Ulipristal Acetate versus Placebo for Fibroid Treatment before Surgery

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F12%3A13568" target="_blank" >RIV/00216208:11110/12:13568 - isvavai.cz</a>
Alternative codes found
RIV/00064165:_____/12:13568
Result on the web
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DOI - Digital Object Identifier
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Result language
angličtina
Original language name
Ulipristal Acetate versus Placebo for Fibroid Treatment before Surgery
Original language description
Background The efficacy and safety of oral ulipristal acetate for the treatment of symptomatic uterine fibroids before surgery are uncertain. Methods We randomly assigned women with symptomatic fibroids, excessive uterine bleeding (a score of >100 on thepictorial blood-loss assessment chart [PBAC, an objective assessment of blood loss, in which monthly scores range from 0 to >500, with higher numbers indicating more bleeding]) and anemia (hemoglobin level of <= 10.2 g per deci-liter) to receive treatment for up to 13 weeks with oral ulipristal acetate at a dose of 5 mg per day (96 women) or 10 mg per day (98 women) or to receive placebo (48 women). All patients received iron supplementation. The coprimary efficacy end points were control of uterine bleeding (PBAC score of <75) and reduction of fibroid volume at week 13, after which patients could undergo surgery. Results At 13 weeks, uterine bleeding was controlled in 91% of the women receiving 5 mg of ulipristal acetate, 92% of those
Czech name
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Czech description
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Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FK - Gynaecology and obstetrics
OECD FORD branch
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Publication year
2012
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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