Treatment of Leiomyomata With the Selective Progesterone Receptor Modulator CDB-2914
Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in
premenopausal women. These tumors may cause bleeding, pelvic pain and pressure. Because
fibroids grow in the presence of estrogen, medical therapies that decrease estrogen levels
(like GnRH analog) cause fibroids to shrink and so may relieve symptoms. However, such
medication can only be given short-term and has inconvenient side effects such as
hot-flushes. Thus, many women with symptomatic fibroids choose to have them removed
surgically, either individually or by removing the uterus via hysterectomy.
The study evaluates a new medical treatment for fibroids using the progesterone receptor
modulator CDB-2914. A similar compound, mifepristone (Registered Trademark), reduced
fibroid size when given for twelve weeks. This study will compare fibroid size, hormone
levels and symptoms before and during daily administration of CDB-2914 (10 or 25 mg) or
placebo for 10 - 14 weeks. To do this, women will undergo MRI and a saline hysterosonogram
(ultrasound with fluid) of the uterus before and at the end of the treatment; they will have
blood drawn every 7 - 14 days, and will fill out a symptom calendar at home. Hysterectomy
will be performed at the end of the treatment to evaluate the effects of the medication on
the uterine and fibroid tissues, and to provide treatment for the study participant. Women
will be randomly assigned to the treatment groups; during the treatment period neither the
participants nor the investigators will know the type of treatment that a woman receives.
Primary Purpose: Treatment
Lynnette K Nieman, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|