Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: a randomized controlled trial.
OBJECTIVE
To assess the effect of low-dose mifepristone on quality of life, pain, bleeding, and uterine size among women with symptomatic leiomyomata.


METHODS
Forty-two women with symptomatic uterine leiomyomata and uterine volume of 160 mL or more were randomized to mifepristone, 5 mg daily, or placebo for 26 weeks. Quality of life (Uterine Fibroid Symptoms Quality of Life Questionnaire and Medical Outcomes Study 36-Item Short Form survey) and uterine and leiomyoma size (ultrasonography) were assessed at baseline, and at 1 month, 3 months, and 6 months of treatment. Bleeding (daily logs and pictorial charts) and pain (McGill Pain Questionnaire) were assessed monthly. Endometrial pathology was assessed at baseline and 6 months.


RESULTS
Forty-two women were randomized; 37 women completed all 6 months. Women randomized to mifepristone showed an improvement in leiomyoma-specific quality of life. Forty-one percent became amenorrheic, rates of anemia improved, and adjusted uterine size was reduced by 47%. Compared with the placebo group, improvements in these outcomes in the treatment group were significantly greater (P<.05 to .001). There were no significant differences in adverse effects between the groups. No endometrial hyperplasia was noted in any participant.


CONCLUSIONS
Low-dose mifepristone improves leiomyoma-specific quality of life and reduces leiomyoma size among women with symptomatic leiomyomata.


BACKGROUND
ClinicalTrials.gov www.clinicaltrials.gov NCT00133705


METHODS
I.
Fiscella
Kevin
K
Department of Family Medicine, Obstetrics and Gynecology, School of Medicine and Dentistry, University of Rochester, Rochester, New York 14620, USA. Kevin_Fiscella@urmc.rochester.edu
Eisinger
Steven H
SH
Meldrum
Sean
S
Feng
Changyong
C
Fisher
Susan G
SG
Guzick
David S
DS
D000328:Adult; D005260:Female; D006727:Hormone Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D018231:Leiomyomatosis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D008875:Middle Aged; D015735:Mifepristone / Q000008:administration & dosage / Q000627:therapeutic use*; D009929:Organ Size; D010146:Pain; D011788:Quality of Life; D016896:Treatment Outcome; D014463:Ultrasonography; D014594:Uterine Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D014599:Uterus / Q000000981:diagnostic imaging* / Q000473:pathology
D006727:Hormone Antagonists; D015735:Mifepristone