Mifepristone for treatment of uterine leiomyoma. A prospective randomized placebo controlled trial
Authors: Engman, M.; Granberg, S.; Williams, A.R.W.; Meng, C.X.; Lalitkumar, P.G.L.; Gemzell-Danielsson, K.
Source: Human Reproduction, Volume 24, Number 8, 29 August 2009 , pp. 1870-1879(10)
Publisher: Oxford University Press
Uterine leiomyomas are widely prevalent and frequently cause menorrhagia. The major therapeutic option today is hysterectomy. Medical options are of highest interest.
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.
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.
Mifepristone may offer an effective treatment option for women with uterine leiomyoma and the associated pronounced uterovaginal bleeding.
Clinical Trials identifier:
Document Type: Research Article
Publication date: 2009-08-29
- Human Reproduction features full-length, peer-reviewed papers reporting original research, clinical case histories, as well as opinions and debates on topical issues. Papers published cover the scientific and medical aspects of reproductive physiology and pathology, endocrinology, andrology, gonad function, gametogenesis, fertilization, embryo development, implantation, pregnancy, genetics, genetic diagnosis, oncology, infectious disease, surgery, contraception, infertility treatment, psychology, ethics and social issues. The highest scientific and editorial standard is maintained throughout the journal along with a rapid rate of publication.