Mifepristone for treatment of uterine leiomyoma. A prospective randomized placebo controlled trial.
BACKGROUND
Uterine leiomyomas are widely prevalent and frequently cause menorrhagia. The major therapeutic option today is hysterectomy. Medical options are of highest interest.


METHODS
A total of 30 women with uterine leiomyomas scheduled for surgical intervention were randomized to receive either 50 mg mifepristone or placebo every other day during 3 months prior to surgery. Uterine blood flow and leiomyoma volume were evaluated once a month until surgery. Endometrial biopsies were obtained prior to and at end of treatment. Relevant biochemistry, symptoms and bleeding were recorded. Primary outcome was reduction in uterine leiomyoma size.


RESULTS
There was a significant percentual decrease (P = 0.021) in the total leiomyoma volume in the mifepristone-treated group, -28 (-48, -8) % (mean +/- 0, 95 confidence interval), compared with the control group values 6 (-13, 25) %. Mifepristone treatment significantly reduced the bleeding days (P = 0.001) and increased serum haemoglobin values (P = 0.046). Serum cortisol levels remained unchanged, while a mild increase in serum androgens was noted. Endometrial biopsies showed no premalignant changes or changes in mitotic indices.


CONCLUSIONS
Mifepristone may offer an effective treatment option for women with uterine leiomyoma and the associated pronounced uterovaginal bleeding. Clinical Trials identifier: www.clinicaltrials.gov: NCT00579475.
Engman
M
M
Department of Woman and Child Health, Division of Obstetrics and Gynaecology, Karolinska Institutet, Karolinska University Hospital, 171 76 Stockholm, Sweden.
Granberg
S
S
Williams
A R W
AR
Meng
C X
CX
Lalitkumar
P G L
PG
Gemzell-Danielsson
K
K
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy* / Q000473:pathology; D008875:Middle Aged; D015735:Mifepristone / Q000627:therapeutic use*; D012039:Regional Blood Flow / Q000187:drug effects; D014592:Uterine Hemorrhage / Q000188:drug therapy; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000473:pathology; D014599:Uterus / Q000098:blood supply
D006454:Hemoglobins; D015735:Mifepristone