Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas.
OBJECTIVE
The primary aim was to assess long-term effects of low-dose mifepristone on myoma regression, symptoms, and endometrial pathology. The secondary aim was to assess regrowth of myomas after cessation of mifepristone.


METHODS
Prospective, open-label, randomized, controlled trial of 5 mg versus 10 mg mifepristone daily for 1 year, in women with large, symptomatic myomas, with variable follow-up among a subset of subjects (Canadian Task Force classification II-2).


METHODS
University research group set in a community hospital.


METHODS
Forty premenopausal women with large, symptomatic myomas.


METHODS
Oral mifepristone 5 or 10 mg daily for 1 year.


RESULTS
Mean uterine volumes decreased in both groups by 48% after 6 months of mifepristone and by 52% to 53 % in both groups after 12 months. Amenorrhea occurred in 61% to 65% at 6 months, and 40% to 70 % at 12 months. Eighty endometrial biopsies were performed. Simple hyperplasia was seen in 5 (13.9 %) of 36 subjects at 6 months and 1 (4.8 %) of 21 at 12 months. All cases of hyperplasia occurred in the 10 mg group. No endometrial sample showed cytologic atypia. Nine women were followed posttreatment for an average of 5.7 months. Uterine volumes increased among most of these subjects, although they remained on average 42% less than baseline.


CONCLUSIONS
Long-term administration of low-dose mifepristone results in myoma shrinkage and amelioration of symptoms; modest rates of low-grade endometrial hyperplasia, but no evidence of premalignant potential, also occur. Regrowth occurs slowly following cessation of the drug.
Eisinger
Steven H
SH
Department of Family Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York 14620, USA. eisinger@rochester.rr.com
Bonfiglio
Thomas
T
Fiscella
Kevin
K
Meldrum
Sean
S
Guzick
David S
DS
D004717:Endometrium / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006727:Hormone Antagonists / Q000008:administration & dosage*; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy* / Q000473:pathology; D015735:Mifepristone / Q000008:administration & dosage*; D011446:Prospective Studies; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000473:pathology
D006727:Hormone Antagonists; D015735:Mifepristone