
KW - Repeated intermittent use
KW - ulipristal acetate
KW - uterine fibroid
KW - quality of life
KW - long-term treatment
N2 - Objective: To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily of ulipristal acetate for intermittent treatment of symptomatic uterine fibroids. Design: Double-blind, randomized administration of two 12-week courses of ulipristal acetate. Setting: Gynecology centers. Patient(s): A total of 451 patients with symptomatic uterine fibroid(s) and heavy bleeding. Intervention(s): Two repeated 12-week treatment courses of daily 5 or 10 mg of ulipristal acetate. Main Outcome Measure(s): Amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), pain. Result(s): In the 5- and 10-mg treatment groups (62% and 73% of patients, respectively) achieved amenorrhea during both treatment courses. Proportions of patients achieving controlled bleeding during two treatment courses were >80%. Menstruation resumed after each treatment course and was diminished compared with baseline. After the second treatment course, median reductions from baseline in fibroid volume were 54% and 58% for the patients receiving 5 and 10 mg of ulipristal acetate, respectively. Pain and QoL improved in both groups. Ulipristal acetate was well tolerated with less than 5% of patients discontinuing treatment due to adverse events.
ER -
DONNEZ, Jacques, Robert HUDEČEK, Olivier DONNEZ, Dace MATULE, Hans-Joachim ARHENDT, Janos ZATIK, Zaneta KASILOVSKIENE, Mihai Cristian DUMITRASCU, Hervé FERNANDEZ, David H. BARLOW, Philippe BOUCHARD, Bart C.J.M. FAUSER, Elke BESTEL, Paul TERRILL, Ian OSTERLOH and Ernest LOUMAYE. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. \textit{Fertility and Sterility}. New York: Elsevier Science Inc., 2015, vol.~103, No~2, p.~519-527. ISSN~0015-0282. Available from: https://dx.doi.org/10.1016/j.fertnstert.2014.10.038.
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