Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
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.
...
Phase:
Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)