69485
document
Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids . 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 . CONCLUSION ( S ) Repeated 12-week courses of daily oral ulipristal acetate ( 5 and 10 mg ) effectively control bleeding and pain , reduce fibroid volume , and restore QoL in patients with symptomatic fibroids . CLINICAL TRIAL REGISTRATION NUMBER NCT01629563 ( PEARL IV ) .
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Intervention_Pharmacological
ulipristal acetate
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Intervention_Pharmacological
ulipristal acetate
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Intervention_Pharmacological
ulipristal acetate
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Intervention_Pharmacological
5 or 10 mg of ulipristal acetate
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Outcome_Other
Efficacy
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Outcome_Other
safety
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Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Physical
Amenorrhea , controlled bleeding , fibroid volume ,
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Outcome_Other
quality of life ( QoL )
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Outcome_Other
pain
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Outcome_Physical
amenorrhea
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Outcome_Physical
controlled bleeding
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Outcome_Physical
Menstruation resumed
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Outcome_Physical
median reductions from baseline in fibroid volume
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Outcome_Pain
Pain
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Outcome_Other
QoL
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Outcome_Other
tolerated
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Outcome_Adverse-effects
adverse events .
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Outcome_Physical
bleeding
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Outcome_Pain
pain
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Outcome_Physical
fibroid volume
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Outcome_Other
QoL
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Participant_Condition
uterine fibroids .
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Participant_Condition
symptomatic uterine fibroids .
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Participant_Condition
Gynecology centers .
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Participant_Sample-size
451
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Participant_Condition
symptomatic uterine fibroid ( s ) and heavy bleeding