Table of Contents
ISRN Obstetrics and Gynecology
Volume 2013 (2013), Article ID 649030, 8 pages
http://dx.doi.org/10.1155/2013/649030
Clinical Study

Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial

1Mediterránea Médica Clinic, C/Salvador Guinot 14, 46017 Valencia, Spain
2“Eusebio Hernández” Gynecology and Obstetrics Teaching Hospital, Avenue 31, Calle 82, Marianao, 11300 Havana, Cuba
3University of the Basque Country, 48014 Bilbao, Spain

Received 22 March 2013; Accepted 9 May 2013

Academic Editors: J. A. Cesar and P. G. Larsson

Copyright © 2013 Josep Lluis Carbonell et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objectives. To evaluate the efficacy, safety, and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9-month followup period. Design. Randomized clinical trial. Place. “Eusebio Hernández” Hospital, Havana, Cuba. Subjects. 220 women with symptomatic uterine fibroids. Treatment. One-half (2.5 mg) or one-whole 5 mg mifepristone tablet. Variables to Evaluate Efficacy. Changes in fibroid and uterine volumes, in symptomatic prevalence and intensity, and in quality of life. Results. After 3-month treatment, fibroid volume decreased by 27.9% (CI 95% 20–35) and 45.5% (CI 95% 37–62), in the 2.5 and 5 mg groups, respectively, . There was no difference in the prevalence of symptoms at the end of treatment, unlike after 6- and 9-month followup when there was a difference. Amenorrhea was significantly higher in the 5 mg group, . There were no significant differences in mifepristone side effects between the groups. Both groups displayed a similar improvement in quality of life. Conclusions. The 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose. This trial is registered with ClinicalTrials.gov NCT01786226.