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Hum. Reprod. Advance Access published online on April 23, 2009
Human Reproduction, doi:10.1093/humrep/dep100
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© The Author 2009. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Mifepristone for treatment of uterine leiomyoma. A prospective randomized placebo controlled trial

M. Engman1, S. Granberg2, A.R.W. Williams3, C.X. Meng1, P.G.L. Lalitkumar1 and K. Gemzell-Danielsson1,4

1 Department of Woman and Child Health, Division of Obstetrics and Gynaecology, Karolinska Institutet, Karolinska University Hospital, 171 76 Stockholm, Sweden 2 Department of Obstetrics and Gynaecology, Akershus University Hospital, Oslo, Norway 3 Department of Pathology, University of Edinburgh, Royal Infirmary of Edinburgh, Edinburgh, Scotland, UK

4 Correspondence address. Tel: +46-8-517-721-28; Fax: +46-8-517-743-14; E-mail: kristina.gemzell{at}ki.se

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.

CONCLUSION: 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 [ClinicalTrials.gov] .

Key words: mifepristone/leiomyoma/bleeding/endometrial morphology

Submitted on November 26, 2008; resubmitted on February 25, 2009; accepted on March 20, 2009.


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