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document
Low-dose mifepristone for uterine leiomyomata . OBJECTIVE To compare the effect of 5 and 10 mg of mifepristone on uterine leiomyoma size and symptoms , and to measure side effects . METHODS Forty premenopausal women with large , symptomatic leiomyomata were randomized to receive either 5 or 10 mg of mifepristone daily for 6 months in an open-label study . Uterine volume was measured at bimonthly intervals by sonography . Serum concentrations of hemoglobin levels , follicle-stimulating hormone , and liver enzymes were obtained , and endometrial samples , symptoms , and menstrual bleeding were also assessed . RESULTS Nineteen of 20 subjects taking 5 mg and all 20 subjects taking 10 mg completed all 6 months of the study . Mean uterine volume shrank by 48 % ( P < .001 ) in the 5-mg group and 49 % ( P < .001 ) in the 10-mg group , a nonsignificant difference . Leiomyoma-related symptoms were comparably reduced in both groups . Amenorrhea occurred in 60-65 % of both groups . Hemoglobin levels increased by 2.5 g/dL in anemic subjects . The incidence of hot flashes increased significantly over baseline in the 10-mg group but not in the 5-mg group . Simple endometrial hyperplasia occurred in 28 % of all subjects , with no difference between groups . No atypical hyperplasia was noted . CONCLUSION Mifepristone in doses of 5 mg or 10 mg results in comparable leiomyoma regression , improvement in symptoms , and few side effects . Further study is needed to assess the long-term safety and efficacy of low-dose mifepristone .
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Intervention_Pharmacological
mifepristone
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Intervention_Pharmacological
mifepristone
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Intervention_Pharmacological
receive either 5 or 10 mg of mifepristone daily for 6 months in an open-label study .
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Intervention_Pharmacological
Mifepristone
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Intervention_Pharmacological
mifepristone
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Outcome_Physical
uterine leiomyoma size and symptoms
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Outcome_Physical
Mean uterine volume shrank
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Outcome_Physical
Leiomyoma-related symptoms
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Outcome_Physical
Amenorrhea
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Outcome_Physical
Hemoglobin levels
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Outcome_Adverse-effects
hot flashes
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Outcome_Physical
Simple endometrial hyperplasia
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Outcome_Physical
atypical hyperplasia
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Outcome_Other
leiomyoma regression
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Outcome_Other
improvement in symptoms
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Outcome_Adverse-effects
few side effects