Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids

Summary

The purpose of this study is to evaluate the effect of daily dosage of vaginally mifepristone on reduction of uterine fibroids size and the symptoms associated with uterine fibroids.

Timeline

Start

2009-04

Primary completion

2012-05

Completion

2012-07

Publications

• Background Fiscella K, Eisinger SH, Meldrum S, Feng C, Fisher SG, Guzick DS. Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: a randomized controlled trial. Obstet Gynecol. 2006 Dec;108(6):1381-7. doi: 10.1097/01.AOG.0000243776.23391.7b.
• Background Steinauer J, Pritts EA, Jackson R, Jacoby AF. Systematic review of mifepristone for the treatment of uterine leiomyomata. Obstet Gynecol. 2004 Jun;103(6):1331-6. doi: 10.1097/01.AOG.0000127622.63269.8b.
• Background Eisinger SH, Meldrum S, Fiscella K, le Roux HD, Guzick DS. Low-dose mifepristone for uterine leiomyomata. Obstet Gynecol. 2003 Feb;101(2):243-50. doi: 10.1016/s0029-7844(02)02511-5.
• Background Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1.
• Background Eisinger SH, Bonfiglio T, Fiscella K, Meldrum S, Guzick DS. Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas. J Minim Invasive Gynecol. 2005 May-Jun;12(3):227-33. doi: 10.1016/j.jmig.2005.01.022.
• Background Murphy AA, Kettel LM, Morales AJ, Roberts VJ, Yen SS. Regression of uterine leiomyomata in response to the antiprogesterone RU 486. J Clin Endocrinol Metab. 1993 Feb;76(2):513-7. doi: 10.1210/jcem.76.2.8432797.
• Background Yang Y, Zheng S, Li K. [Treatment of uterine leiomyoma by two different doses of mifepristone]. Zhonghua Fu Chan Ke Za Zhi. 1996 Oct;31(10):624-6. Chinese.
• Background Murphy AA, Morales AJ, Kettel LM, Yen SS. Regression of uterine leiomyomata to the antiprogesterone RU486: dose-response effect. Fertil Steril. 1995 Jul;64(1):187-90.
• Yerushalmi GM, Gilboa Y, Jakobson-Setton A, Tadir Y, Goldchmit C, Katz D, Seidman DS. Vaginal mifepristone for the treatment of symptomatic uterine leiomyomata: an open-label study. Fertil Steril. 2014 Feb;101(2):496-500. doi: 10.1016/j.fertnstert.2013.10.015. Epub 2013 Nov 9.

Drugs

Indications